CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,312 enrolled
Drug / intervention
RotaTeq™, rotavirus vaccine, live, oral, pentavalent +1 morebiological
Likely dose
RotaTeq (pentavalent rotavirus vaccine, live, oral) — three doses administered 28 to 70 days apartAI-extracted
Key inclusion· 1
  • ✓Healthy infants
Key exclusion· 6
  • ✕History of abdominal disorders from birth defect, intussusception, or abdominal surgery
  • ✕Known or suspected immune system problems
  • ✕Fever at time of immunization
  • ✕Prior rotavirus vaccine administration

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00092443
NCT00092443Phase 3Completed
CompareCT.gov

Study of the Efficacy, Safety, and Immunogenicity of V260 at Expiry

Merck Sharp & Dohme LLC·interventional·Posted Sep 27, 2004·Updated Sep 14, 2015

In Brief

A Phase 3 clinical trial evaluating RotaTeq™, rotavirus vaccine, live, oral, pentavalent and Comparator: Placebo matching RotaTeq™ for Rotavirus Infections. Completed, enrolled 1,312 participants.

Detailed Summary

This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRotavirus Infections
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 27, 2004
Enrollment StartSep 1, 2002
Primary CompletionJun 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 21.8 years ago

Interventions

RotaTeq™, rotavirus vaccine, live, oral, pentavalentbiological

Three doses of RotaTeq™ administered 28 to 70 days apart.

Comparator: Placebo matching RotaTeq™biological

Placebo matching RotaTeq™ administered 28 to 70 days apart.