Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal vaccine GSK 134612; MencevaxACWY TM
Intervention description: Intramuscular injection; Subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 400.0
Sex: All
Minimum age: 56 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Neisseria meningitidis; Meningococcal Vaccines; serogroups A,C, W-135 or Y; meningococcal diseases; meningococcal conjugate vaccine; Immunogenicity

Summary:

      This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK
      134612 given as single dose to healthy adults 56 years or older compared to the meningococcal
      polysaccharide vaccine MencevaxACWYTM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol

          -  A male or female 56 years of age or older at the time of the vaccination.

          -  Written informed consent obtained from the subject.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

          -  Non-child-bearing potential is defined as current tubal ligation, hysterectomy,
             ovariectomy or post-menopause.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Concurrent participation 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
             non-investigational product.

          -  Extended administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the vaccination. Inhaled and topical steroids are allowed.

          -  Any contra-indication to intramuscular and /or subcutaneous injection.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within 30 days prior to vaccination and ending 30 days after vaccination. (Vaccination
             with inactivated influenza vaccines, including H1N1, is allowed at any time during the
             study as per local recommendations).

          -  Previous vaccination with meningococcal serogroups A, C, W-135 and Y polysaccharide
             vaccine within 5 years prior to vaccination.

          -  Previous vaccination at any time with meningococcal serogroups A, C, W-135 and Y
             polysaccharide conjugate vaccine.

          -  Previous vaccination with tetanus toxoid containing vaccine within 5 years prior to
             vaccination.

          -  History of meningococcal disease due to serogroups A, C, W-135 or Y.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Family history of congenital or hereditary immunodeficiency.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine.

          -  History of neurological disorders and seizures

          -  History of Guillain-Barre syndrome.

          -  Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or pre-existing
             laboratory screening tests.

          -  Acute disease and/or fever at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first dose of study vaccine/product or planned administration during the
             study period.

          -  Pregnant or lactating female.

          -  Current chronic alcohol consumption and/or drug abuse.