Comparison · NCT02968849-sae
Vaccine vs Placebo: serious adverse events
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. Vaccine vs Placebo: serious adverse events. Trial comparisons, record NCT02968849-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02968849-sae
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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 | 0.0381 | 0.0315 | 0.046 | wilson | |
| Risk in group 2 | 0.0352 | 0.0289 | 0.0428 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00291 | -0.00718 | 0.013 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 0.823 | 1.42 | log | |
| Odds ratio, group 1 over group 2 | 1.09 | 0.817 | 1.44 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Vaccine than on Placebo | 344 | 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 | Vaccine | ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18 | 103 | 2,704 | EG000 |
| Group 2 | Placebo | Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18 | 95 | 2,700 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Serious adverse events, adverse events of special interest, adverse events of STIs, new chronic medical conditions, and adverse events leading to early participant withdrawal or early discontinuation of study product(s) administration were collected through 12 months after the last vaccination received. All other adverse events were collected through 30 days after each vaccination.
Source ClinicalTrials.gov
Trial
- Title
- Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa
- NCT number
- NCT02968849
- Phases
- PHASE2, PHASE3
- Conditions
- HIV Infections
- Interventions
- ALVAC-HIV (vCP2438), Bivalent Subtype C gp120/MF59, Placebo
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2023-02-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02968849?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.govNone 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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