Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix); Mencevax™ ACWY; Meningitec™
Intervention description: One intramuscular dose.; One subcutaneous dose.; One intramuscular dose.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 613.0
Sex: All
Minimum age: 1 Year
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal serogroups A, C, W-135 and/or Y diseases; Conjugate vaccine; Immunogenicity; Meningococcal vaccine; Persistence; Non-inferiority

Summary:

      This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the
      vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in
      children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2
      years) as controls. In the long-term follow-up phase of the study, the long-term protection
      offered by the vaccines will be assessed up to 5 years after vaccination.

      Subjects will be randomized in the primary vaccination phase of the study; no new subjects
      will be enrolled during the long-term follow-up phase of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parent or guardian can and will
             comply with the requirements of the protocol.

          -  A male or female between, and including, 1 through 10 years of age at the time of
             vaccination.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Previously completed routine childhood vaccinations to the best of his/her
             parents/guardians' knowledge.

        Exclusion Criteria:

        For the primary phase:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use
             during the study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the vaccine dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within one month of the dose of vaccine(s).

          -  Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W,
             and/or Y (for subjects below 6 years) or within the last five previous years (for
             subjects 6 years old or above).

          -  Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup
             A, C, W, and/or Y.

          -  Previous vaccination with tetanus toxoid containing vaccine within the last 28 days.

          -  History of meningococcal disease due to serogroup A, C, W, or Y.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection.

          -  A family history of congenital or hereditary immunodeficiency.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the first dose of study vaccine or planned administration during the study
             period.

        For the long term persistence phase:

          -  History of meningococcal serogroup A, C, W, and/or Y disease.

          -  Administration of a meningococcal polysaccharide or a meningococcal polysaccharide
             conjugate vaccine not planned in the protocol.