Immunogenicity and safety study of GSK Biologicals’ meningococcal vaccine GSK 134612 versus Menactra® in healthy adolescents/adults

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:

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.