RotaTeq™ vs Placebo: Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo
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 | 0.000176 | 0.0000809 | 0.000385 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.000147 | 0.0000629 | 0.000345 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.0000293 | -0.00019 | 0.000254 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.2 | 0.366 | 3.93 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.2 | 0.366 | 3.93 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on RotaTeq™ than on Placebo | 34,200 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | RotaTeq™ | Three oral doses (\~6.5x10\^7 to \~1.2x10\^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart. | 6 | 34,002 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart. | 5 | 33,969 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo | ClinicalTrials.gov |
| Description | Number of participants with confirmed intussusception within 42 days after each vaccination with RotaTeq™/placebo. | ClinicalTrials.gov |
| Time frame | Within 42 days following any dose of RotaTeq™/placebo | ClinicalTrials.gov |
| Population | All participants in the study were followed for potential cases of intussusception. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Rotavirus Efficacy and Safety Trial (REST)(V260-006) | ClinicalTrials.gov |
| NCT number | NCT00090233 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Rotavirus Infections | ClinicalTrials.gov |
| Interventions | Rotateq™, Comparator: Placebo | ClinicalTrials.gov |
| Lead sponsor | Merck Sharp & Dohme LLC | ClinicalTrials.gov |
| Results first posted | 2011-05-05 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00090233?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.