Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal vaccine GSK134612; Mencevax™ ACWY
Intervention description: One intramuscular dose; One subcutaneous dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1025.0
Sex: All
Minimum age: 11 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: immunogenicity; safety; meningococcal vaccine

Summary:

      The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority
      of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they and/or their parents/guardians can
             and will comply with the requirements of the protocol.

          -  A male or female between, and including, 11 and 17 years of age at the time of the
             vaccination.

          -  Written informed assent/consent obtained from the subject/ from the parent or guardian
             of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Previously completed routine childhood vaccinations to the best of the subject's/the
             subject's parent's/guardian's knowledge.

          -  If the subject is female, she must be of non-childbearing potential, or if she is of
             childbearing potential, she must practice adequate contraception for 30 days prior to
             vaccination, have a negative pregnancy test and continue such precautions for two
             months after vaccination.

        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 within the last five years.

          -  Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup
             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.

          -  A family history of congenital or hereditary immunodeficiency, until the immune
             competence of the potential vaccine recipient is demonstrated.

          -  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 dose of study vaccine or planned administration during the study period.

          -  Pregnant or lactating female.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.