A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine - Full Text View

Purpose

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).

Condition	Intervention	Phase
Diphtheria Pertussis Tetanus	Biological: Combined diphtheria, tetanus, acellular pertussis vaccine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention
Official Title:	A Phase III, Observer-blinded Randomised, Multi-centre Clinical Study of the Safety, Immunogenicity and Consistency of Three Manufacturing Lots of GSK Bios' 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)

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Enrollment:	4116
Study Start Date:	November 2002
Study Completion Date:	April 2004
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Detailed Description:

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

Eligibility

Ages Eligible for Study:	10 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109330

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Locations

United States, Arizona
GSK Investigational Site
Mesa, Arizona, United States, 85201
GSK Investigational Site
Tempe, Arizona, United States, 85282
United States, Arkansas
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
GSK Investigational Site
Little Rock, Arkansas, United States, 72202
United States, California
GSK Investigational Site
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
United States, Colorado
GSK Investigational Site
Boulder, Colorado, United States, 80304
GSK Investigational Site
Centennial, Colorado, United States, 80112
GSK Investigational Site
Golden, Colorado, United States, 80401
United States, Connecticut
GSK Investigational Site
Middletown, Connecticut, United States, 06457
GSK Investigational Site
Norwich, Connecticut, United States, 06360
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32209
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60614
United States, Kentucky
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02130
GSK Investigational Site
Boston, Massachusetts, United States, 02115
GSK Investigational Site
Milford, Massachusetts, United States, 01757
GSK Investigational Site
Woburn, Massachusetts, United States, 01801
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68178
United States, New Jersey
GSK Investigational Site
Whitehouse Station, New Jersey, United States, 08889
United States, New York
GSK Investigational Site
Rochester, New York, United States, 14620
GSK Investigational Site
Stony Brook, New York, United States, 11794
United States, North Carolina
GSK Investigational Site
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
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44308-1062
GSK Investigational Site
Cleveland, Ohio, United States, 44109
GSK Investigational Site
University Heights, Ohio, United States, 44118
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213-2583
GSK Investigational Site
Sellersville, Pennsylvania, United States, 18960
United States, Tennessee
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
GSK Investigational Site
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
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
GSK Investigational Site
West Jordan, Utah, United States, 84084
United States, Virginia
GSK Investigational Site
Norfolk, Virginia, United States, 23510

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications:

Pichichero ME, Blatter MM, Kennedy WA, Hedrick J, Descamps D, Friedland LR. Acellular pertussis vaccine booster combined with diphtheria and tetanus toxoids for adolescents. Pediatrics. 2006 Apr;117(4):1084-93.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00109330 History of Changes
Other Study ID Numbers:	776423/001
Study First Received:	April 27, 2005
Last Updated:	July 24, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Prevention of Diphtheria, Tetanus, Pertussis

Additional relevant MeSH terms:

Diphtheria
Whooping Cough
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections

Infection
Respiratory Tract Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013