Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
Condition: Infections, Meningococcal; Meningococcal Vaccines
MeSH terms: Meningococcal Infections
Intervention: Nimenrix; Mencevax
Intervention description: Single dose, intramuscular injection; Single dose, subcutaneous injection
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1504.0
Sex: All
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: safety; meningococcal vaccine; immunogenicity

Summary:

      The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority
      of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents or guardians can and will
             comply with the requirements of the protocol.

          -  A male or female between, and including, 2 and 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:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the first 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 first vaccine dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within one month of the dose of vaccine.

          -  Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C,
             W-135 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 serogroups
             A, C, W-135 and/or Y.

          -  Previous vaccination with tetanus toxoid within the last month.

          -  History of meningococcal disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital
             or secondary), including human immunodeficiency virus (HIV) infection, based on
             medical history and physical examination..

          -  History of reactions or allergic disease likely to be exacerbated by any component of
             the vaccine(s).

          -  Major congenital defects or serious chronic illness.

          -  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.