MVA85A booster × Added tuberculosis prevention after BCG — Evidence checklist

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Efficacy comparison and presentation of stored materialWhat are the subclaim and parent values for added protection after BCG?Required	The selected existing question is 'added tuberculosis prevention after BCG', with D grade and the note 'There was no significant benefit'. Parent D34, Caution and original H/R1/I1/E0/B1/C0 axes are parent context; the subclaim has no score, status or axes. S01	This is a record from the stored summary. Some information exists in the stored summary, but No new vaccine grade or score is created, and parent values are not inherited. Review of existing content remains incomplete.	Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes	A proposal for follow-up materials linking Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes as a separate item; no new research, calculation or testing is performed in this preparation.
2	Partly verified	Full text not readStored summary read	N02 · Efficacy comparison and presentation of stored materialWere participants studied before BCG vaccination or as already vaccinated infants?Required	The original condition is a study of healthy infants who had all already received BCG. It is not extended to unvaccinated children, adults, other immune states or all infants. S01	This is a record from the stored summary. Some information exists in the stored summary, but Exact ages, location/exposure setting, inclusion/exclusion criteria and baseline immune/infection status remain unverified. Review of existing content remains incomplete.	Healthy, already vaccinated infants and the actual selection, age and setting boundaries	A proposal for follow-up materials linking Healthy, already vaccinated infants and the actual selection, age and setting boundaries as a separate item; no new research, calculation or testing is performed in this preparation.
3	Partly verified	Full text not readStored summary read	N03 · Efficacy comparison and presentation of stored materialAre added MVA85A and the effect of BCG itself the same question?Required	The original comparison is an MVA85A booster added after BCG versus placebo. It is not changed to efficacy of first BCG vaccination, an unvaccinated control, replacement of BCG or effects of all boosters. S01	This is a record from the stored summary. Some information exists in the stored summary, but Timing/type of BCG, booster interval/exposure, control composition and concomitant interventions remain unverified. Review of existing content remains incomplete.	BCG in both groups, the added candidate effect and comparison with placebo	A proposal for follow-up materials linking BCG in both groups, the added candidate effect and comparison with placebo as a separate item; no new research, calculation or testing is performed in this preparation.
4	Partly verified	Full text not readStored summary read	N04 · Efficacy comparison and presentation of stored materialWhat research condition defines MVA85A?Required	The existing research-product description states that MVA85A is a modified vaccinia Ankara vector expressing antigen 85A. This identity does not establish equivalence with existing BCG, other boosters or products, or provide vaccination/suitability guidance. S01	This is a record from the stored summary. Some information exists in the stored summary, but Original dose, route, number of doses, batch/quality, actual exposure and equivalence with other products remain unverified. Review of existing content remains incomplete.	Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization	A proposal for follow-up materials linking Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization as a separate item; no new research, calculation or testing is performed in this preparation.
5	Partly verified	Full text not readStored summary read	N05 · Efficacy comparison and presentation of stored materialWhat is known about allocation and assessment in the double-blind phase 2b design?Required	The original study is a double-blind, placebo-controlled phase 2b RCT. The original B1 axis and double-blind label alone do not verify sequence generation, allocation concealment or blinding of all case assessments and follow-up. S01	This is a record from the stored summary. Some information exists in the stored summary, but Allocation/group ratio, placebo identity, assessor awareness and detailed case adjudication remain unverified. Review of existing content remains incomplete.	Randomization/placebo, allocation concealment and tuberculosis case adjudication	A proposal for follow-up materials linking Randomization/placebo, allocation concealment and tuberculosis case adjudication as a separate item; no new research, calculation or testing is performed in this preparation.
6	Partly verified	Full text not readStored summary read	N06 · Efficacy comparison and presentation of stored materialHow do 2797 participants differ from tuberculosis denominators 1399/1395?Required	The original trial size of 2797 and tuberculosis results 32/1399 versus 39/1395 are preserved separately. Group denominators are not added or subtracted to calculate new missing/excluded counts or completion rates. S01	This is a record from the stored summary. Some information exists in the stored summary, but Randomized/analyzed counts by group, exclusions/losses/missing data and actual follow-up durations remain unverified. Review of existing content remains incomplete.	Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions	A proposal for follow-up materials linking Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions as a separate item; no new research, calculation or testing is performed in this preparation.
7	Partly verified	Full text not readStored summary read	N07 · Efficacy comparison and presentation of stored materialHow were incident tuberculosis cases defined and adjudicated?Required	The original endpoint is tuberculosis incidence. Definitions of active/confirmed/clinical tuberculosis, microbiological criteria and severity/site-specific results are not filled in from definitions absent from this summary. S01	This is a record from the stored summary. Some information exists in the stored summary, but Case criteria, testing/confirmation, adjudication/follow-up, components and recurrent events remain unverified. Review of existing content remains incomplete.	Incident TB, clinical/test/severity definitions and case collection criteria	A proposal for follow-up materials linking Incident TB, clinical/test/severity definitions and case collection criteria as a separate item; no new research, calculation or testing is performed in this preparation.
8	Unverified	Full text not readStored summary read	N08 · Efficacy comparison and presentation of stored materialAre tuberculosis disease, infection and immune response the same outcome?Required	The quantitative result in the current stored summary is tuberculosis disease incidence. The summary is not presented as providing numerical results for infection incidence, test conversion or immune response/preventive effects. S01	This is a record from the stored summary. The currently required information remains unverified. Definitions, measurements, values/denominators/CIs and hierarchy of infection/immune endpoints remain unverified. Review of existing content remains incomplete.	Separate definitions/denominators for disease and infection/immune surrogate markers	A proposal for follow-up materials linking Separate definitions/denominators for disease and infection/immune surrogate markers as a separate item; no new research, calculation or testing is performed in this preparation.
9	Partly verified	Full text not readStored summary read	N09 · Efficacy comparison and presentation of stored materialDoes up to 37 months mean the same observation period for everyone?Required	The existing research description states follow-up up to 37 months. This is not changed to 37-month completion by everyone, incidence over a fixed duration or lifelong prevention, and no new person-time or annualized rate is calculated. S01	This is a record from the stored summary. Some information exists in the stored summary, but Individual/group follow-up, median duration, censoring/missing data and first/recurrent disease rules remain unverified. Review of existing content remains incomplete.	Maximum follow-up, duration/censoring and first/recurrent event units	A proposal for follow-up materials linking Maximum follow-up, duration/censoring and first/recurrent event units as a separate item; no new research, calculation or testing is performed in this preparation.
10	Partly verified	Full text not readStored summary read	N10 · Efficacy comparison and presentation of stored materialWhich groups do the tuberculosis fractions, proportions and absolute difference describe?Required	Preserves original MVA85A 32/1399 (2.3%) versus control 39/1395 (2.8%), and absolute difference −.5%p. No new difference, incidence rate, NNT, absolute-difference CI or individual protection probability is calculated. S01	This is a record from the stored summary. Some information exists in the stored summary, but Exact denominators/analysis specification, absolute-difference CI, exposure/follow-up and models remain unverified. Review of existing content remains incomplete.	MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p	A proposal for follow-up materials linking MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p as a separate item; no new research, calculation or testing is performed in this preparation.
11	Partly verified	Full text not readStored summary read	N11 · Efficacy comparison and presentation of stored materialWhat possibilities remain within the interval around vaccine efficacy 17.3%?Required	The original Korean account states that vaccine efficacy 17.3% (95% CI −31.9~48.2) leaves possibilities in both benefit and harm directions. The finding of no significant benefit is not changed to an exact effect of 0, equivalence, exclusion of all important benefits or safety. S01	This is a record from the stored summary. Some information exists in the stored summary, but Efficacy model, covariates/censoring, original P value, importance threshold and subgroups remain unverified. Review of existing content remains incomplete.	Original 17.3%, 95% CI −31.9~48.2, model and comparison direction	A proposal for follow-up materials linking Original 17.3%, 95% CI −31.9~48.2, model and comparison direction as a separate item; no new research, calculation or testing is performed in this preparation.
12	Partly verified	Full text not readStored summary read	N12 · Efficacy comparison and presentation of stored materialHow are the finding of no significant benefit or candidate success and the wide interval preserved together?Required	The existing central summary/grade records no significant reduction in disease and D34. The interval −31.9~48.2 and wording allowing substantial benefit are also preserved, without a new significance, grade or overall vaccine-effect judgment. S01	This is a record from the stored summary. Some information exists in the stored summary, but Clinically important efficacy threshold, planned statistical power and exact P value/model remain unverified. Review of existing content remains incomplete.	Original D34/E0, no significant benefit and precision of the original CI	A proposal for follow-up materials linking Original D34/E0, no significant benefit and precision of the original CI as a separate item; no new research, calculation or testing is performed in this preparation.
13	Partly verified	Full text not readStored summary read	N13 · Efficacy comparison and presentation of stored materialWhat prespecified analysis/endpoint specification applies to tuberculosis disease?Required	The original is a large candidate vaccine trial of tuberculosis disease. Infection, immune responses, safety, other periods or subgroups are not promoted to the main efficacy outcome. S01	This is a record from the stored summary. Some information exists in the stored summary, but Registration/protocol/SAP, endpoint hierarchy/multiplicity and denominator/missing-data plans remain unverified. Review of existing content remains incomplete.	Original main disease time point, prespecified hierarchy, infection/safety and multiplicity	A proposal for follow-up materials linking Original main disease time point, prespecified hierarchy, infection/safety and multiplicity as a separate item; no new research, calculation or testing is performed in this preparation.
14	Partly verified	Full text not readStored summary read	N14 · Efficacy comparison and presentation of stored materialHow do actual exposure, BCG/concomitant interventions and follow-up measures relate to the added effect?Required	The original comparison is an added candidate strategy after BCG in both groups. Actual MVA/control adherence, crossover, other vaccines, prevention/treatment or exposure differences are not newly filled in. S01	This is a record from the stored summary. Some information exists in the stored summary, but Actual exposures by group, concurrent measures/deviations, infection risks/treatment and event times remain unverified. Review of existing content remains incomplete.	Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses	A proposal for follow-up materials linking Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses as a separate item; no new research, calculation or testing is performed in this preparation.
15	Partly verified	Full text not readStored summary read	N15 · Efficacy comparison and presentation of stored materialAre one trial, the parent/this sheet and different outcomes kept from becoming new independent counts?Required	Tameris2013MVA85A020 is one existing clinical report. The parent disease judgment, this sheet, safety outcomes, repeated time points or groups are not added as new independent trials or total participants. S01	This is a record from the stored summary. Some information exists in the stored summary, but Unique clinical trial, participant and independent replication totals have not been verified and are not recorded. Review of existing content remains incomplete.	The same MVA85A020 trial, shared denominators/durations and added-effect question	A proposal for follow-up materials linking The same MVA85A020 trial, shared denominators/durations and added-effect question as a separate item; no new research, calculation or testing is performed in this preparation.
16	Partly verified	Full text not readStored summary read	N16 · Efficacy comparison and presentation of stored materialIs the 1245 first BCG vaccination manuscript a direct trial of an added booster?Required	Existing cross-citation 1245 refers to a first BCG vaccination manuscript in unvaccinated children, B64. That manuscript/trial has not been read in this preparation and is not created as a direct trial or same-population replication of the added MVA effect. S02	This is a record from the stored summary. Some information exists in the stored summary, but That original manuscript/trial, conditions/denominators and direct linkage remain unverified. Review of existing content remains incomplete.	Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants	A proposal for follow-up materials linking Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants as a separate item; no new research, calculation or testing is performed in this preparation.
17	Partly verified	Full text not readStored summary read	N17 · Efficacy comparison and presentation of stored materialIs the 2743 shortened pulmonary tuberculosis treatment reference a preventive vaccine result?Required	Existing cross-citation 2743 refers to shortened treatment of established pulmonary tuberculosis, C56. The original title/relative URL is preserved, without changing it to a preventive effect, an independent vaccine trial or treatment guidance. S03	This is a record from the stored summary. Some information exists in the stored summary, but That manuscript/trial has not been read and is not a direct result for a preventive booster. Review of existing content remains incomplete.	Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention	A proposal for follow-up materials linking Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention as a separate item; no new research, calculation or testing is performed in this preparation.
18	Partly verified	Full text not readStored summary read	N18 · Efficacy comparison and presentation of stored materialWhat are the Aeras/Wellcome/OETC relationships and commercial rights?Required	Original funding names Aeras, Wellcome Trust and the Oxford-Emergent Tuberculosis Consortium. Oxford development and Emergent commercialization rights/consortium participation are preserved as the original history of mixed independence. S01	This is a record from the stored summary. Some information exists in the stored summary, but Specific support/products, employee authors, design/analysis/manuscript roles and COI/rights agreements have not been read in external sources. Review of existing content remains incomplete.	Nonprofit/development consortium, Oxford/Emergent relationships and actual roles	A proposal for follow-up materials linking Nonprofit/development consortium, Oxford/Emergent relationships and actual roles as a separate item; no new research, calculation or testing is performed in this preparation.
19	Partly verified	Full text not readStored summary read	N19 · Efficacy comparison and presentation of stored materialDo development rights and mixed funding verify all COI and product support?Required	Original mixed funding and commercial development involvement are not expanded into new certification of product provision, all employee authors, all COI or absence of researcher independence. The original I1 axis is preserved as history. S01	This is a record from the stored summary. Some information exists in the stored summary, but Individual relationships, product/placebo support, data/publication authority and author contributions remain unverified. Review of existing content remains incomplete.	Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority	A proposal for follow-up materials linking Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority as a separate item; no new research, calculation or testing is performed in this preparation.
20	Partly verified	Full text not readStored summary read	N20 · Efficacy comparison and presentation of stored materialWere the registration number and prespecified disease/infection plans actually read?Required	Preserves original NCT00953927. The number/manuscript account alone does not establish actual reading of the registry, protocol or SAP, or fulfillment of prespecified disease/infection conditions. S01	This is a record from the stored summary. Some information exists in the stored summary, but Original registration/change history, endpoint definitions/denominators and multiplicity/missing-data plans have not been read. Review of existing content remains incomplete.	NCT00953927 record, plans/change history, missing data and hierarchy	A proposal for follow-up materials linking NCT00953927 record, plans/change history, missing data and hierarchy as a separate item; no new research, calculation or testing is performed in this preparation.
21	Partly verified	Full text not readStored summary read	N21 · Harm-information gaps supplementing the efficacy tableWhat denominators and periods apply to local, systemic and serious adverse events?Supplementary	Preserves local events 89% versus 45%, systemic events 80% versus 76% and serious events 18% versus 18%. Differences, risk ratios, event counts or disease denominators are not newly calculated, and these results are not combined into one safety rate. S01	This is a record from the stored summary. Some information exists in the stored summary, but Each definition/collection process, people/events, groups/denominators, duration/recurrence and CI/P value remain unverified. Review of existing content remains incomplete.	Distinct safety specifications for original 89/45%, 80/76% and 18/18%	A proposal for follow-up materials linking Distinct safety specifications for original 89/45%, 80/76% and 18/18% as a separate item; no new research, calculation or testing is performed in this preparation.
22	Partly verified	Full text not readStored summary read	N22 · Harm-information gaps supplementing the efficacy tableDoes absence of related serious events mean zero risk or a vaccination recommendation?Supplementary	The original states that there were no related serious adverse events, while all serious events 18%/18% are separate. Wording about absence of related events is not changed to zero risk, safety of all vaccines/long-term use or a vaccination/suitability recommendation. S01	This is a record from the stored summary. Some information exists in the stored summary, but Causality assessment/collection, exposure/loss to follow-up and rare, vulnerable-population or long-term harms remain unverified. Review of existing content remains incomplete.	Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms	A proposal for follow-up materials linking Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms as a separate item; no new research, calculation or testing is performed in this preparation.
23	Partly verified	Full text not readStored summary read	N23 · Efficacy comparison and presentation of stored materialCan the result be generalized to BCG policy, other candidates/populations, prevention or treatment?Required	This sheet contains historical original material on the added effect of that candidate. Original wording about Korean national BCG immunization is preserved in the full stored summary, without newly confirming current policy or creating guidance on vaccine selection, use, suitability, treatment or prevention. S01 S02 S03	This is a record from the stored summary. Some information exists in the stored summary, but New confirmation of other boosters/populations/long-term outcomes and current policy is outside scope/unverified. Review of existing content remains incomplete.	Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases	A proposal for follow-up materials linking Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases as a separate item; no new research, calculation or testing is performed in this preparation.
24	Partly verified	Full text not readStored summary read	N24 · Efficacy comparison and presentation of stored materialWhat was actually read of the stored summary, external papers/manuscripts and links?Required	The full stored summary was read for preparation and labeled 'Summary read'. Original clinical-report and relative BCG/shortened-treatment URLs are preserved; external full papers/manuscripts, registration/plans and COI are labeled 'Not read'. Existing cross-citation checks are not inherited as current content review. S01 S02 S03	This is a record from the stored summary. Some information exists in the stored summary, but External access, abstracts/full texts, link/click testing and comparison with original papers were not performed. Review of existing content remains incomplete.	Full stored summary, PMID23391465/two reference URLs and unread external sources	A proposal for follow-up materials linking Full stored summary, PMID23391465/two reference URLs and unread external sources as a separate item; no new research, calculation or testing is performed in this preparation.
25	Partly verified	Full text not readStored summary read	N25 · Efficacy comparison and presentation of stored materialHow are existing Korean/English manuscripts, D34/axes, dates and empty values preserved?Required	Preserves the full stored summary's Korean/English manuscripts, parent D34/Caution, original axes/false values, empty correction and deliberation records, and 2026-08-26. Absent subclaim D score, status or axes are not filled with parent values. S01 S02 S03	This is a record from the stored summary. Some information exists in the stored summary, but The historical preparation records that translation, correction, reassessment, clinical original-paper review or external updating of the original judgment were not performed then. Review of existing content remains incomplete.	Subclaim D, parent D34, 2026-08-26, false/empty values and correction history	A proposal for follow-up materials linking Subclaim D, parent D34, 2026-08-26, false/empty values and correction history as a separate item; no new research, calculation or testing is performed in this preparation.
26	Partly verified	Full text not readStored summary read	N26 · Efficacy comparison and presentation of stored materialHow are condition preservation/application, case preparation and content review distinguished?Required	Condition preservation, freezing, application, case production and content review are separate records. Review of the existing content is incomplete; record counts are not totals of unique clinical trials/participants. S01 S02 S03	Record from the stored summary. Some information is in the stored summary. Review of the existing content is incomplete and clinical source material was not newly verified. Review of the existing content remains incomplete.	Records of condition preservation, freezing/application, case preparation and incomplete content review	A proposal for follow-up materials linking Records of condition preservation, freezing/application, case preparation and incomplete content review as a separate item; no new research, calculation or testing is performed in this preparation.

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26 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: Healthy infants already vaccinated with BCG; distinguish the original 2797 participants from the tuberculosis denominators 1399/1395
Ingredient, formulation and route: Addition of the original MVA85A candidate booster after BCG in both groups; no instruction on vaccine selection or use
Dose: Not recorded
Comparator: MVA85A versus placebo after BCG; separate from first BCG vaccination, an unvaccinated control or treatment of established disease
Measured outcome: Original tuberculosis incidence 32/1399 versus 39/1395; efficacy 17.3% (CI −31.9~48.2); infection and immune-response values remain unverified
Duration: Follow-up up to 37 months; no extension to the same fixed duration for everyone or lifelong prevention
Questions outside this scope: Applying the added MVA candidate result to BCG itself, unvaccinated children or the effects of all boosters or vaccines; Calculating new totals, missing counts, denominators, rates, absolute differences, effects, CIs, NNTs or individual protection probabilities from 2797 and 1399/1395; Applying disease-incidence results to tuberculosis infection, test conversion, immune responses or confirmed prevention, or filling in new definitions; Changing follow-up up to 37 months to the same duration for everyone, person-time, annualized rates, lifelong effects or effects in other populations; Applying efficacy 17.3/CI −31.9~48.2 and the original finding of no significant benefit to an exact effect of 0, equivalence, exclusion of all important benefits or overall safety; Creating direct trials or replicated effects of added MVA from 1245 first BCG vaccination B64 or 2743 shortened treatment of established disease C56; Changing local 89/45, systemic 80/76 and serious 18/18 events or the absence of related serious events to one safety rate or difference, zero risk or individual suitability; Extending mixed funding, commercial rights or I1 to free products, individual employees, COI, full decision-making authority or certification of independence; Using the original wording about Korean BCG policy as confirmation of current policy or guidance on vaccine selection, vaccination, route, dose or treatment; Adding references to the same report, trial, population, group, time point, sibling question or manuscript as new independent trials or total participants; Inheriting the parent score or axes, historical cross-checks, original-paper review or existing cross-citation checks as subclaim values, current content review or external reading; New searches or APIs, numerical calculations, hypothetical values, new effects, CIs or grades, certification of independence, or guidance on antibiotic or vaccine selection, use, suitability or treatment

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · Tameris et al. 2013 MVA85A 020

PubMed

Material type: Double-blind, placebo-controlled phase 2b RCT
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: 32/1399 versus 39/1395; efficacy 17.3% (95% CI -31.9~48.2), absolute difference -0.5%p. Preserves the disease proportions and wide efficacy interval in the existing reader answer, and the original D34/subclaim D. Denominators are not added or subtracted, and new rates, effects, CIs or individual predictions are not calculated. Infection/immune-response values, exact follow-up and endpoint definitions remain unverified.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 Tameris2013MVA85A020/PMID23391465 is a double-blind, placebo-controlled phase 2b candidate trial in 2797 healthy infants already vaccinated with BCG. Tuberculosis denominators 1399/1395, follow-up up to 37 months, and infection, immune-response and safety endpoints are kept separate. The historical finding of no significant benefit and the wide efficacy interval are both preserved. The same report/population, sibling questions, groups, time points, denominators or manuscript references are not added as new independent trials or participants. Report/material entries are not unique clinical totals, and the independent total is null. S02 is a manuscript reference in the existing cross-citations to 1245, first BCG vaccination and active tuberculosis in unvaccinated children, B64. The linked manuscript/trial has not been read in this preparation, and its question, population, exposure and endpoint differ from additional MVA prevention in already vaccinated infants. The same report/population, sibling questions, groups, time points, denominators or manuscript references are not added as new independent trials or participants. Report/material entries are not unique clinical totals, and the independent total is null. S03 is a manuscript reference in the existing cross-citations to 2743, shortened treatment of established drug-susceptible pulmonary tuberculosis, C56. The linked manuscript/trial has not been read in this preparation, and its question, population, exposure and endpoint differ from additional MVA prevention in already vaccinated infants. The same report/population, sibling questions, groups, time points, denominators or manuscript references are not added as new independent trials or participants. Report/material entries are not unique clinical totals, and the independent total is null.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S02 · 1245 First BCG vaccination × Active tuberculosis in unvaccinated children (B 64)

Official source

Material type: Citation-only report; no row in the original review summary's evidence list
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: BCG itself and an added booster are different questions. Existing cross-citation checks and bibliographic records are preserved as history; clinical content, judgments or numbers are not transferred as direct values for the selected question.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 Tameris2013MVA85A020/PMID23391465 is a double-blind, placebo-controlled phase 2b candidate trial in 2797 healthy infants already vaccinated with BCG. Tuberculosis denominators 1399/1395, follow-up up to 37 months, and infection, immune-response and safety endpoints are kept separate. The historical finding of no significant benefit and the wide efficacy interval are both preserved. The same report/population, sibling questions, groups, time points, denominators or manuscript references are not added as new independent trials or participants. Report/material entries are not unique clinical totals, and the independent total is null. S02 is a manuscript reference in the existing cross-citations to 1245, first BCG vaccination and active tuberculosis in unvaccinated children, B64. The linked manuscript/trial has not been read in this preparation, and its question, population, exposure and endpoint differ from additional MVA prevention in already vaccinated infants. The same report/population, sibling questions, groups, time points, denominators or manuscript references are not added as new independent trials or participants. Report/material entries are not unique clinical totals, and the independent total is null. S03 is a manuscript reference in the existing cross-citations to 2743, shortened treatment of established drug-susceptible pulmonary tuberculosis, C56. The linked manuscript/trial has not been read in this preparation, and its question, population, exposure and endpoint differ from additional MVA prevention in already vaccinated infants. The same report/population, sibling questions, groups, time points, denominators or manuscript references are not added as new independent trials or participants. Report/material entries are not unique clinical totals, and the independent total is null.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review.
External manuscript	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S03 · 2743 Four months of rifapentine and moxifloxacin × Shortened treatment of drug-susceptible pulmonary tuberculosis (C 56)

Official source

Material type: Citation-only report; no row in the original review summary's evidence list
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: Prevention and shortened treatment are different questions. Existing cross-citation checks and bibliographic records are preserved as history; clinical content, judgments or numbers are not transferred as direct values for the selected question.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 Tameris2013MVA85A020/PMID23391465 is a double-blind, placebo-controlled phase 2b candidate trial in 2797 healthy infants already vaccinated with BCG. Tuberculosis denominators 1399/1395, follow-up up to 37 months, and infection, immune-response and safety endpoints are kept separate. The historical finding of no significant benefit and the wide efficacy interval are both preserved. The same report/population, sibling questions, groups, time points, denominators or manuscript references are not added as new independent trials or participants. Report/material entries are not unique clinical totals, and the independent total is null. S02 is a manuscript reference in the existing cross-citations to 1245, first BCG vaccination and active tuberculosis in unvaccinated children, B64. The linked manuscript/trial has not been read in this preparation, and its question, population, exposure and endpoint differ from additional MVA prevention in already vaccinated infants. The same report/population, sibling questions, groups, time points, denominators or manuscript references are not added as new independent trials or participants. Report/material entries are not unique clinical totals, and the independent total is null. S03 is a manuscript reference in the existing cross-citations to 2743, shortened treatment of established drug-susceptible pulmonary tuberculosis, C56. The linked manuscript/trial has not been read in this preparation, and its question, population, exposure and endpoint differ from additional MVA prevention in already vaccinated infants. The same report/population, sibling questions, groups, time points, denominators or manuscript references are not added as new independent trials or participants. Report/material entries are not unique clinical totals, and the independent total is null.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review.
External manuscript	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

Report counts versus independent study counts

S01 Tameris2013MVA85A020/PMID23391465 is a double-blind, placebo-controlled phase 2b candidate trial in 2797 healthy infants already vaccinated with BCG. Tuberculosis denominators 1399/1395, follow-up up to 37 months, and infection, immune-response and safety endpoints are kept separate. The historical finding of no significant benefit and the wide efficacy interval are both preserved. The same report/population, sibling questions, groups, time points, denominators or manuscript references are not added as new independent trials or participants. Report/material entries are not unique clinical totals, and the independent total is null. S02 is a manuscript reference in the existing cross-citations to 1245, first BCG vaccination and active tuberculosis in unvaccinated children, B64. The linked manuscript/trial has not been read in this preparation, and its question, population, exposure and endpoint differ from additional MVA prevention in already vaccinated infants. The same report/population, sibling questions, groups, time points, denominators or manuscript references are not added as new independent trials or participants. Report/material entries are not unique clinical totals, and the independent total is null. S03 is a manuscript reference in the existing cross-citations to 2743, shortened treatment of established drug-susceptible pulmonary tuberculosis, C56. The linked manuscript/trial has not been read in this preparation, and its question, population, exposure and endpoint differ from additional MVA prevention in already vaccinated infants. The same report/population, sibling questions, groups, time points, denominators or manuscript references are not added as new independent trials or participants. Report/material entries are not unique clinical totals, and the independent total is null.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · What are the subclaim and parent values for added protection after BCG?

Required materials and conditions: Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes
Conditions for verification: Relevant original materials and the scope of analysis for Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes and connect the selected question's required materials with the available materials.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N02 · Were participants studied before BCG vaccination or as already vaccinated infants?

Required materials and conditions: Healthy, already vaccinated infants and the actual selection, age and setting boundaries
Conditions for verification: Relevant original materials and the scope of analysis for Healthy, already vaccinated infants and the actual selection, age and setting boundaries must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Healthy, already vaccinated infants and the actual selection, age and setting boundaries and connect the selected question's required materials with the available materials.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

N03 · Are added MVA85A and the effect of BCG itself the same question?

Required materials and conditions: BCG in both groups, the added candidate effect and comparison with placebo
Conditions for verification: Relevant original materials and the scope of analysis for BCG in both groups, the added candidate effect and comparison with placebo must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish BCG in both groups, the added candidate effect and comparison with placebo and connect the selected question's required materials with the available materials.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

N04 · What research condition defines MVA85A?

Required materials and conditions: Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization
Conditions for verification: Relevant original materials and the scope of analysis for Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization and connect the selected question's required materials with the available materials.
Referenced methods: M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design

N05 · What is known about allocation and assessment in the double-blind phase 2b design?

Required materials and conditions: Randomization/placebo, allocation concealment and tuberculosis case adjudication
Conditions for verification: Relevant original materials and the scope of analysis for Randomization/placebo, allocation concealment and tuberculosis case adjudication must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Randomization/placebo, allocation concealment and tuberculosis case adjudication and connect the selected question's required materials with the available materials.
Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

N06 · How do 2797 participants differ from tuberculosis denominators 1399/1395?

Required materials and conditions: Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions
Conditions for verification: Relevant original materials and the scope of analysis for Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions and connect the selected question's required materials with the available materials.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

N07 · How were incident tuberculosis cases defined and adjudicated?

Required materials and conditions: Incident TB, clinical/test/severity definitions and case collection criteria
Conditions for verification: Relevant original materials and the scope of analysis for Incident TB, clinical/test/severity definitions and case collection criteria must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Incident TB, clinical/test/severity definitions and case collection criteria and connect the selected question's required materials with the available materials.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation to each question is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application

N08 · Are tuberculosis disease, infection and immune response the same outcome?

Required materials and conditions: Separate definitions/denominators for disease and infection/immune surrogate markers
Conditions for verification: Relevant original materials and the scope of analysis for Separate definitions/denominators for disease and infection/immune surrogate markers must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Separate definitions/denominators for disease and infection/immune surrogate markers and connect the selected question's required materials with the available materials.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension

N09 · Does up to 37 months mean the same observation period for everyone?

Required materials and conditions: Maximum follow-up, duration/censoring and first/recurrent event units
Conditions for verification: Relevant original materials and the scope of analysis for Maximum follow-up, duration/censoring and first/recurrent event units must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Maximum follow-up, duration/censoring and first/recurrent event units and connect the selected question's required materials with the available materials.
Referenced methods: M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design

N10 · Which groups do the tuberculosis fractions, proportions and absolute difference describe?

Required materials and conditions: MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p
Conditions for verification: Relevant original materials and the scope of analysis for MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p and connect the selected question's required materials with the available materials.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application

N11 · What possibilities remain within the interval around vaccine efficacy 17.3%?

Required materials and conditions: Original 17.3%, 95% CI −31.9~48.2, model and comparison direction
Conditions for verification: Relevant original materials and the scope of analysis for Original 17.3%, 95% CI −31.9~48.2, model and comparison direction must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Original 17.3%, 95% CI −31.9~48.2, model and comparison direction and connect the selected question's required materials with the available materials.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application

N12 · How are the finding of no significant benefit or candidate success and the wide interval preserved together?

Required materials and conditions: Original D34/E0, no significant benefit and precision of the original CI
Conditions for verification: Relevant original materials and the scope of analysis for Original D34/E0, no significant benefit and precision of the original CI must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Original D34/E0, no significant benefit and precision of the original CI and connect the selected question's required materials with the available materials.
Referenced methods: M04 §4.6.3 and M15 §15.3.1–15.3.3; Status separation is Chamgap design; M15 §15.3.1–15.3.3; Chamgap application

N13 · What prespecified analysis/endpoint specification applies to tuberculosis disease?

Required materials and conditions: Original main disease time point, prespecified hierarchy, infection/safety and multiplicity
Conditions for verification: Relevant original materials and the scope of analysis for Original main disease time point, prespecified hierarchy, infection/safety and multiplicity must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Original main disease time point, prespecified hierarchy, infection/safety and multiplicity and connect the selected question's required materials with the available materials.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application

N14 · How do actual exposure, BCG/concomitant interventions and follow-up measures relate to the added effect?

Required materials and conditions: Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses
Conditions for verification: Relevant original materials and the scope of analysis for Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses and connect the selected question's required materials with the available materials.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; design considerations in M19 §19.2.2–19.2.4; detailed confounding records are internally designed

N15 · Are one trial, the parent/this sheet and different outcomes kept from becoming new independent counts?

Required materials and conditions: The same MVA85A020 trial, shared denominators/durations and added-effect question
Conditions for verification: Relevant original materials and the scope of analysis for The same MVA85A020 trial, shared denominators/durations and added-effect question must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish The same MVA85A020 trial, shared denominators/durations and added-effect question and connect the selected question's required materials with the available materials.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

N16 · Is the 1245 first BCG vaccination manuscript a direct trial of an added booster?

Required materials and conditions: Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants
Conditions for verification: Relevant original materials and the scope of analysis for Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants and connect the selected question's required materials with the available materials.
Referenced methods: Question clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; M03 §3.2.1; detailed population conditions are internally designed

N17 · Is the 2743 shortened pulmonary tuberculosis treatment reference a preventive vaccine result?

Required materials and conditions: Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention
Conditions for verification: Relevant original materials and the scope of analysis for Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention and connect the selected question's required materials with the available materials.
Referenced methods: Question clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptation are internally designed

N18 · What are the Aeras/Wellcome/OETC relationships and commercial rights?

Required materials and conditions: Nonprofit/development consortium, Oxford/Emergent relationships and actual roles
Conditions for verification: Relevant original materials and the scope of analysis for Nonprofit/development consortium, Oxford/Emergent relationships and actual roles must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Nonprofit/development consortium, Oxford/Emergent relationships and actual roles and connect the selected question's required materials with the available materials.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N19 · Do development rights and mixed funding verify all COI and product support?

Required materials and conditions: Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority
Conditions for verification: Relevant original materials and the scope of analysis for Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority and connect the selected question's required materials with the available materials.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N20 · Were the registration number and prespecified disease/infection plans actually read?

Required materials and conditions: NCT00953927 record, plans/change history, missing data and hierarchy
Conditions for verification: Relevant original materials and the scope of analysis for NCT00953927 record, plans/change history, missing data and hierarchy must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish NCT00953927 record, plans/change history, missing data and hierarchy and connect the selected question's required materials with the available materials.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

N21 · What denominators and periods apply to local, systemic and serious adverse events?

Required materials and conditions: Distinct safety specifications for original 89/45%, 80/76% and 18/18%
Conditions for verification: Relevant original materials and the scope of analysis for Distinct safety specifications for original 89/45%, 80/76% and 18/18% must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Supplementary
Application exceptions: Addresses gaps in harm information for the selected recurrence/additional tuberculosis prevention question. Original efficacy, recurrence or safety wording is not used to judge overall safety or generate harm rates or guidance on antibiotic or vaccine selection, use or suitability.
Why this condition is needed: An item prepared to distinguish Distinct safety specifications for original 89/45%, 80/76% and 18/18% and connect the selected question's required materials with the available materials.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4; internal application

N22 · Does absence of related serious events mean zero risk or a vaccination recommendation?

Required materials and conditions: Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms
Conditions for verification: Relevant original materials and the scope of analysis for Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Supplementary
Application exceptions: Addresses gaps in harm information for the selected recurrence/additional tuberculosis prevention question. Original efficacy, recurrence or safety wording is not used to judge overall safety or generate harm rates or guidance on antibiotic or vaccine selection, use or suitability.
Why this condition is needed: An item prepared to distinguish Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms and connect the selected question's required materials with the available materials.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4; internal application; Chamgap's own interpretation boundary. Refers to M19 principles; no formal causality tool was applied.

N23 · Can the result be generalized to BCG policy, other candidates/populations, prevention or treatment?

Required materials and conditions: Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases
Conditions for verification: Relevant original materials and the scope of analysis for Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases and connect the selected question's required materials with the available materials.
Referenced methods: M03 §3.1, §3.2.1–3.2.4: principles for clarifying the question; detailed separation rules are Chamgap's own design; M03 §3.2.1; detailed population conditions are Chamgap's own design; M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap's own design

N24 · What was actually read of the stored summary, external papers/manuscripts and links?

Required materials and conditions: Full stored summary, PMID23391465/two reference URLs and unread external sources
Conditions for verification: Relevant original materials and the scope of analysis for Full stored summary, PMID23391465/two reference URLs and unread external sources must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Full stored summary, PMID23391465/two reference URLs and unread external sources and connect the selected question's required materials with the available materials.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N25 · How are existing Korean/English manuscripts, D34/axes, dates and empty values preserved?

Required materials and conditions: Subclaim D, parent D34, 2026-08-26, false/empty values and correction history
Conditions for verification: Relevant original materials and the scope of analysis for Subclaim D, parent D34, 2026-08-26, false/empty values and correction history must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Subclaim D, parent D34, 2026-08-26, false/empty values and correction history and connect the selected question's required materials with the available materials.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N26 · How are condition preservation/application, case preparation and content review distinguished?

Required materials and conditions: Records of condition preservation, freezing/application, case preparation and incomplete content review
Conditions for verification: Relevant original materials and the scope of analysis for Records of condition preservation, freezing/application, case preparation and incomplete content review must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: An item prepared to distinguish Records of condition preservation, freezing/application, case preparation and incomplete content review and connect the selected question's required materials with the available materials.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

What the statuses mean

Met: A state used when required evidence is confirmed after user review. This production does not declare that review complete.
Partly verified: Some information in the stored summary is linked into the table. External comparison/content review is not complete.
Unverified: The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
Review incomplete: User review pending.
Not reported: Not reported within the stored material actually read; not extended to the entire primary paper.
Inaccessible: Means an actual access failure. Access not attempted here is not assigned this state.
Not applicable: Not used as a substitute for an evidence gap.
Conflicting data: Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
Insufficient evidence for the conditions: Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

Change history

2026-10-10 · Public page/material version 1.0

The reader view and materials were prepared from the existing 26 items. No new clinical search, verification-status changes or scoring were performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · What are the subclaim and parent values for added protection after BCG?

Current findings: The selected existing question is 'added tuberculosis prevention after BCG', with D grade and the note 'There was no significant benefit'. Parent D34, Caution and original H/R1/I1/E0/B1/C0 axes are parent context; the subclaim has no score, status or axes.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but No new vaccine grade or score is created, and parent values are not inherited. Review of existing content remains incomplete.
Reason for missing information: No new vaccine grade or score is created, and parent values are not inherited.
Required materials and conditions: Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes.
Further research: A proposal for follow-up materials linking Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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N02 · Were participants studied before BCG vaccination or as already vaccinated infants?

Current findings: The original condition is a study of healthy infants who had all already received BCG. It is not extended to unvaccinated children, adults, other immune states or all infants.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Exact ages, location/exposure setting, inclusion/exclusion criteria and baseline immune/infection status remain unverified. Review of existing content remains incomplete.
Reason for missing information: Exact ages, location/exposure setting, inclusion/exclusion criteria and baseline immune/infection status remain unverified.
Required materials and conditions: Healthy, already vaccinated infants and the actual selection, age and setting boundaries
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Healthy, already vaccinated infants and the actual selection, age and setting boundaries.
Further research: A proposal for follow-up materials linking Healthy, already vaccinated infants and the actual selection, age and setting boundaries as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Healthy, already vaccinated infants and the actual selection, age and setting boundaries must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Healthy, already vaccinated infants and the actual selection, age and setting boundaries and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

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N03 · Are added MVA85A and the effect of BCG itself the same question?

Current findings: The original comparison is an MVA85A booster added after BCG versus placebo. It is not changed to efficacy of first BCG vaccination, an unvaccinated control, replacement of BCG or effects of all boosters.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Timing/type of BCG, booster interval/exposure, control composition and concomitant interventions remain unverified. Review of existing content remains incomplete.
Reason for missing information: Timing/type of BCG, booster interval/exposure, control composition and concomitant interventions remain unverified.
Required materials and conditions: BCG in both groups, the added candidate effect and comparison with placebo
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for BCG in both groups, the added candidate effect and comparison with placebo.
Further research: A proposal for follow-up materials linking BCG in both groups, the added candidate effect and comparison with placebo as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for BCG in both groups, the added candidate effect and comparison with placebo must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish BCG in both groups, the added candidate effect and comparison with placebo and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

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N04 · What research condition defines MVA85A?

Current findings: The existing research-product description states that MVA85A is a modified vaccinia Ankara vector expressing antigen 85A. This identity does not establish equivalence with existing BCG, other boosters or products, or provide vaccination/suitability guidance.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Original dose, route, number of doses, batch/quality, actual exposure and equivalence with other products remain unverified. Review of existing content remains incomplete.
Reason for missing information: Original dose, route, number of doses, batch/quality, actual exposure and equivalence with other products remain unverified.
Required materials and conditions: Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization.
Further research: A proposal for follow-up materials linking Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design

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N05 · What is known about allocation and assessment in the double-blind phase 2b design?

Current findings: The original study is a double-blind, placebo-controlled phase 2b RCT. The original B1 axis and double-blind label alone do not verify sequence generation, allocation concealment or blinding of all case assessments and follow-up.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Allocation/group ratio, placebo identity, assessor awareness and detailed case adjudication remain unverified. Review of existing content remains incomplete.
Reason for missing information: Allocation/group ratio, placebo identity, assessor awareness and detailed case adjudication remain unverified.
Required materials and conditions: Randomization/placebo, allocation concealment and tuberculosis case adjudication
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Randomization/placebo, allocation concealment and tuberculosis case adjudication.
Further research: A proposal for follow-up materials linking Randomization/placebo, allocation concealment and tuberculosis case adjudication as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Randomization/placebo, allocation concealment and tuberculosis case adjudication must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Randomization/placebo, allocation concealment and tuberculosis case adjudication and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

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N06 · How do 2797 participants differ from tuberculosis denominators 1399/1395?

Current findings: The original trial size of 2797 and tuberculosis results 32/1399 versus 39/1395 are preserved separately. Group denominators are not added or subtracted to calculate new missing/excluded counts or completion rates.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Randomized/analyzed counts by group, exclusions/losses/missing data and actual follow-up durations remain unverified. Review of existing content remains incomplete.
Reason for missing information: Randomized/analyzed counts by group, exclusions/losses/missing data and actual follow-up durations remain unverified.
Required materials and conditions: Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions.
Further research: A proposal for follow-up materials linking Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

Related sources S01

N07 · How were incident tuberculosis cases defined and adjudicated?

Current findings: The original endpoint is tuberculosis incidence. Definitions of active/confirmed/clinical tuberculosis, microbiological criteria and severity/site-specific results are not filled in from definitions absent from this summary.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Case criteria, testing/confirmation, adjudication/follow-up, components and recurrent events remain unverified. Review of existing content remains incomplete.
Reason for missing information: Case criteria, testing/confirmation, adjudication/follow-up, components and recurrent events remain unverified.
Required materials and conditions: Incident TB, clinical/test/severity definitions and case collection criteria
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Incident TB, clinical/test/severity definitions and case collection criteria.
Further research: A proposal for follow-up materials linking Incident TB, clinical/test/severity definitions and case collection criteria as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Incident TB, clinical/test/severity definitions and case collection criteria must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Incident TB, clinical/test/severity definitions and case collection criteria and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation to each question is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application

Related sources S01

N08 · Are tuberculosis disease, infection and immune response the same outcome?

Current findings: The quantitative result in the current stored summary is tuberculosis disease incidence. The summary is not presented as providing numerical results for infection incidence, test conversion or immune response/preventive effects.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. The currently required information remains unverified. Definitions, measurements, values/denominators/CIs and hierarchy of infection/immune endpoints remain unverified. Review of existing content remains incomplete.
Reason for missing information: Definitions, measurements, values/denominators/CIs and hierarchy of infection/immune endpoints remain unverified.
Required materials and conditions: Separate definitions/denominators for disease and infection/immune surrogate markers
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Separate definitions/denominators for disease and infection/immune surrogate markers.
Further research: A proposal for follow-up materials linking Separate definitions/denominators for disease and infection/immune surrogate markers as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Separate definitions/denominators for disease and infection/immune surrogate markers must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Separate definitions/denominators for disease and infection/immune surrogate markers and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension

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N09 · Does up to 37 months mean the same observation period for everyone?

Current findings: The existing research description states follow-up up to 37 months. This is not changed to 37-month completion by everyone, incidence over a fixed duration or lifelong prevention, and no new person-time or annualized rate is calculated.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Individual/group follow-up, median duration, censoring/missing data and first/recurrent disease rules remain unverified. Review of existing content remains incomplete.
Reason for missing information: Individual/group follow-up, median duration, censoring/missing data and first/recurrent disease rules remain unverified.
Required materials and conditions: Maximum follow-up, duration/censoring and first/recurrent event units
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Maximum follow-up, duration/censoring and first/recurrent event units.
Further research: A proposal for follow-up materials linking Maximum follow-up, duration/censoring and first/recurrent event units as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Maximum follow-up, duration/censoring and first/recurrent event units must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Maximum follow-up, duration/censoring and first/recurrent event units and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design

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N10 · Which groups do the tuberculosis fractions, proportions and absolute difference describe?

Current findings: Preserves original MVA85A 32/1399 (2.3%) versus control 39/1395 (2.8%), and absolute difference −.5%p. No new difference, incidence rate, NNT, absolute-difference CI or individual protection probability is calculated.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Exact denominators/analysis specification, absolute-difference CI, exposure/follow-up and models remain unverified. Review of existing content remains incomplete.
Reason for missing information: Exact denominators/analysis specification, absolute-difference CI, exposure/follow-up and models remain unverified.
Required materials and conditions: MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p.
Further research: A proposal for follow-up materials linking MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application

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N11 · What possibilities remain within the interval around vaccine efficacy 17.3%?

Current findings: The original Korean account states that vaccine efficacy 17.3% (95% CI −31.9~48.2) leaves possibilities in both benefit and harm directions. The finding of no significant benefit is not changed to an exact effect of 0, equivalence, exclusion of all important benefits or safety.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Efficacy model, covariates/censoring, original P value, importance threshold and subgroups remain unverified. Review of existing content remains incomplete.
Reason for missing information: Efficacy model, covariates/censoring, original P value, importance threshold and subgroups remain unverified.
Required materials and conditions: Original 17.3%, 95% CI −31.9~48.2, model and comparison direction
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Original 17.3%, 95% CI −31.9~48.2, model and comparison direction.
Further research: A proposal for follow-up materials linking Original 17.3%, 95% CI −31.9~48.2, model and comparison direction as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Original 17.3%, 95% CI −31.9~48.2, model and comparison direction must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Original 17.3%, 95% CI −31.9~48.2, model and comparison direction and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application

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N12 · How are the finding of no significant benefit or candidate success and the wide interval preserved together?

Current findings: The existing central summary/grade records no significant reduction in disease and D34. The interval −31.9~48.2 and wording allowing substantial benefit are also preserved, without a new significance, grade or overall vaccine-effect judgment.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Clinically important efficacy threshold, planned statistical power and exact P value/model remain unverified. Review of existing content remains incomplete.
Reason for missing information: Clinically important efficacy threshold, planned statistical power and exact P value/model remain unverified.
Required materials and conditions: Original D34/E0, no significant benefit and precision of the original CI
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Original D34/E0, no significant benefit and precision of the original CI.
Further research: A proposal for follow-up materials linking Original D34/E0, no significant benefit and precision of the original CI as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Original D34/E0, no significant benefit and precision of the original CI must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Original D34/E0, no significant benefit and precision of the original CI and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.6.3 and M15 §15.3.1–15.3.3; Status separation is Chamgap design; M15 §15.3.1–15.3.3; Chamgap application

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N13 · What prespecified analysis/endpoint specification applies to tuberculosis disease?

Current findings: The original is a large candidate vaccine trial of tuberculosis disease. Infection, immune responses, safety, other periods or subgroups are not promoted to the main efficacy outcome.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Registration/protocol/SAP, endpoint hierarchy/multiplicity and denominator/missing-data plans remain unverified. Review of existing content remains incomplete.
Reason for missing information: Registration/protocol/SAP, endpoint hierarchy/multiplicity and denominator/missing-data plans remain unverified.
Required materials and conditions: Original main disease time point, prespecified hierarchy, infection/safety and multiplicity
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Original main disease time point, prespecified hierarchy, infection/safety and multiplicity.
Further research: A proposal for follow-up materials linking Original main disease time point, prespecified hierarchy, infection/safety and multiplicity as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Original main disease time point, prespecified hierarchy, infection/safety and multiplicity must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Original main disease time point, prespecified hierarchy, infection/safety and multiplicity and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application

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N14 · How do actual exposure, BCG/concomitant interventions and follow-up measures relate to the added effect?

Current findings: The original comparison is an added candidate strategy after BCG in both groups. Actual MVA/control adherence, crossover, other vaccines, prevention/treatment or exposure differences are not newly filled in.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Actual exposures by group, concurrent measures/deviations, infection risks/treatment and event times remain unverified. Review of existing content remains incomplete.
Reason for missing information: Actual exposures by group, concurrent measures/deviations, infection risks/treatment and event times remain unverified.
Required materials and conditions: Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses.
Further research: A proposal for follow-up materials linking Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; design considerations in M19 §19.2.2–19.2.4; detailed confounding records are internally designed

Related sources S01

N15 · Are one trial, the parent/this sheet and different outcomes kept from becoming new independent counts?

Current findings: Tameris2013MVA85A020 is one existing clinical report. The parent disease judgment, this sheet, safety outcomes, repeated time points or groups are not added as new independent trials or total participants.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Unique clinical trial, participant and independent replication totals have not been verified and are not recorded. Review of existing content remains incomplete.
Reason for missing information: Unique clinical trial, participant and independent replication totals have not been verified and are not recorded.
Required materials and conditions: The same MVA85A020 trial, shared denominators/durations and added-effect question
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for The same MVA85A020 trial, shared denominators/durations and added-effect question.
Further research: A proposal for follow-up materials linking The same MVA85A020 trial, shared denominators/durations and added-effect question as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for The same MVA85A020 trial, shared denominators/durations and added-effect question must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish The same MVA85A020 trial, shared denominators/durations and added-effect question and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

Related sources S01

N16 · Is the 1245 first BCG vaccination manuscript a direct trial of an added booster?

Current findings: Existing cross-citation 1245 refers to a first BCG vaccination manuscript in unvaccinated children, B64. That manuscript/trial has not been read in this preparation and is not created as a direct trial or same-population replication of the added MVA effect.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but That original manuscript/trial, conditions/denominators and direct linkage remain unverified. Review of existing content remains incomplete.
Reason for missing information: That original manuscript/trial, conditions/denominators and direct linkage remain unverified.
Required materials and conditions: Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants.
Further research: A proposal for follow-up materials linking Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Question clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; M03 §3.2.1; detailed population conditions are internally designed

Related sources S02

N17 · Is the 2743 shortened pulmonary tuberculosis treatment reference a preventive vaccine result?

Current findings: Existing cross-citation 2743 refers to shortened treatment of established pulmonary tuberculosis, C56. The original title/relative URL is preserved, without changing it to a preventive effect, an independent vaccine trial or treatment guidance.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but That manuscript/trial has not been read and is not a direct result for a preventive booster. Review of existing content remains incomplete.
Reason for missing information: That manuscript/trial has not been read and is not a direct result for a preventive booster.
Required materials and conditions: Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention.
Further research: A proposal for follow-up materials linking Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Question clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptation are internally designed

Related sources S03

N18 · What are the Aeras/Wellcome/OETC relationships and commercial rights?

Current findings: Original funding names Aeras, Wellcome Trust and the Oxford-Emergent Tuberculosis Consortium. Oxford development and Emergent commercialization rights/consortium participation are preserved as the original history of mixed independence.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Specific support/products, employee authors, design/analysis/manuscript roles and COI/rights agreements have not been read in external sources. Review of existing content remains incomplete.
Reason for missing information: Specific support/products, employee authors, design/analysis/manuscript roles and COI/rights agreements have not been read in external sources.
Required materials and conditions: Nonprofit/development consortium, Oxford/Emergent relationships and actual roles
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Nonprofit/development consortium, Oxford/Emergent relationships and actual roles.
Further research: A proposal for follow-up materials linking Nonprofit/development consortium, Oxford/Emergent relationships and actual roles as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Nonprofit/development consortium, Oxford/Emergent relationships and actual roles must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Nonprofit/development consortium, Oxford/Emergent relationships and actual roles and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

Related sources S01

N19 · Do development rights and mixed funding verify all COI and product support?

Current findings: Original mixed funding and commercial development involvement are not expanded into new certification of product provision, all employee authors, all COI or absence of researcher independence. The original I1 axis is preserved as history.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Individual relationships, product/placebo support, data/publication authority and author contributions remain unverified. Review of existing content remains incomplete.
Reason for missing information: Individual relationships, product/placebo support, data/publication authority and author contributions remain unverified.
Required materials and conditions: Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority.
Further research: A proposal for follow-up materials linking Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

Related sources S01

N20 · Were the registration number and prespecified disease/infection plans actually read?

Current findings: Preserves original NCT00953927. The number/manuscript account alone does not establish actual reading of the registry, protocol or SAP, or fulfillment of prespecified disease/infection conditions.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Original registration/change history, endpoint definitions/denominators and multiplicity/missing-data plans have not been read. Review of existing content remains incomplete.
Reason for missing information: Original registration/change history, endpoint definitions/denominators and multiplicity/missing-data plans have not been read.
Required materials and conditions: NCT00953927 record, plans/change history, missing data and hierarchy
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for NCT00953927 record, plans/change history, missing data and hierarchy.
Further research: A proposal for follow-up materials linking NCT00953927 record, plans/change history, missing data and hierarchy as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for NCT00953927 record, plans/change history, missing data and hierarchy must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish NCT00953927 record, plans/change history, missing data and hierarchy and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

Related sources S01

N21 · What denominators and periods apply to local, systemic and serious adverse events?

Current findings: Preserves local events 89% versus 45%, systemic events 80% versus 76% and serious events 18% versus 18%. Differences, risk ratios, event counts or disease denominators are not newly calculated, and these results are not combined into one safety rate.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Each definition/collection process, people/events, groups/denominators, duration/recurrence and CI/P value remain unverified. Review of existing content remains incomplete.
Reason for missing information: Each definition/collection process, people/events, groups/denominators, duration/recurrence and CI/P value remain unverified.
Required materials and conditions: Distinct safety specifications for original 89/45%, 80/76% and 18/18%
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Distinct safety specifications for original 89/45%, 80/76% and 18/18%.
Further research: A proposal for follow-up materials linking Distinct safety specifications for original 89/45%, 80/76% and 18/18% as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Distinct safety specifications for original 89/45%, 80/76% and 18/18% must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Distinct safety specifications for original 89/45%, 80/76% and 18/18% and connect the selected question's required materials with the available materials.
Application exceptions: Addresses gaps in harm information for the selected recurrence/additional tuberculosis prevention question. Original efficacy, recurrence or safety wording is not used to judge overall safety or generate harm rates or guidance on antibiotic or vaccine selection, use or suitability.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4; internal application

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N22 · Does absence of related serious events mean zero risk or a vaccination recommendation?

Current findings: The original states that there were no related serious adverse events, while all serious events 18%/18% are separate. Wording about absence of related events is not changed to zero risk, safety of all vaccines/long-term use or a vaccination/suitability recommendation.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but Causality assessment/collection, exposure/loss to follow-up and rare, vulnerable-population or long-term harms remain unverified. Review of existing content remains incomplete.
Reason for missing information: Causality assessment/collection, exposure/loss to follow-up and rare, vulnerable-population or long-term harms remain unverified.
Required materials and conditions: Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms.
Further research: A proposal for follow-up materials linking Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms and connect the selected question's required materials with the available materials.
Application exceptions: Addresses gaps in harm information for the selected recurrence/additional tuberculosis prevention question. Original efficacy, recurrence or safety wording is not used to judge overall safety or generate harm rates or guidance on antibiotic or vaccine selection, use or suitability.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4; internal application; Chamgap's own interpretation boundary. Refers to M19 principles; no formal causality tool was applied.

Related sources S01

N23 · Can the result be generalized to BCG policy, other candidates/populations, prevention or treatment?

Current findings: This sheet contains historical original material on the added effect of that candidate. Original wording about Korean national BCG immunization is preserved in the full stored summary, without newly confirming current policy or creating guidance on vaccine selection, use, suitability, treatment or prevention.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but New confirmation of other boosters/populations/long-term outcomes and current policy is outside scope/unverified. Review of existing content remains incomplete.
Reason for missing information: New confirmation of other boosters/populations/long-term outcomes and current policy is outside scope/unverified.
Required materials and conditions: Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases.
Further research: A proposal for follow-up materials linking Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.1, §3.2.1–3.2.4: principles for clarifying the question; detailed separation rules are Chamgap's own design; M03 §3.2.1; detailed population conditions are Chamgap's own design; M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap's own design

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N24 · What was actually read of the stored summary, external papers/manuscripts and links?

Current findings: The full stored summary was read for preparation and labeled 'Summary read'. Original clinical-report and relative BCG/shortened-treatment URLs are preserved; external full papers/manuscripts, registration/plans and COI are labeled 'Not read'. Existing cross-citation checks are not inherited as current content review.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but External access, abstracts/full texts, link/click testing and comparison with original papers were not performed. Review of existing content remains incomplete.
Reason for missing information: External access, abstracts/full texts, link/click testing and comparison with original papers were not performed.
Required materials and conditions: Full stored summary, PMID23391465/two reference URLs and unread external sources
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Full stored summary, PMID23391465/two reference URLs and unread external sources.
Further research: A proposal for follow-up materials linking Full stored summary, PMID23391465/two reference URLs and unread external sources as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Full stored summary, PMID23391465/two reference URLs and unread external sources must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Full stored summary, PMID23391465/two reference URLs and unread external sources and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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N25 · How are existing Korean/English manuscripts, D34/axes, dates and empty values preserved?

Current findings: Preserves the full stored summary's Korean/English manuscripts, parent D34/Caution, original axes/false values, empty correction and deliberation records, and 2026-08-26. Absent subclaim D score, status or axes are not filled with parent values.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: This is a record from the stored summary. Some information exists in the stored summary, but The historical preparation records that translation, correction, reassessment, clinical original-paper review or external updating of the original judgment were not performed then. Review of existing content remains incomplete.
Reason for missing information: The historical preparation records that translation, correction, reassessment, clinical original-paper review or external updating of the original judgment were not performed then.
Required materials and conditions: Subclaim D, parent D34, 2026-08-26, false/empty values and correction history
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Subclaim D, parent D34, 2026-08-26, false/empty values and correction history.
Further research: A proposal for follow-up materials linking Subclaim D, parent D34, 2026-08-26, false/empty values and correction history as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Subclaim D, parent D34, 2026-08-26, false/empty values and correction history must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Subclaim D, parent D34, 2026-08-26, false/empty values and correction history and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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N26 · How are condition preservation/application, case preparation and content review distinguished?

Current findings: Condition preservation, freezing, application, case production and content review are separate records. Review of the existing content is incomplete; record counts are not totals of unique clinical trials/participants.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Record from the stored summary. Some information is in the stored summary. Review of the existing content is incomplete and clinical source material was not newly verified. Review of the existing content remains incomplete.
Reason for missing information: Review of the existing content is incomplete and clinical source material was not newly verified.
Required materials and conditions: Records of condition preservation, freezing/application, case preparation and incomplete content review
Materials to obtain first: Original definitions, result tables or planning materials, or user-provided copies, for Records of condition preservation, freezing/application, case preparation and incomplete content review.
Further research: A proposal for follow-up materials linking Records of condition preservation, freezing/application, case preparation and incomplete content review as a separate item; no new research, calculation or testing is performed in this preparation.
Remaining uncertainty: This preparation links preserved wording; it does not complete comparison with external original papers, an efficacy judgment or content review.
Conditions for verification: Relevant original materials and the scope of analysis for Records of condition preservation, freezing/application, case preparation and incomplete content review must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.
Why this condition is needed: An item prepared to distinguish Records of condition preservation, freezing/application, case preparation and incomplete content review and connect the selected question's required materials with the available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01 S02 S03