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.

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00263679
First received: December 8, 2005
Last updated: March 1, 2012
Last verified: February 2012
  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:


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:
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 April 17, 2014