Clinical trial NCT00263679: 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acellular Pertussis
Diphtheria
Tetanus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-09
Enrollment: 321
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Safety after vaccination.
Secondary outcomes:
measure: Immunogenicity and safety after vaccination
Other outcomes:
Locations:
city: Kehl
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Oberkirch
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Limburg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Erkrath
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Krefeld
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Willich
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Husum
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.