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
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    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
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    Location
    GSK Investigational Site
    Milford, Massachusetts, United States, 01757
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kingsport, Tennessee, United States, 37660
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rochester, New York, United States, 14620
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02115
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Jordan, Utah, United States, 84084
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Norwich, Connecticut, United States, 06360
    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
    Norfolk, Virginia, United States, 23510
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fullerton, California, United States, 92835
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84109
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Escondido, California, United States, 92021
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Durham, North Carolina, United States, 27710
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Golden, Colorado, United States, 80401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Redondo Beach, California, United States, 90277
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15213-2583
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Centennial, Colorado, United States, 80112
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Akron, Ohio, United States, 44308-1062
    Status
    Study Complete
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    Location
    GSK Investigational Site
    University Heights, Ohio, United States, 44118
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Yorba Linda, California, United States, 92886
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77030
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bardstown, Kentucky, United States, 40004
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Stony Brook, New York, United States, 11794
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44109
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sellersville, Pennsylvania, United States, 18960
    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
    Jonesboro, Arkansas, United States, 72401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boulder, Colorado, United States, 80304
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bryan, Texas, United States, 77802
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New Bedford, Maine, United States, 2740
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15241
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Woburn, Massachusetts, United States, 01801
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Middletown, Connecticut, United States, 06457
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68178
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Georgetown, Texas, United States, 78626
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Temple, Texas, United States, 76508
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lumberton, North Carolina, United States, 28358
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rolling Hills Est, California, United States, 90274
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chapel Hill, North Carolina, United States, 27514
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tempe, Arizona, United States, 85282
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32209
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60614
    Status
    Study Complete
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    Study documents

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