Comparison · NCT04152161-deaths
Bacille Calmette Guerin (BCG) Group vs Placebo 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
Cite this record
ConductScience Library. Bacille Calmette Guerin (BCG) Group vs Placebo Group: deaths from any cause. Trial comparisons, record NCT04152161-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04152161-deaths
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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 | 0 | 0.00417 | wilson | |
| Risk in group 2 | 0.00109 | 0.000193 | 0.00615 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00109 | -0.00615 | 0.00317 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer death from any cause on Bacille Calmette Guerin (BCG) Group than on Placebo Group | 917 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Bacille Calmette Guerin (BCG) Group | Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm. | 0 | 918 | EG000 |
| Group 2 | Placebo Group | Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm. | 1 | 917 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48.
Source ClinicalTrials.gov
Trial
- Title
- Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection
- NCT number
- NCT04152161
- Phases
- PHASE2
- Conditions
- Tuberculosis
- Interventions
- BCG vaccine SSI, Placebo
- Lead sponsor
- Gates Medical Research Institute
- Results first posted
- 2025-06-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04152161?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.
For software
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