CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 7,504 enrolled
Drug / intervention
RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent +1 morebiological
Likely dose
RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent 2.0 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00362648
NCT00362648Phase 3Completed
CompareCT.gov

Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa

Merck Sharp & Dohme LLC·interventional·Posted Aug 10, 2006·Updated Apr 13, 2017

In Brief

A Phase 3 clinical trial evaluating RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent and Comparator: Placebo for Vomiting and 2 related conditions. Completed, enrolled 7,504 participants.

Detailed Summary

The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVomiting, Diarrhea, Fever
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 10, 2006
Enrollment StartMar 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19.9 years ago

Interventions

RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalentbiological

2.0 mL oral dose of RotaTeq™. 14 week treatment period

Comparator: Placebobiological

Arm 2: Placebo. 14 week treatment period