Comparison · NCT01854632-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 NCT01854632-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01854632-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 | 0.00596 | 0.00289 | 0.0123 | wilson | |
| Risk in group 2 | 0.0119 | 0.00579 | 0.0244 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00596 | -0.0188 | 0.00283 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.5 | 0.176 | 1.42 | log | |
| Odds ratio, group 1 over group 2 | 0.497 | 0.174 | 1.42 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Vaccine than on Placebo | 168 | 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 | Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 | 7 | 1,174 | EG000 |
| Group 2 | Placebo | Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid. | 7 | 587 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Throughout the study period: May through December 2013
Source ClinicalTrials.gov
Trial
- Title
- Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal
- NCT number
- NCT01854632
- Phases
- PHASE3
- Conditions
- Influenza
- Interventions
- SIIL Live Attenuated Influenza Vaccine, Matched placebo
- Lead sponsor
- PATH
- Results first posted
- 2015-06-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01854632?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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