Comparison · NCT02062385-sae
V260 With Staggered or Concomitant EPI vs Placebo With Staggered or Concomitant EPI: 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. V260 With Staggered or Concomitant EPI vs Placebo With Staggered or Concomitant EPI: serious adverse events. Trial comparisons, record NCT02062385-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02062385-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 | 0.168 | 0.153 | 0.185 | wilson | |
| Risk in group 2 | 0.167 | 0.152 | 0.184 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000829 | -0.0222 | 0.0239 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.876 | 1.15 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.853 | 1.19 | log | |
| Number needed to harm, for one more participant with a serious adverse event on V260 With Staggered or Concomitant EPI than on Placebo With Staggered or Concomitant EPI | 1,210 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
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 |
|---|---|---|---|---|---|
| Group 1 | V260 With Staggered or Concomitant EPI | V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months. | 339 | 2,015 | EG000 |
| Group 2 | Placebo With Staggered or Concomitant EPI | Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months. | 338 | 2,019 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All Adverse Events: up to 30 days after any V260 or placebo vaccination; Serious Adverse Events: from the time of written consent until the end of the study (up to 15 months)
Source ClinicalTrials.gov
Trial
- Title
- Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)
- NCT number
- NCT02062385
- Phases
- PHASE3
- Conditions
- Rotavirus Gastroenteritis
- Interventions
- V260, Placebo to V260, OPV, DTaP
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2016-04-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02062385?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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