Comparison · NCT00092443-sae
RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) vs Placebo Matching RotaTeq™: 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. RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) vs Placebo Matching RotaTeq™: serious adverse events. Trial comparisons, record NCT00092443-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00092443-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 | 0.0324 | 0.0213 | 0.049 | wilson | |
| Risk in group 2 | 0.0426 | 0.0296 | 0.0608 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0102 | -0.0316 | 0.0109 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.76 | 0.436 | 1.32 | log | |
| Odds ratio, group 1 over group 2 | 0.752 | 0.423 | 1.34 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) than on Placebo Matching RotaTeq™ | 98.1 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination. | 21 | 649 | EG000 |
| Group 2 | Placebo Matching RotaTeq™ | Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination. | 28 | 658 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Dose Confirmation Efficacy Study (V260-007)
- NCT number
- NCT00092443
- Phases
- PHASE3
- Conditions
- Rotavirus Infections
- Interventions
- RotaTeq™, rotavirus vaccine, live, oral, pentavalent, Comparator: Placebo matching RotaTeq™
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2009-07-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00092443?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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