RotaTeq™ vs Placebo: serious adverse events

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	Source
Risk in group 1	0.0247	0.0231	0.0264	wilson	ClinicalTrials.gov
Risk in group 2	0.0274	0.0257	0.0292	wilson	ClinicalTrials.gov
Risk difference, group 1 minus group 2	-0.00267	-0.00504	-0.000304	newcombe hybrid score	ClinicalTrials.gov
Risk ratio, group 1 over group 2	0.903	0.824	0.988	log	ClinicalTrials.gov
Odds ratio, group 1 over group 2	0.9	0.82	0.988	log	ClinicalTrials.gov
Number needed to treat, for one fewer participant with a serious adverse event on RotaTeq™ than on Placebo	375	199	3,290	from the risk difference interval	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.~The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3.	863	34,904	EG000	ClinicalTrials.gov
Group 2	Placebo	Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.~The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3.	955	34,862	EG001	ClinicalTrials.gov

Harm 2

Field	Value	Source
What it counts	Total, serious adverse events	ClinicalTrials.gov
Time frame	Participants in this study were followed for all serious adverse events (SAEs) and other adverse events (AEs), for up to 42 days following each study vaccination	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

The same record as JSON

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.