Last updated: 11/06/2018 23:21:27
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.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
321
Primary completion date:
2004-05-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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 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 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 et al. (2006) Safety of reduced antigen content tetanus-diphtheria-acellular pertussis (Tdap) vaccine in adolescents as a 6th consecutive dose of acellular-pertussis containing vaccine. J Pediatr. 149 (5): 603-610.
Zepp et al. (2007) Immunogenicity of reduced antigen content tetanus-diphtheria-acellular pertussis vaccine in adolescents as a sixth consecutive dose of acellular pertussis-containing vaccine. Vaccine. 25 (29): 5248-5252.
Medical condition
acellular pertussis, Diphtheria, Tetanus
Product
SB776423
Collaborators
Not applicable
Study date(s)
November 2003 to October 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
9 - 13 years
Accepts healthy volunteers
Yes
- Subjects previously enrolled and vaccinated in GSK Biologicals’ studies APV-118 and APV-120 and who were 9 through 13 years of age
- 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
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24943
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24939
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Study Complete
Location
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24944
Status
Study Complete
Location
GSK Investigational Site
Erkrath, Nordrhein-Westfalen, Germany, 40699
Status
Study Complete
Showing 1 - 6 of 13 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2004-05-05
Actual study completion date
2004-29-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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