Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)

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

Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq (V260) in Healthy Infants in India

To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

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

1 month to 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 6 weeks through exactly 12 weeks
  • Healthy infants

Exclusion Criteria:

  • Clinical evidence of active gastrointestinal illness
  • Fever, with a rectal temperature of greater than and equal to thirty eight degree celsius at the time of immunization
  • History of congenital abdominal disorders, intussusception, or abdominal surgery
  • History of known prior rotavirus disease
  • Known or suspected impairment of immunological function
  • Prior administration of any rotavirus vaccine
  • Known hypersensitivity to any component of the rotavirus vaccine, e.g. trypsin

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RotaTeq™ Vaccine (V260)
Evaluation of Safety, Tolerability and Immunogenicity of Vaccination with RotaTeq™ in Healthy Infants in India.
Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Pentavalent vaccine 9G1, G2, G3, G4 & P1) given 3 times. Dose 1 will be administered at study entry; Dose 2 will be administered 4 to 10 weeks (28 to 70 days) after Dose 1; and Dose 3 will be administered 4 to 10 weeks (28 to 70 days) after Dose 2.
Other Names:
  • V260
  • RotaTeq™ Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA
Time Frame: Baseline and Approximately 6 Months
Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)
Time Frame: Baseline and Approximately 6 Months
Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)
Time Frame: Baseline and Approximately 6 Months
Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)
Time Frame: Baseline and Approximately 6 Months
Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)
Time Frame: Baseline and Approximately 6 Months
Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)
Time Frame: Baseline and Approximately 6 Months
Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)
Time Frame: Baseline and Approximately 6 Months
Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA
Time Frame: Baseline and Approximately 6 Months
Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1
Time Frame: Baseline and Approximately 6 Months
Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2
Time Frame: Baseline and Approximately 6 Months
Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3
Time Frame: Baseline and Approximately 6 Months
Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4
Time Frame: Baseline and Approximately 6 Months
Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1
Time Frame: Baseline and Approximately 6 Months
Baseline and Approximately 6 Months

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

May 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

July 3, 2007

First Submitted That Met QC Criteria

July 3, 2007

First Posted (Estimate)

July 4, 2007

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

  • V260-021
  • 2007_020

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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