Last updated: 11/19/2018 11:11:00
Double-blind randomised comparative assessment of the immunogenicity and reactogenicity of 3 different lots of SB Bios´ combined diphtheria, tetanus, acellular pertussis vaccine.The vaccine will be admin to healthy infants as a primary vaccination course of 3 consecutive doses at 3-4-5 months of age
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Double-blind randomised comparative assessment of the immunogenicity and reactogenicity of 3 different lots of SB Bios´ combined diphtheria, tetanus, acellular pertussis vaccine.The vaccine will be admin to healthy infants as a primary vaccination course of 3 consecutive doses at 3-4-5 months of age
Trial description: Double-blind randomised comparative assessment of the immunogenicity and reactogenicity of 3 different lots of SB Bios´ combined diphtheria, tetanus, acellular pertussis vaccine.The vaccine will be admin to healthy infants as a primary vaccination course of 3 consecutive doses at 3-4-5 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:
Schmitt H-J et al. Clinical experience of a tricomponent acellular pertussis combined with diphtheria and tetanus toxoids for primary vaccination in 22505 infants. J Pediatr; 1996; 129 (5): 695-701.
Medical condition
Diphtheria;Tetanus;acellular pertussis
Product
Diphtheria, Tetanus, Acellular Pertussis Vaccine Adsorbed
Collaborators
Not applicable
Study date(s)
September 1991 to December 1994
Type
Interventional
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
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1994-31-12
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
Additional information
Not applicable
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