Comparison · NCT01340937-sae
V419 Lots A, B, and C Combined vs Control: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. V419 Lots A, B, and C Combined vs Control: serious adverse events. Trial comparisons, record NCT01340937-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01340937-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 | 0.0393 | 0.0322 | 0.0479 | wilson | |
| Risk in group 2 | 0.0378 | 0.023 | 0.0614 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00155 | -0.0231 | 0.0186 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.61 | 1.78 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.598 | 1.82 | log | |
| Number needed to harm, for one more participant with a serious adverse event on V419 Lots A, B, and C Combined than on Control | 646 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | V419 Lots A, B, and C Combined | V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age. | 94 | 2,390 | EG000 |
| Group 2 | Control | Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age. | 15 | 397 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
Source ClinicalTrials.gov
Trial
- Title
- A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)
- NCT number
- NCT01340937
- Phases
- PHASE3
- Conditions
- Bacterial Infections, Virus Diseases
- Interventions
- V419, PENTACEL™, Prevnar 13™, RotaTeq™, Recombivax HB vaccine
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2016-05-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01340937?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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