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Comparison · NCT01755598-deaths

M72AS01 Group vs Control Group: deaths from any cause

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. M72AS01 Group vs Control Group: deaths from any cause. Trial comparisons, record NCT01755598-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01755598-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.01060.006820.0166wilson
Risk in group 20.01570.01090.0226wilson
Risk difference, group 1 minus group 2-0.00503-0.01290.00259newcombe hybrid score
Risk ratio, group 1 over group 20.6790.3811.21log
Odds ratio, group 1 over group 20.6750.3761.21log
Number needed to treat, for one fewer death from any cause on M72AS01 Group than on Control Group199from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: control.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1M72AS01 Group
Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
191,786EG000
Group 2Control Group
Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
281,787EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Solicited local and general symptoms were reported during the 7-day (Days 0-6) post-vaccination period and unsolicited AE(s): during the 30-day (Days 0-29) post-vaccination period. SAE(s): were reported during the entire study period (from Month 0 to Month 36 (Year 3).

Source ClinicalTrials.gov

Trial

Title
Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults
NCT number
NCT01755598
Phases
PHASE2
Conditions
Tuberculosis, Tuberculosis Vaccines
Interventions
GSK Biologicals' investigational TB vaccine (GSK692342), Placebo
Lead sponsor
GlaxoSmithKline
Results first posted
2019-12-03

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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