Last updated: 11/29/2018 19:40:20
Randomised clinical study of the consistency of three lots of SB Biologicals dTpa vaccine in terms of immunogenicity and reactogenicity, and of the immunogenicity and reactogenicity of SB Biologicals pa vaccine and Lederle’s Td vaccine when administered as a booster dose to healthy adolescents (10-14 years old)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Randomised clinical study of the consistency of three lots of SB Biologicals dTpa vaccine in terms of immunogenicity and reactogenicity, and of the immunogenicity and reactogenicity of SB Biologicals pa vaccine and Lederle’s Td vaccine when administered as a booster dose to healthy adolescents (10-14 years old)
Trial description: Randomised clinical study of the consistency of three lots of SB Biologicals dTpa vaccine in terms of immunogenicity and reactogenicity, and of the immunogenicity and reactogenicity of SB Biologicals pa vaccine and Lederle’s Td vaccine when administered as a booster dose to healthy adolescents (10-14 years old)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Edelman K et al. (2007) Immunity to pertussis 5 years after booster immunization during adolescence. Clin Infect Dis. 44(10):1271-1277.
Edelman KJ et al. (2004) Pertussis-specific cell-mediated and humoral immunity in adolescents 3 years after booster immunization with acellular pertussis vaccine. Clin Infect Dis.39(2):179-185.
Minh NNT et al. (1999) Acellular vaccines containing reduced quantities of pertussis antigens as a booster in adolescents. Pediatrics. 104(6):e70.
Pasquale D et al. (2005) Management of pertussis in adolescents and adults: the role of a reduced-antigen combined diphtheria-tetanus-acellular pertussis (dTpa) vaccine. J Prev Med Hyg. 46(1):33-41.
Medical condition
Diphtheria, Tetanus, acellular pertussis
Product
Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine
Collaborators
Not applicable
Study date(s)
September 1997 to December 1997
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
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
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1997-22-12
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
Not applicable
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