Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Mencevax ACWY; GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]
Intervention description: One dose, Subcutaneous injection; One dose, Intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1170.0
Sex: All
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adolescent; Vaccine, conjugate; Adult; Neisseria meningitidis; Immunogenicity; Meningococcal vaccine; Safety

Summary:

      The purpose of the observer-blinded study is to determine the immunogenicity and safety of
      one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK 134612 compared to
      one dose of Mencevax™ ACWY in healthy subjects 18-25 years of age. In addition, this study
      will compare the immunogenicity of two lots of GSK's 134612 vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy all of the following criteria at study entry:

          -  Subjects whom the investigator believes they can and will comply with the requirements
             of the protocol will be enrolled in the study.

          -  A male or female between, and including, 18 and 25 years of age the time of the
             vaccination.

          -  Written informed consent obtained from the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject:

               -  has practiced adequate contraception for 30 days prior to vaccination, and

               -  has a negative pregnancy test on the day of vaccination, and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for 2 months after vaccination.

        Exclusion Criteria:

        The following criteria should be checked at the time of study entry. If any exclusion
        criterion applies, the subject must not be included in the study:

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             within 30 days preceding the dose of study vaccine, or planned use during the study
             period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to vaccination. (For corticosteroids, this will mean prednisone <10
             mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed).

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within one month of the dose of vaccine, with the exception of any licensed
             inactivated influenza vaccine, including H1N1 vaccine.

          -  Previous vaccination with meningococcal polysaccharide vaccine within the last five
             years.

          -  Previous vaccination with meningococcal conjugate vaccine.

          -  Previous vaccination with tetanus-toxoid or tetanus-toxoid containing vaccine within
             the last month.

          -  History of meningococcal disease.

          -  Seropositive for HIV or HBsAg (for subjects in the Philippines only).

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus 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 has been demonstrated.

          -  History of reactions or allergic disease likely to be exacerbated by any component of
             either vaccine.

          -  History of any neurologic disorders, including Guillain-Barré Syndrome.

          -  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.

          -  Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product.