Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults

• Immunogenicity in all subjects with respect to components of the vaccines [ Time Frame: Prior to (Month 0) and one month after vaccination (Month 1) ] [ Designated as safety issue: No ]
• Occurrence of solicited local and general symptoms [ Time Frame: Within 4 days (Day 0 to 3) following vaccination ] [ Designated as safety issue: No ]
• Occurrence of unsolicited non-serious adverse events [ Time Frame: Within 31 days (Day 0 to 30) following vaccination ] [ Designated as safety issue: No ]
• Occurrence of new onset of chronic illness(es) (NOCI) and serious adverse events (SAEs) [ Time Frame: From Month 0 through Month 6 ] [ Designated as safety issue: No ]

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.

• Biological: Meningococcal vaccine GSK 134612
  One intramuscular injection
• Biological: Menactra®
  One intramuscular injection

• Experimental: Group A
  Subjects were vaccinated with vaccine GSK134612 Lot A
  Intervention: Biological: Meningococcal vaccine GSK 134612
• Experimental: Group B
  Subjects were vaccinated with vaccine GSK134612 Lot B
  Intervention: Biological: Meningococcal vaccine GSK 134612
• Active Comparator: Group C
  Subjects were vaccinated with Menactra®
  Intervention: Biological: Menactra®

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.