Assessment of GSK Biologicals' Tdap Candidate Vaccine Administered as a Booster (6th Dose) in Terms of Immunogenicity and Safety to Children and Adolescents Previously Vaccinated With Five Doses of an Acellular Pertussis-containing Vaccine. - Full Text View

Purpose

The aims of this study are to evaluate the safety and immunogenicity of a booster dose of GSK Biological's candidate Tdap vaccine containing 0.3 mg Al when administered to healthy school children and adolescents (9-13 years of age) previously vaccinated with five consecutive doses of Pa-containing vaccine. The inclusion of hepatitis A vaccine (Havrix®) as a control vaccine enables this study to be conducted in a double-blinded in terms of immunogenicity and safety assessments.

Condition	Intervention	Phase
Prophylaxis: Diphtheria, Tetanus and Pertussis	Biological: Prophylaxis: Diphtheria, tetanus and pertussis	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Phase III, Double-blinded, Randomized, Multicenter, Clinical Study to Assess the Safety and Immunogenicity of GSK Biologicals' Tdap 0.3 mg Candidate Vaccine When Given as a Booster Dose to Healthy School Children and Adolescents (9-13 Years of Age), Previously Vaccinated With a 5th Consecutive Dose of Acellular Pertussis-containing Vaccine, in Studies APV-118 or APV-120

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Safety after vaccination.

Secondary Outcome Measures:

Immunogenicity and safety after vaccination

Enrollment:	321
Study Start Date:	November 2003
Study Completion Date:	May 2004
Primary Completion Date:	May 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	9 Years to 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

- Subjects previously enrolled and vaccinated in GSK Biologicals' studies APV-118 and APV-120 and who were 9 through 13 years of age

Exclusion Criteria:

Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period
Administration of immunoglobulins and/or blood products within 3 months prior to vaccination

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263679

Locations

Germany
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
GSK Investigational Site
Oberkirch, Baden-Wuerttemberg, Germany, 77704
GSK Investigational Site
Limburg, Hessen, Germany, 65549
GSK Investigational Site
Erkrath, Nordrhein-Westfalen, Germany, 40699
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47798
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24939
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24943
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24944
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications:

Zepp F, Habermehl P, Knuf M, Mannhardt-Laakman W, Howe B, Friedland LR. Immunogenicity of reduced antigen content tetanus-diphtheria-acellular pertussis vaccine in adolescents as a sixth consecutive dose of acellular pertussis-containing vaccine. Vaccine. 2007 Jul 20;25(29):5248-52. Epub 2007 Jun 4.

Zepp F, Knuf M, Habermehl P, Mannhardt-Laakmann W, Howe B, Friedland LR. Safety of reduced-antigen-content tetanus-diphtheria-acellular pertussis vaccine in adolescents as a sixth consecutive dose of acellular pertussis-containing vaccine. J Pediatr. 2006 Nov;149(5):603-610.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00263679 History of Changes
Other Study ID Numbers:	100406/004
Study First Received:	December 8, 2005
Last Updated:	March 1, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diphtheria
Whooping Cough
Tetanus
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

ClinicalTrials.gov processed this record on May 16, 2013