Last updated: 11/20/2018 16:20:18
Open, randomised phase IIIb, clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ DTaP-IPV vaccine, with GSK Biologicals’ DTaP and Aventis Pasteur MSD’s IPV vaccines administered to healthy children, previously vaccinated with 4 doses of DTaP and polio vaccines, and co-administered with GSK Biologicals’ MMR vaccine
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Open, randomised phase IIIb, clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ DTaP-IPV vaccine, with GSK Biologicals’ DTaP and Aventis Pasteur MSD’s IPV vaccines administered to healthy children, previously vaccinated with 4 doses of DTaP and polio vaccines, and co-administered with GSK Biologicals’ MMR vaccine
Trial description: Open, randomised phase IIIb, clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ DTaP-IPV vaccine, with GSK Biologicals’ DTaP and Aventis Pasteur MSD’s IPV vaccines administered to healthy children, previously vaccinated with 4 doses of DTaP and polio vaccines, and co-administered with GSK Biologicals’ MMR vaccine
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:
Jacquet JM et al. (2006) Safety and immunogenicity of a combined DTPa-IPV vaccine administered as a booster from 4 years of age: a review. Vaccine. 24(13):2440-2448.
Jaquet JM et al. A comparison of booster vaccination with either DTPa-IPV combined or DTPa plus IPV in separate injections, when co-administered with MMR. Abstract presented at the 23rd Annual Meeting ESPID, Valencia, Spain, 18-20 May 2005.
Marshall H et al. (2006) A comparison of booster immunisation with a combination DTPa-IPV vaccine or DTPa plus IPV in separate injections when co-administered with MMR, at age 4-6 years. Vaccine. 24 (35-36):6120-6128.
Weston WM et al. (2008) Kinrix: A new combination DTaP-IPV vaccine for children aged 4-6 years. Expert Rev Vaccines. 7( 9):1309-1320.
Medical condition
Diphtheria, Tetanus, acellular pertussis
Product
Diphtheria, Tetanus, Acellular Pertussis Vaccine Adsorbed
Collaborators
Not applicable
Study date(s)
April 2002 to January 2003
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
2003-15-01
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
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
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