Last updated: 11/07/2018 15:15:44

A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine

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GSK study ID
776423/001
See study documents
Clinicaltrials.gov ID
NCT00109330
EudraCT ID
Not applicable
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: A phase III, observer-blinded randomised, multi-centre clinical study of the safety, immunogenicity and consistency of three manufacturing lots of GSK Biologicals' candidate Tdap vaccine as compared to a US-licensed Td vaccine when given as a booster dose to healthy adolescents (10-18 years of age)
Trial description: This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of age).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Combined diphtheria, tetanus, acellular pertussis vaccine
    • Enrollment:
    4116
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Pichichero ME et al. (2006) Acellular pertussis vaccine booster combined with diphtheria and tetanus toxoids for adolescents. Pediatrics. 117 (4):1084-1093.
    Medical condition
    Diphtheria, Tetanus, acellular pertussis
    Product
    SB776423
    Collaborators
    Not applicable
    Study date(s)
    November 2002 to April 2004
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    10 - 18 years
    Accepts healthy volunteers
    Yes
    • Healthy adolescents with history of completed routine vaccination against diphtheria, tetanus, and pertussis (DTP).
    • Use of any other investigational drug or vaccine 30 days preceding study vaccination.
    • Chronic administration of immunosuppressants.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy adolescents with history of completed routine vaccination against diphtheria, tetanus, and pertussis (DTP).
    Exclusion criteria:
    • Use of any other investigational drug or vaccine 30 days preceding study vaccination.
    • Chronic administration of immunosuppressants.
    • Administration of pre-school DTP vaccine within previous 5 years.
    • Administration of Td booster within previous 10 years.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Mesa, Arizona, United States, 85201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02130
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Milford, Massachusetts, United States, 01757
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kingsport, Tennessee, United States, 37660
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Rochester, New York, United States, 14620
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02115
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 44 Results

    Study documents

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

    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
    2004-01-04

    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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