Comparison · NCT04152161-17176240
Bacille Calmette Guerin (BCG) Group vs Placebo Group: Number of Participants With Serious Adverse Events (SAEs)
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. Bacille Calmette Guerin (BCG) Group vs Placebo Group: Number of Participants With Serious Adverse Events (SAEs). Trial comparisons, record NCT04152161-17176240. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04152161-17176240
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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 | 0.00327 | 0.00111 | 0.00956 | wilson | |
| Risk in group 2 | 0.00327 | 0.00111 | 0.00957 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00000356 | -0.00666 | 0.00665 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.999 | 0.202 | 4.94 | log | |
| Odds ratio, group 1 over group 2 | 0.999 | 0.201 | 4.96 | log | |
| Number needed to treat, for one fewer participant with the outcome on Bacille Calmette Guerin (BCG) Group than on Placebo Group | 281,000 | 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. | 3 | 918 | OG000 |
| 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. | 3 | 917 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Serious Adverse Events (SAEs)
- Description
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of Participants reporting SAEs has been presented.
- Time frame
- Up to 6 months
- Population
- Safety Population
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.
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