Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.

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.