Last updated: 11/07/2018 13:33:37
Immunogenicity, antibody persistence and safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) vaccines.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: Phase IIIb study to evaluate immunogenicity, antibody persistency and reactogenicity of DTPa - INFANRIX and dTpa - BOOSTRIX vaccines administered to healthy children previously primed with 3 doses of DTPa vaccine compared to placebo (HAVRIX®JUNIOR)
Trial description: To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK Biologicals’ DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for the two DTP vaccines and single blinded for the control arm.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: INFANRIX
Biological/vaccine: BOOSTRIX
Biological/vaccine: HAVRIX
Enrollment:
720
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Nolan T. et al. (2009) Booster vaccination of toddlers with reduced antigen content diphtheria-tetanus-acellular pertussis vaccine. Vaccine. 27(18):2410-2413.
Medical condition
acellular pertussis, Tetanus, Diphtheria
Product
SB263855
Collaborators
Not applicable
Study date(s)
May 2003 to January 2004
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 20 months
Accepts healthy volunteers
Yes
- Male or female children between and including 18 -20 months of age at the time of the vaccination.
- Completed a primary vaccination course with DTPa (INFANRIX) vaccine at 2, 4, and 6 months.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.
- Evidence of previous or intercurrent diphtheria, tetanus, or pertussis disease, or of vaccination against any of these diseases since completion of the primary course of DTPa (INFANRIX) vaccine.
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female children between and including 18 -20 months of age at the time of the vaccination.
- Completed a primary vaccination course with DTPa (INFANRIX) vaccine at 2, 4, and 6 months.
- Written informed consent obtained before study entry from the parents or guardians of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.
- Evidence of previous or intercurrent diphtheria, tetanus, or pertussis disease, or of vaccination against any of these diseases since completion of the primary course of DTPa (INFANRIX) vaccine.
Trial location(s)
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
Refer to study documents
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
Not applicable
Actual study completion date
2004-23-01
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
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