Last updated: 11/20/2018 13:51:16
Comparative assessment of immunogenicity and reactogenicity of three different production lots of SB Biologicals combined diphtheria, tetanus, tricomponent acellular (PT 25 g + FHA 25 g + PRN 8 g) vaccine administered as a booster dose in healthy 15 to 24 month old children
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Comparative assessment of immunogenicity and reactogenicity of three different production lots of SB Biologicals combined diphtheria, tetanus, tricomponent acellular (PT 25 g + FHA 25 g + PRN 8 g) vaccine administered as a booster dose in healthy 15 to 24 month old children
Trial description: Comparative assessment of immunogenicity and reactogenicity of three different production lots of SB Biologicals combined diphtheria, tetanus, tricomponent acellular (PT 25 g + FHA 25 g + PRN 8 g) vaccine administered as a booster dose in healthy 15 to 24 month old children
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:
Schmitt HJ et al. (1997) Reactogenicity and immunogenicity of a booster dose of a combined diphtheria, tetanus, and tricomponent acellular pertussis vaccine at fourteen to twenty-eight months of age. J Pediatr. 130(4):616-623.
Medical condition
Diphtheria, Tetanus, acellular pertussis
Product
Diphtheria, Tetanus, Acellular Pertussis Vaccine Adsorbed
Collaborators
Not applicable
Study date(s)
March 1993 to April 1995
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
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
1995-30-04
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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