CYD Dengue Vaccine Group vs Placebo 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 | 0.138 | 0.13 | 0.147 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.161 | 0.149 | 0.174 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0229 | -0.0379 | -0.00834 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.858 | 0.779 | 0.945 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.835 | 0.745 | 0.936 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with a serious adverse event on CYD Dengue Vaccine Group than on Placebo Group | 43.6 | 26.4 | 120 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | CYD Dengue Vaccine Group | Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months. | 947 | 6,848 | EG000 | ClinicalTrials.gov |
| Group 2 | Placebo Group | Participants were to receive 3 doses of placebo vaccine; one each at 0, 6, and 12 months. | 552 | 3,424 | 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 months post-injection 3 (up to 72 months). | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Study of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia | ClinicalTrials.gov |
| NCT number | NCT01373281 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Dengue, Dengue Fever, Dengue Hemorrhagic Fever | ClinicalTrials.gov |
| Interventions | Live, attenuated, dengue serotype 1, 2, 3, 4 virus, Placebo: Sodium chloride (NaCl) 0.9% | ClinicalTrials.gov |
| Lead sponsor | Sanofi Pasteur, a Sanofi Company | ClinicalTrials.gov |
| Results first posted | 2015-11-16 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01373281?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.