A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine

September 8, 2016 updated by: GlaxoSmithKline

A Phase III, Observer-blinded Randomised, Multi-centre Clinical Study of the Safety, Immunogenicity and Consistency of Three Manufacturing Lots of GSK Biologicals' Candidate Tdap Vaccine as Compared to a US-licensed Td Vaccine When Given as a Booster Dose to Healthy Adolescents (10-18 Years of Age)

This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of age).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A combined Tdap (Tetanus, Diphteria, Acellular Pertussis) Vaccine Used as a Booster compared to Licensed Td (Tetanus and Diphteria) vaccine

Study Type

Interventional

Enrollment (Actual)

4116

Phase

  • Phase 3

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
    • Arizona
      • Mesa, Arizona, United States, 85201
        • GSK Investigational Site
      • Tempe, Arizona, United States, 85282
        • GSK Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • GSK Investigational Site
      • Little Rock, Arkansas, United States, 72202
        • GSK Investigational Site
    • California
      • Escondido, California, United States, 92021
        • GSK Investigational Site
      • Fullerton, California, United States, 92835
        • GSK Investigational Site
      • Redondo Beach, California, United States, 90277
        • GSK Investigational Site
      • Rolling Hills Est, California, United States, 90274
        • GSK Investigational Site
      • Torrance, California, United States, 90502
        • GSK Investigational Site
      • Yorba Linda, California, United States, 92886
        • GSK Investigational Site
    • Colorado
      • Boulder, Colorado, United States, 80304
        • GSK Investigational Site
      • Centennial, Colorado, United States, 80112
        • GSK Investigational Site
      • Golden, Colorado, United States, 80401
        • GSK Investigational Site
    • Connecticut
      • Middletown, Connecticut, United States, 06457
        • GSK Investigational Site
      • Norwich, Connecticut, United States, 06360
        • GSK Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32209
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60614
        • GSK Investigational Site
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • GSK Investigational Site
    • Maine
      • New Bedford, Maine, United States, 2740
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • GSK Investigational Site
      • Boston, Massachusetts, United States, 02130
        • GSK Investigational Site
      • Milford, Massachusetts, United States, 01757
        • GSK Investigational Site
      • Woburn, Massachusetts, United States, 01801
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68178
        • GSK Investigational Site
    • New Jersey
      • Whitehouse Station, New Jersey, United States, 08889
        • GSK Investigational Site
    • New York
      • Rochester, New York, United States, 14620
        • GSK Investigational Site
      • Stony Brook, New York, United States, 11794
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • GSK Investigational Site
      • Durham, North Carolina, United States, 27710
        • GSK Investigational Site
      • Lumberton, North Carolina, United States, 28358
        • GSK Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44308-1062
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44109
        • GSK Investigational Site
      • University Heights, Ohio, United States, 44118
        • GSK Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213-2583
        • GSK Investigational Site
      • Sellersville, Pennsylvania, United States, 18960
        • GSK Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • GSK Investigational Site
    • Texas
      • Bryan, Texas, United States, 77802
        • GSK Investigational Site
      • Georgetown, Texas, United States, 78626
        • GSK Investigational Site
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
      • Temple, Texas, United States, 76508
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • GSK Investigational Site
      • West Jordan, Utah, United States, 84084
        • GSK Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • 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

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adolescents with history of completed routine vaccination against diphtheria, tetanus, and pertussis (DTP).

Exclusion Criteria:

  • Use of any other investigational drug or vaccine 30 days preceding study vaccination.
  • Chronic administration of immunosuppressants.
  • Administration of pre-school DTP vaccine within previous 5 years.
  • Administration of Td booster within previous 10 years.

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: Single

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.

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)

April 1, 2004

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

April 27, 2005

First Submitted That Met QC Criteria

April 26, 2005

First Posted (Estimate)

April 27, 2005

Study Record Updates

Last Update Posted (Estimate)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 776423/001

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. Statistical Analysis Plan
    Information identifier: 776423/001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: 776423/001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Informed Consent Form
    Information identifier: 776423/001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individual Participant Data Set
    Information identifier: 776423/001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: 776423/001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: 776423/001
    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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