Comparison · NCT00090233-98a1e126
RotaTeq™ vs Placebo: Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination
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. RotaTeq™ vs Placebo: Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination. Trial comparisons, record NCT00090233-98a1e126. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00090233-98a1e126
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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 | 0.0372 | 0.03 | 0.0459 | wilson | |
| Risk in group 2 | 0.137 | 0.123 | 0.151 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0995 | -0.116 | -0.0835 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.272 | 0.215 | 0.344 | log | |
| Odds ratio, group 1 over group 2 | 0.244 | 0.19 | 0.313 | log | |
| Number needed to treat, for one fewer participant with the outcome on RotaTeq™ than on Placebo | 10 | 8.64 | 12 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | RotaTeq™ | The number of participants randomized to treatment with RotaTeq™ is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range. | 82 | 2,207 | OG000 |
| Group 2 | Placebo | The number of participants randomized to treatment with Placebo is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range. | 315 | 2,305 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination
- Description
- Rotavirus gastroenteritis cases consist of all participants with one or more episodes classified as positive. Multiple positive episodes for one participant are counted as a single case.
- Time frame
- At least 14 days following the 3rd vaccination through the first full rotavirus season
- Population
- Per Protocol Population Using Per-Protocol Case Definition
Source ClinicalTrials.gov
Trial
- Title
- Rotavirus Efficacy and Safety Trial (REST)(V260-006)
- NCT number
- NCT00090233
- Phases
- PHASE3
- Conditions
- Rotavirus Infections
- Interventions
- Rotateq™, Comparator: Placebo
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2011-05-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00090233?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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