Last updated: 11/03/2018 00:54:48
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 GSK’s Clinical Study Register is no longer maintained for this study.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

Request patient level data
GSK study ID
104702
See study documents
Clinicaltrials.gov ID
NCT00126945
EudraCT ID
2005-000965-21
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: A primary vaccination study to 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 years
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:
None (Open Label)
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:
    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)
    August 2005 to October 2005
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    15 - 19 years
    Accepts healthy volunteers
    Yes
    • Healthy male or female between, and including, 15 and 19 years of age at the time of vaccination.
    • Subject with previously completed routine childhood vaccinations to the best of his/her knowledge or his/her parents’/guardians’ knowledge.
    • 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.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy male or female between, and including, 15 and 19 years of age at the time of vaccination.
    • 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.
    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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Aarhus N, Denmark, 8200
    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
    2005-27-10

    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

    Participate in clinical trial
    Additional information
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website