A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)

October 8, 2015 updated by: Merck Sharp & Dohme LLC

A Randomized, Open-Label Clinical Study to Assess the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine When Administered Concomitantly With RotaTeq™ or Rotarix™ in Healthy Infants in South Africa

This study will evaluate the immunogenicity and safety of the pertussis component of DTwP (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or Rotatrix™.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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:

  • Healthy infants

Exclusion Criteria:

  • History of abdominal disorders, intestinal folding, or abdominal surgery
  • Impaired immune system
  • Prior administration of any rotavirus vaccine or DTwP/DTaP
  • Fever of >= 38.1C (100.5F) at the time of vaccination
  • History of prior rotavirus infection, chronic diarrhea, or failure to thrive
  • Evidence of active gastrointestinal illness

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
RotaTeq™ + DTwP
Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
[Intervention name: RotaTeq™ administered concomitantly with Tritanrix™ HepB (DTwP)] Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration.
Active Comparator: 2
Rotarix™ + DTwP
Biological: Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)
Two 1.0 mL oral doses of Rotarix™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration (the second administration will be Tritanrix™ HepB only).
Active Comparator: 3
RotaTeq™ + DTaP
Biological: Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)
Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of INFANRIX™ will be given at the same time with about 1 month between each administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Geometric Mean Titer (GMT) for Pertussis Toxoid
Time Frame: 1 month post dose 3
1 month post dose 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Geometric Mean Titer (GMT) for rotavirus serotypes G1, G2, G3, G4 and P1A
Time Frame: 1 month post dose 3
1 month post dose 3

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

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

December 1, 2009

Primary Completion (Anticipated)

August 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

October 27, 2009

First Submitted That Met QC Criteria

October 27, 2009

First Posted (Estimate)

October 28, 2009

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 8, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V260-036

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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