Last updated: 11/07/2018 15:12:31
Open, 1-year, phase III, immunogenicity follow-up of subjects who previously received GSK Biologicals’ dTpa-IPV vaccine or GSK Biologicals’ dTpa (BoostrixTM) and Pasteur Mérieux’s IPV vaccine (IPV Mérieux) administered separately, at 4 to 8 years of age in study 711866/001 (dTpa-IPV-001)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Open, 1-year, phase III, immunogenicity follow-up of subjects who previously received GSK Biologicals’ dTpa-IPV vaccine or GSK Biologicals’ dTpa (BoostrixTM) and Pasteur Mérieux’s IPV vaccine (IPV Mérieux) administered separately, at 4 to 8 years of age in study 711866/001 (dTpa-IPV-001)
Trial description: Open, 1-year, phase III, immunogenicity follow-up of subjects who previously received GSK Biologicals’ dTpa-IPV vaccine or GSK Biologicals’ dTpa (BoostrixTM) and Pasteur Mérieux’s IPV vaccine (IPV Mérieux) administered separately, at 4 to 8 years of age in study 711866/001 (dTpa-IPV-001)
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:
Saenger et al. (2007) Booster vaccination and 1 year follow-up of 4-8 year old children with a reduced-antigen-content dTpa-IPV vaccine. Eur J Pediatr. .166(12):1229-1236.
Medical condition
Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines
Product
SB711866
Collaborators
Not applicable
Study date(s)
January 2003 to May 2003
Type
Not applicable
Phase
2/3
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
2003-05-05
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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