Last updated: 11/03/2018 00:15:08
Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results

Evaluate 4 different formulations of meningococcal serogroups A, C, W-135, Y conjugate vaccine when given as 1 dose to healthy subjects aged 15-19 yrs

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GSK study ID
103532
See study documents
Clinicaltrials.gov ID
NCT00196963
EudraCT ID
2004-004248-37
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Assess the immunogenicity, safety, reactogenicity of 1 dose of 4 different formulations of GSK Biologicals’ meningococcal conjugate vaccine (MenACWY) vs 1 dose of Mencevax™ ACWY in healthy subjects aged 15-19 yrs
Trial description: The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy subjects aged 15-19 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Meningococcal (vaccine)
    • Enrollment:
    125
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Meningococcal
    Product
    GSK134612A
    Collaborators
    Not applicable
    Study date(s)
    March 2005 to July 2005
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    15 - 19 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy male or female between, and including, 15 and 19 years of age at the time of vaccination.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Healthy male or female between, and including, 15 and 19 years of age at the time of vaccination.
    • Written informed consent obtained. Subject with previously completed routine childhood vaccinations to the best of his/her knowledge or his/her parents’/guardians’ knowledge.
    • Female subjects should be of non-childbearing potential, or abstinent, or using an adequate contraception. Exclusion criteria:
    • Previous vaccination against OR history of OR exposure within previous 12 months to meningococcal serogroup A, C, W-135 or Y disease.
    • Administration of a tetanus vaccine within 6 months before study vaccination.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
    • A family history of congenital or hereditary immunodeficiency.
    • History of any neurologic disorders or seizures.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Thuin, Belgium, 6530
    Status
    Study Complete
    Contact us

    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
    No longer a GSK study
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-01-07

    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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