Last updated: 11/29/2018 19:50:27
Open, five-year immunogenicity follow-up of subjects who previously received GSK Biologicals dTpa vaccine or GSKBiologicals pa vaccine and Lederles Td vaccine at 10 to 14 years of age in study 263855/004 (EXT: dTpa-004)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Open, five-year immunogenicity follow-up of subjects who previously received GSK Biologicals dTpa vaccine or GSKBiologicals pa vaccine and Lederles Td vaccine at 10 to 14 years of age in study 263855/004 (EXT: dTpa-004)
Trial description: Open, five-year immunogenicity follow-up of subjects who previously received GSK Biologicals dTpa vaccine or GSKBiologicals pa vaccine and Lederles Td vaccine at 10 to 14 years of age in study 263855/004 (EXT: dTpa-004)
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):1271-7.
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):179-85.
Mertsola J et al. Three-year immunogenicity of GSK Biologicals reduced antigen diphtheria-tetanus-acellular-pertussis (dTpa) vaccine in adolescents - 9th National Immunisation Conference PHAA, Cairns, Queensland, Australia, 19-20 August 2004.
Medical condition
Diphtheria, Tetanus, acellular pertussis
Product
Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine
Collaborators
Not applicable
Study date(s)
December 2000 to February 2001
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
2001-07-02
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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