Last updated: 11/03/2018 20:31:57
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 GSK’s Clinical Study Register is no longer maintained for this study.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

Study to evaluate meningococcal serogroups A,C,W-135,Y conjugate vaccine when given as 1 dose to healthy subjects aged 18-25 years

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GSK study ID
134612/003
See study documents
Clinicaltrials.gov ID
NCT00196950
EudraCT ID
Not applicable
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 safety, reactogenicity, immunogenicity & long-term persistence of one intramuscular dose of GSK Biologicals' MenACWY conjugate vaccine vs one subcutaneous dose of Mencevax™ ACWY in healthy adults aged 18-25 yrs
Trial description: The purpose of this study is to evaluate the safety, reactogenicity, immunogenicity and persistence up to three years after administration of one dose of the MenACWY conjugate vaccine when given to young adults aged 18-25 years.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Meningococcal (vaccine)
    • Enrollment:
    50
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Østergaard L et al. (2009) Immunogenicity, reactogenicity and persistence of meningococcal A, C, W-135 and Y-tetanus toxoid candidate conjugate (MenACWY-TT) vaccine formulations in adolescents aged 15–25 years. Vaccine. 27(1):161-168
    Medical condition
    Infections, Meningococcal
    Product
    GSK134612A
    Collaborators
    Not applicable
    Study date(s)
    September 2003 to October 2003
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 25 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy male or female between, and including, 18 and 25 years of age at the time of vaccination.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Healthy male or female between, and including, 18 and 25 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.
    • 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.
    • History of chronic alcohol consumption and/or drug abuse

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Gosselies, Belgium, 6041
    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
    2003-25-10

    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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