Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal vaccine GSK 134612; Menactra®
Intervention description: One intramuscular injection; One intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1013.0
Sex: All
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Neisseria meningitidis; Adult; Adolescent; Safety; Vaccines, conjugate; Meningococcal vaccines; Immunogenicity

Summary:

      The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK
      Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through
      25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK
      134612 vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy ALL of the following criteria at study entry:

          -  Subjects whom the investigator believes that they and/or their parent(s)/Legally
             Acceptable Representative(s) can and will comply with the requirements of the
             protocol.

          -  A male or female between, and including, 10 and 25 years of age at the time of the
             vaccination.

          -  Written informed consent obtained from the subject/from the parent or Legally
             Acceptable Representative(s) of the subject. Assent will be obtained from subjects who
             are still legally minors in line with local rules and regulations.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Previously completed routine childhood vaccinations to the best of subject's/Legally
             Acceptable Representative(s)'s knowledge.

          -  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 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 (defined as more than 14 days) 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.

          -  Previous vaccination with meningococcal polysaccharide or conjugate vaccine.

          -  Previous vaccination with vaccine components within the last month.

          -  History of meningococcal disease.

          -  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 is demonstrated.

          -  History of allergic reactions or disease likely to be exacerbated by any component of
             either vaccine, or by dry natural rubber latex.

          -  History of any neurologic disorders, including Guillain-Barré Syndrome.

          -  Major congenital defects or serious chronic illness.

          -  Acute disease at the time of enrollment.

          -  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.

          -  Child in care.

          -  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.