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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00263679

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 III

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Safety after vaccination.

Secondary Outcome Measures:

Immunogenicity and safety after vaccination

Estimated Enrollment:	334
Study Start Date:	November 2003

Detailed Description:

"• Subjects are randomized into two groups (1:1).

Treatment groups/Vaccination schedule:
- Tdap at Day 0 and Havrix at Day 30
- Havrix at Day 0, and Tdap at Day 30
Cohort: German children and adolescents who participated in GSK Biologicals' studies APV-118 and APV-120 previously vaccinated with a 5th consecutive dose of Pa-containing vaccine.
Thirty days after the first vaccination, subjects are crossed over to receive a second vaccination.
The duration of the study is approximately seven months per subject; an Active Phase of approximately two months and an Extended Safety Follow-Up Phase through six months after the last study vaccine dose."

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

Germany, Germany

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

clinical trials

GlaxoSmithKline

More Information

Study ID Numbers:	100406/004
Study First Received:	December 8, 2005
Last Updated:	December 8, 2005
ClinicalTrials.gov Identifier:	NCT00263679
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

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

Healthy
Diphtheria
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 16, 2009