Comparison · NCT04152161-b3eb844d
Bacille Calmette Guerin (BCG) Group vs Placebo Group: Number of Participants With Unsolicited AEs Through Day 28, as Well as Solicited AEs That Were Ongoing at Day 7 After Vaccination
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 Unsolicited AEs Through Day 28, as Well as Solicited AEs That Were Ongoing at Day 7 After Vaccination. Trial comparisons, record NCT04152161-b3eb844d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04152161-b3eb844d
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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 | 0.202 | 0.177 | 0.229 | wilson | |
| Risk in group 2 | 0.128 | 0.108 | 0.151 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0739 | 0.0401 | 0.108 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.58 | 1.28 | 1.95 | log | |
| Odds ratio, group 1 over group 2 | 1.73 | 1.34 | 2.22 | log | |
| Number needed to treat, for one more participant with the outcome on Bacille Calmette Guerin (BCG) Group than on Placebo Group | 13.5 | 9.28 | 24.9 | from the risk difference interval |
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. | 185 | 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. | 117 | 917 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Unsolicited AEs Through Day 28, as Well as Solicited AEs That Were Ongoing at Day 7 After Vaccination
- 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 AE does not necessarily have a causal relationship with the intervention. Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary card, as well as solicited AEs that were ongoing at Day 7 after vaccination. Number of Participants With Unsolicited AEs Through 28 Days after vaccination has been presented.
- Time frame
- Day 1 through Day 28
- 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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