Completed

Safety and Efficacy of Pentavalent (G1, G2, G3, G4 , and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants

What is being tested

Rotateq™

+ Comparator: Placebo

Biological

Who is being recruted

Infections+2

+ Reoviridae Infections

+ RNA Virus Infections

See all eligibility criteria

How is the trial designed

Prevention Study

Placebo-ControlledPhase 3

Interventional

Study Start: January 2001

See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC

Last updated: December 11, 2025

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2001

Actual date on which the first participant was enrolled.

This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.

Official TitleSafety and Efficacy of Pentavalent (G1, G2, G3, G4 , and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants

NCT00090233

Principal SponsorMerck Sharp & Dohme LLC

Last updated: December 11, 2025

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

69274 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsReoviridae InfectionsRNA Virus InfectionsRotavirus InfectionsVirus Diseases

Criteria

Inclusion Criteria: * Healthy infants Exclusion Criteria: * None Specified

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

RotaTeq

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

CompletedNo study centers