Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal vaccine 134612; Menactra®
Intervention description: Single dose intramuscular injection.; Single dose intramuscular injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 873.0
Sex: All
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal Serogroups A, C, W-135 and/or Y Disease

Summary:

      The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK
      Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults
      11-25 years of age.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.

      The protocol posting has been updated following a protocol amendment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects whom the investigator believes can and will comply with the requirements of
             the protocol.

          -  A male or female between, and including, 10 and 25 years of age (has not attained
             his/her 26th birthday) at the time of the vaccination.

          -  Written informed consent obtained from parents/guardian of the subject and written
             informed assent obtained from the subject if the subject is less than 18 years of age,
             or written informed consent obtained from the subject if the subject has achieved the
             18th birthday.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  If the subject is female, she must be of non-childbearing potential, or if she is of
             childbearing potential, she must practice adequate contraception (including
             abstinence) for 30 days prior to vaccination, have a negative pregnancy test and
             continue such precautions for 2 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 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 or conjugate vaccine of
             serogroup A, C W-135, and/or Y.

          -  Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e.,
             Tdap, Td, and TT-containing vaccine within the last month).

          -  History of meningococcal disease due to serogroup A, C, W-135, or Y.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital
             or secondary), including human immunodeficiency virus (HIV) infection, based on
             medical history and physical examination (no laboratory testing is required).

          -  A family history of congenital or hereditary immunodeficiency, until the immune
             competence of the potential vaccine recipient is demonstrated.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Hypersensitivity to latex.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Previous history of Guillain-Barré Syndrome.

          -  Bleeding disorders, such as hemophilia or thrombocytopenia, or subjects on
             anti-coagulant therapy.

          -  Acute disease at the time of enrollment.

          -  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.

          -  Pregnant or lactating female.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.