Last updated: 11/06/2018 23:35:23
An open, multicentric, phase IV clinical trial to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ combined diphtheria-tetanus-acellular pertussis vaccine (INFANRIX™) administered to healthy infants at 2, 4 and 6 months of age.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open, multicentric, phase IV clinical trial to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ combined diphtheria-tetanus-acellular pertussis vaccine (INFANRIX™) administered to healthy infants at 2, 4 and 6 months of age.
Trial description: An open, multicentric, phase IV clinical trial to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ combined diphtheria-tetanus-acellular pertussis vaccine (INFANRIX™) administered to healthy infants at 2, 4 and 6 months of age.
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:
Jin Han Kang et al. (2007) The immunogenicity and safety of a three-component DTaP vaccine in Korean infants. Korean Journal of Pediatrics Infectious Disease. 50 (4):355-362.
Medical condition
Diphtheria-Tetanus-acellular Pertussis Vaccines
Product
SB208355
Collaborators
Not applicable
Study date(s)
June 2004 to March 2005
Type
Not applicable
Phase
4
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
2005-16-03
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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