Comparison · NCT01797029-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 NCT01797029-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01797029-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 | 0.0358 | 0.0266 | 0.048 | wilson | |
| Risk in group 2 | 0.0324 | 0.0208 | 0.05 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00341 | -0.0165 | 0.0202 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.11 | 0.649 | 1.88 | log | |
| Odds ratio, group 1 over group 2 | 1.11 | 0.639 | 1.92 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Vaccine than on Placebo | 293 | 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 | A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 | 42 | 1,174 | EG000 |
| Group 2 | Placebo | Inactive 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. | 19 | 587 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Throughout study period: February 2013 to September 2014, up to 20 months of follow-up.
Source ClinicalTrials.gov
Trial
- Title
- A Randomized, Controlled Trial on the Efficacy and Safety of Live-Attenuated Influenza Vaccine (LAIV) Among Children in Bangladesh
- NCT number
- NCT01797029
- Phases
- PHASE3
- Conditions
- Influenza
- Interventions
- SIIL Live Attenuated Influenza Vaccine, Placebo
- Lead sponsor
- PATH
- Results first posted
- 2015-05-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01797029?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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