Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00346073

Purpose

GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. The current study will provide pivotal data in support of extending the age range for Boostrix vaccine to include adults 19-64 years of age.

Condition	Intervention	Phase
Diphtheria Tetanus Pertussis	Biological: Tetanus, reduced diph toxoids, acellular pertussis vaccine	Phase III

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough

Drug Information available for: Diphtheria-Pertussis-Tetanus Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Evaluate Immunogenicity and Safety of Boostrix Compared to Adacel When Administered as a Booster Vaccination in Adults Aged 19 to 64 Years of Age

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Antibody concentrations to all vaccine antigens.

Secondary Outcome Measures:

Solicited & unsolicited symptoms, SAEs

Estimated Enrollment:	2250
Study Start Date:	July 2006

Eligibility

Ages Eligible for Study:	19 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday) at the time of study vaccination.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding administration of study vaccine, or planned use during the active phase of the study.
Chronic administration of immunosuppressants or within six months prior to administration of study vaccine.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of study vaccine (with the exception of an influenza vaccine).
Administration of a diphtheria-tetanus (Td) booster within previous five years.
Administration of Tdap vaccine at any time prior to study entry. History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346073

Show 41 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	106316
Study First Received:	June 28, 2006
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00346073
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Immunogenicity, booster, dTpa
Prophylaxis for 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 14, 2009