Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety

September 14, 2016 updated by: GlaxoSmithKline

Open, Randomized, Phase II, Clinical Trial to Compare the Immunogenicity and Safety of a Booster Dose of GSK Biologicals' DTaP-IPV Vaccine (Infanrix®-IPV) Co-administered With a Booster Dose of Merck and Company's M-M-R®II, to That of Separate Injections of GSK Biologicals' DTaP Vaccine (Infanrix®), Aventis Pasteur's IPV (IPOL®) and M-M-R®II Administered as Booster Doses to Healthy Children 4 to 6 Years of Age.

The aims of this study are to compare the immunogenicity and safety of the GSK Biologicals' combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years when co-administered with MMR vaccine in subjects who had previously received four doses of Infanrix, three doses of poliovirus-containing vaccine and MMR vaccination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

401

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • GSK Investigational Site
    • California
      • Fountain Valley, California, United States, 92708
        • GSK Investigational Site
      • Oakland, California, United States, 94612
        • GSK Investigational Site
      • Torrance, California, United States, 90502
        • GSK Investigational Site
    • Georgia
      • Marietta, Georgia, United States, 30062
        • GSK Investigational Site
      • Woodstock, Georgia, United States, 30188
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60614
        • GSK Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70128
        • GSK Investigational Site
      • Ruston, Louisiana, United States, 71270
        • GSK Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • GSK Investigational Site
      • Whitehouse Station, New Jersey, United States, 08889
        • GSK Investigational Site
    • New York
      • Endwell, New York, United States, 13760
        • GSK Investigational Site
      • Stony Brook, New York, United States, 11794
        • GSK Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • GSK Investigational Site
    • Virginia
      • Mechanicsville, Virginia, United States, 23111
        • GSK Investigational Site

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 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy children between and including 4 and 6 years of age.
  • Previously received 4 doses of GSK Biologicals' DTaP, 3 doses of IPV vaccine and 1 dose of measles, mumps, and rubella vaccine.

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
  • Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period
  • Administration of immunoglobulins and/or blood products within 3 months prior to vaccination.

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: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Immunogenicity after vaccination.

Secondary Outcome Measures

Outcome Measure
Immunogenicity and safety after vaccination.

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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

Helpful Links

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

November 1, 2002

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

December 8, 2005

First Submitted That Met QC Criteria

December 8, 2005

First Posted (Estimate)

December 9, 2005

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 213503/047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Clinical Study Report
    Information identifier: 213503/047
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informed Consent Form
    Information identifier: 213503/047
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Dataset Specification
    Information identifier: 213503/047
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: 213503/047
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Study Protocol
    Information identifier: 213503/047
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: 213503/047
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

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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