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.

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

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.

Study Overview

• Status: Completed
• Conditions: Tetanus; Diphtheria; Acellular Pertussis
• Intervention / Treatment: Biological: Prophylaxis: Diphtheria, tetanus and pertussis

• Study Type: Interventional
• Enrollment (Actual): 321
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety after vaccination.

Secondary Outcome Measures

Outcome Measure
Immunogenicity and safety after vaccination

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Mertsola J et al. The safety of repeated administration of Boostrix™, a reduced-antigen-content dTpa booster. Abstract presented at Excellence In Paediatrics (EIP). Florence, Italy, 3-6 December 2009.
• Mertsola J et al. The immunogenicity and safety of repeated administration of dTpa booster in adolescents and young adults. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
• Mertsola J et al. The safety of repeated administration of reduced-antigen-content dTpa boosters. Abstract presented at WSPID- 6th World Congress. Buenos Aires, Argentina, 19-22 November 2009
• 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. doi: 10.1016/j.jpeds.2006.06.016.
• 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. doi: 10.1016/j.vaccine.2007.05.012. Epub 2007 Jun 4.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): May 1, 2004
• Study Completion (Actual): October 1, 2004

Study Registration Dates

• First Submitted: December 8, 2005
• First Submitted That Met QC Criteria: December 8, 2005
• First Posted (Estimate): December 9, 2005

Study Record Updates

• Last Update Posted (Estimate): September 15, 2016
• Last Update Submitted That Met QC Criteria: September 14, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Corynebacterium Infections; Whooping Cough; Diphtheria
• Other Study ID Numbers: 100406/004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Clinical Study Report
   Information identifier: 100406/004
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Statistical Analysis Plan
   Information identifier: 100406/004
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 100406/004
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Study Protocol
   Information identifier: 100406/004
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Informed Consent Form
   Information identifier: 100406/004
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Dataset Specification
   Information identifier: 100406/004
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No