Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Nimenrix (Meningococcal vaccine 134612); Twinrix
Intervention description: Single dose intramuscular injection; 3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 611.0
Sex: All
Minimum age: 11 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: non-inferiority; adolescents; meningococcal vaccine

Summary:

      This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine
      134612 when given in an experimental co-administration versus vaccine 134612 alone and versus
      the experimental co-administration alone in healthy subjects aged 11 through 17 years. There
      will be 3 groups in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they and/or their parents/guardians can
             and will comply with the requirements of the protocol

          -  A male or female between, and including, 11 and 17 years of age at the time of the
             first dose of vaccine.

          -  Written informed consent obtained from the subject/ from the parent or guardian of the
             subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Previously completed routine childhood vaccinations to the best of his/her/the
             parents'/guardians' knowledge.

          -  If the subject is female and of childbearing potential, she must practice adequate
             contraception for 30 days prior to vaccination, have a negative pregnancy test and
             continue such precautions for two months after completion of the vaccination series.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the first 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 first vaccine dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within one month of the dose of vaccine.

          -  Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C,
             W-135 and/or Y within the last five years.

          -  Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup
             A, C, W-135 and/or Y.

          -  Previous vaccination with tetanus toxoid within the last month.

          -  Previous vaccination with hepatitis A and/or hepatitis B vaccine.

          -  Seropositivity for hepatitis A IgG, hepatitis B surface antigen, hepatitis B core
             antibody and/or hepatitis B surface antigen at screening.

          -  History of hepatitis A, hepatitis B and/or Neisseria meningitidis infection.

          -  Known exposure to hepatitis A and/or hepatitis B virus within three months preceding
             the first dose of study vaccine.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital
             or secondary), including human immunodeficiency virus (HIV) 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 reactions or allergic disease likely to be exacerbated by any component of
             either vaccine.

          -  Major congenital defects or serious chronic illness.

          -  Acute disease at the time of enrolment.

          -  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.