Last updated: 11/07/2018 13:33:49
Open, phase IIIb, multicentric, safety and reactogenicity study of GlaxoSmithKline Biologicals’ reduced antigen content combined diphtheria-tetanusacellular pertussis vaccine (Boostrix™) administered as a booster dose to healthy children 4-6 years of age according to the international recommended prescribing information.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Open, phase IIIb, multicentric, safety and reactogenicity study of GlaxoSmithKline Biologicals’ reduced antigen content combined diphtheria-tetanusacellular pertussis vaccine (Boostrix™) administered as a booster dose to healthy children 4-6 years of age according to the international recommended prescribing information.
Trial description: Open, phase IIIb, multicentric, safety and reactogenicity study of GlaxoSmithKline Biologicals’ reduced antigen content combined diphtheria-tetanusacellular pertussis vaccine (Boostrix™) administered as a booster dose to healthy children 4-6 years of age according to the international recommended prescribing information.
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:
Bose et al. (2007) Safety and Reactogenicity of a low-dose Diphtheria-Tetanus-Acellular Pertussis Vaccine (Boostrix™) in Pre-School Indian Children. Indian Pediatrics. 44:421-424.
Bose et al. Safety and reactogenicity of a booster formulation diphtheria-tetanus-acellular pertussis vaccine in Indian children. Abstract presented at the 12th APCP, Colombo, Sri Lanka, 12-15 March 2007.
Dubey et al. Safety and reactogenicity of a booster formulation diphtheria-tetanus-acellular pertussis vaccine in Indian children. Abstract presented at the 43rd Annual Conference IAP, New Delhi, India, 5-8 January 2006.
Medical condition
Diphtheria-Tetanus-acellular Pertussis Vaccines
Product
SB263855
Collaborators
Not applicable
Study date(s)
May 2004 to November 2004
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
2004-23-11
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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Access to clinical trial data by researchers
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