Primary Vaccination Group vs Booster Vaccination Group: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0298 | 0.026 | 0.0341 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0187 | 0.0146 | 0.0241 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.011 | 0.00449 | 0.017 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.59 | 1.19 | 2.12 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.61 | 1.2 | 2.15 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on Primary Vaccination Group than on Booster Vaccination Group | 90.6 | 58.7 | 223 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Primary Vaccination Group | Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination. | 204 | 6,851 | EG000 | ClinicalTrials.gov |
| Group 2 | Booster Vaccination Group | Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster. | 59 | 3,149 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Post-licensure Safety Study of IMOJEV® in Thailand | ClinicalTrials.gov |
| NCT number | NCT01981967 | ClinicalTrials.gov |
| Phases | PHASE4 | ClinicalTrials.gov |
| Conditions | Japanese Encephalitis | ClinicalTrials.gov |
| Interventions | IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine, IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine | ClinicalTrials.gov |
| Lead sponsor | Sanofi Pasteur, a Sanofi Company | ClinicalTrials.gov |
| Results first posted | 2016-05-04 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01981967?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.