Comparison · NCT01755598-d91081c2
M72AS01 Group vs Control Group: Number of Subjects With Any Unsolicited Adverse Events (AEs).
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: Number of Subjects With Any Unsolicited Adverse Events (AEs). Trial comparisons, record NCT01755598-d91081c2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01755598-d91081c2
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.676 | 0.654 | 0.697 | wilson | |
| Risk in group 2 | 0.457 | 0.434 | 0.48 | wilson | |
| Risk difference, group 1 minus group 2 | 0.219 | 0.187 | 0.251 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.48 | 1.39 | 1.57 | log | |
| Odds ratio, group 1 over group 2 | 2.48 | 2.17 | 2.84 | log | |
| Number needed to treat, for one more participant with the outcome on M72AS01 Group than on Control Group | 4.56 | 3.99 | 5.34 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | M72AS01 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. | 1,207 | 1,786 | OG000 |
| Group 2 | Control 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. | 816 | 1,787 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Subjects With Any Unsolicited Adverse Events (AEs).
- Description
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
- Time frame
- During the 30-day follow-up period following vaccination, across doses (i.e. day of vaccination and 29 subsequent days after each vaccine dose)
- Population
- Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose administered.
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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01755598?tab=results
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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