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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00109330
Other study ID # 776423/001
Secondary ID
Status Completed
Phase Phase 3
First received April 27, 2005
Last updated September 8, 2016
Start date November 2002
Est. completion date April 2004

Study information

Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 4116
Est. completion date April 2004
Est. primary completion date April 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 10 Years to 18 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Combined diphtheria, tetanus, acellular pertussis vaccine


Locations

Country Name City State
United States GSK Investigational Site Akron Ohio
United States GSK Investigational Site Bardstown Kentucky
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Boulder Colorado
United States GSK Investigational Site Bryan Texas
United States GSK Investigational Site Centennial Colorado
United States GSK Investigational Site Chapel Hill North Carolina
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Cleveland Ohio
United States GSK Investigational Site Durham North Carolina
United States GSK Investigational Site Escondido California
United States GSK Investigational Site Fullerton California
United States GSK Investigational Site Georgetown Texas
United States GSK Investigational Site Golden Colorado
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Jacksonville Florida
United States GSK Investigational Site Jonesboro Arkansas
United States GSK Investigational Site Kingsport Tennessee
United States GSK Investigational Site Little Rock Arkansas
United States GSK Investigational Site Lumberton North Carolina
United States GSK Investigational Site Mesa Arizona
United States GSK Investigational Site Middletown Connecticut
United States GSK Investigational Site Milford Massachusetts
United States GSK Investigational Site New Bedford Maine
United States GSK Investigational Site Norfolk Virginia
United States GSK Investigational Site Norwich Connecticut
United States GSK Investigational Site Omaha Nebraska
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Redondo Beach California
United States GSK Investigational Site Rochester New York
United States GSK Investigational Site Rolling Hills Est California
United States GSK Investigational Site Salt Lake City Utah
United States GSK Investigational Site Sellersville Pennsylvania
United States GSK Investigational Site Stony Brook New York
United States GSK Investigational Site Tempe Arizona
United States GSK Investigational Site Temple Texas
United States GSK Investigational Site Torrance California
United States GSK Investigational Site University Heights Ohio
United States GSK Investigational Site West Jordan Utah
United States GSK Investigational Site Whitehouse Station New Jersey
United States GSK Investigational Site Woburn Massachusetts
United States GSK Investigational Site Yorba Linda California

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

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