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

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00109330

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 Tetanus Pertussis	Biological: Combined diphtheria, tetanus, acellular pertussis vaccine	Phase III

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough

Drug Information available for: Diphtheria-Tetanus Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by GlaxoSmithKline:

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

Show 42 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	776423/001
Study First Received:	April 27, 2005
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00109330
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Prevention of Diphtheria, Tetanus, Pertussis

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Cough
Whooping Cough

Diphtheria
Clostridium Infections
Tetanus
Whooping cough
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Bordetella Infections
Corynebacterium Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 15, 2009