Last updated: 11/04/2018 01:03:09
Comparison of GSK Biologicals' DTaP-IPV candidate vaccine to DTaP and IPV separately administered vaccines in terms of immune response and safety
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Open, randomized, phase II, clinical trial to compare the immunogenicity and safety of a booster dose of GSK Biologicals' DTaP-IPV vaccine (Infanrix®-IPV) co-administered with a booster dose of Merck and Company's M-M-R®II, to that of separate injections of GSK Biologicals' DTaP vaccine (Infanrix®), Aventis Pasteur's IPV (IPOL®) and M-M-R®II administered as booster doses to healthy children 4 to 6 years of age.
Trial description: The aims of this study are to compare the immunogenicity and safety of the GSK Biologicals' combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years when co-administered with MMR vaccine in subjects who had previously received four doses of Infanrix, three doses of poliovirus-containing vaccine and MMR vaccination.
Primary purpose:
Prevention
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3
Enrollment:
401
Observational study model:
Not applicable
Primary completion date:
2004-13-09
Time perspective:
Not applicable
Clinical publications:
Black S et al. (2006) Immunogenicity and safety of a combined DTaP-IPV vaccine compared with separate DTaP and IPV vaccines when administered as pre-school booster doses with a second dose of MMR vaccine to healthy children aged 4-6 years. Vaccine. 24(35-36):6163-6171.
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, acellular pertussis, Tetanus
Product
SB213503
Collaborators
Not applicable
Study date(s)
November 2002 to September 2004
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
4 - 6 years
Accepts healthy volunteers
Yes
- Healthy children between and including 4 and 6 years of age.
- Previously received 4 doses of GSK Biologicals' DTaP, 3 doses of IPV vaccine and 1 dose of measles, mumps, and rubella vaccine.
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
- Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy children between and including 4 and 6 years of age. -Previously received 4 doses of GSK Biologicals' DTaP, 3 doses of IPV vaccine and 1 dose of measles, mumps, and rubella vaccine.
Exclusion criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period. -Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period -Administration of immunoglobulins and/or blood products within 3 months prior to vaccination.
Trial location(s)
Location
GSK Investigational Site
Mechanicsville, Virginia, United States, 23111
Status
Study Complete
Location
GSK Investigational Site
Whitehouse Station, New Jersey, United States, 08889
Status
Study Complete
Location
GSK Investigational Site
Woodstock, Georgia, United States, 30188
Status
Study Complete
Location
GSK Investigational Site
Oakland, California, United States, 94612
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90502
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70128
Status
Study Complete
Location
GSK Investigational Site
Stony Brook, New York, United States, 11794
Status
Study Complete
Location
GSK Investigational Site
Berlin, New Jersey, United States, 08009
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Endwell, New York, United States, 13760
Status
Study Complete
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Ruston, Louisiana, United States, 71270
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60614
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30062
Status
Study Complete
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
Completed
Actual primary completion date
2004-13-09
Actual study completion date
2004-28-09
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.
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