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

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GSK study ID
213503/047
See study documents
Clinicaltrials.gov ID
NCT00263692
EudraCT ID
2011-003875-13
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2004-13-09
    Observational study model:
    Not applicable
    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
    Status
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    Location
    GSK Investigational Site
    Mechanicsville, Virginia, United States, 23111
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Whitehouse Station, New Jersey, United States, 08889
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Woodstock, Georgia, United States, 30188
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oakland, California, United States, 94612
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Torrance, California, United States, 90502
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jonesboro, Arkansas, United States, 72401
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
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    Scientific result summary
    Available language(s): English
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    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
    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.

    Additional information about the trial

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