Developing World Study for RotaTeq™ (V260-015)(COMPLETED)

March 16, 2017 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7504

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 4 weeks through 12 weeks at Dose 1
  • Parent able to understand study procedures and give consent

Exclusion Criteria:

  • Clinical evidence of active gastrointestinal disease
  • Subjects who are currently or expected to participate in other studies of investigational products during the 6 weeks after receiving the last dose of RotaTeq™/placebo

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Biological: Comparator: Placebo
Arm 2: Placebo. 14 week treatment period
Experimental: 1
RotaTeq™
Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent
2.0 mL oral dose of RotaTeq™. 14 week treatment period
Other Names:
  • V260
  • RotaTeq™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose
Time Frame: At least 14 days following the third vaccination
At least 14 days following the third vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Time Frame: 14 days following the 3rd vaccination
Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)
14 days following the 3rd vaccination
Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Time Frame: 14 days following the 3rd vaccination
Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)
14 days following the 3rd vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 8, 2006

First Submitted That Met QC Criteria

August 9, 2006

First Posted (Estimate)

August 10, 2006

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V260-015
  • 2006_027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

CROs by country

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
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