The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Adolescents/Adults
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Nimenrix; Blood sampling
Intervention description: One dose, as intramuscular injection; Blood samples will be collected from subjects 10-25 years of age as per enrollment in primary study and from subjects in the Nimerix Naive Group at Month 60 (Year 5) and 1 month post booster vaccination (Month 61).
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 818.0
Sex: All
Minimum age: 15 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal vaccine; Booster vaccination; Immunogenicity; Meningococcal disease; Safety

Summary:

      In this study, the concentration of antibody to the vaccine one year, three and five years
      after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine
      GSK134612 and Menactra® in a previous study (whose objectives & outcome measures are
      presented in a separate protocol posting with NCT number =00454909) will be evaluated. The
      safety and immune response to a booster dose of vaccine GSK134612 administered at 5 years
      post-primary vaccination and a primary vaccination of a newly enrolled group with GSK 134612
      vaccine will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

        Persistence phase:

          -  A male or female who was between and including 10 and 25 years of age at the time of
             primary vaccination in the study with NCT number = 00454909.

          -  Written informed consent obtained from parents/guardian of the subject and written
             informed assent obtained from the subject if the subject is less than 18 years of age,
             or written informed consent obtained from the subject if the subject has achieved the
             18th birthday.

          -  Healthy subjects as established by medical history.

          -  Having completed the active phase of the vaccination study with NCT number = 00454909.

        Booster phase:

          -  Written informed consent obtained from parents/guardian of the subject and written
             informed assent obtained from the subject if the subject is less than 18 years of age,
             or written informed consent obtained from the subject if the subject has achieved the
             18th birthday.

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol should be enrolled in the study.

          -  Healthy subjects as established by medical history and history-directed physical
             examination before entering into the study.

          -  If the subject is female, she must be of non-childbearing potential, i.e.,
             pre-menarche, have a current tubal ligation, hysterectomy, oophorectomy or be
             post-menopausal, or if she is of childbearing potential, she must practice adequate
             contraception for 30 days prior to vaccination, have a negative pregnancy test on the
             day of vaccination and continue adequate contraception for 2 months after vaccination.

        Additional inclusion criterion for the naïve control group:

        • A male or female between, and including, 15 and 30 years of age at the time of the
        vaccination.

        Exclusion Criteria:

        Persistence phase:

          -  Use of any investigational or non-registered product within 30 days of each
             persistence time point.

          -  Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C,
             W-135, and/or Y outside of study with NCT number = 00454909.

          -  History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding each persistence time point.

          -  Concurrently participating in another clinical study within 30 days of each
             persistence time point, in which the subject has been or will be exposed to an
             investigational or a non-investigational product.

          -  Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.

          -  Chronic alcohol or drug abuse.

          -  Subjects withdrew consent to be contacted for follow-up studies.

        Booster phase (to be checked at Year 5 for all subject, including naïve control group):

          -  Child in care

          -  Not enrolled in the Kaiser Healthcare system.

          -  Use of any investigational or non-registered product within 30 days preceding
             administration of the study vaccine, or planned use throughout the extended safety
             follow-up period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior administration of the booster dose.

          -  Previous vaccination with meningococcal polysaccharide or conjugate vaccine of
             serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909.

          -  History of any meningococcal disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition,including
             human immunodeficiency virus infection based on medical history and physical
             examination.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the booster vaccination or planned administration through Day 30 after
             vaccination.

          -  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.

          -  Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the period starting 30 days before until 30 days after the day of
             administration of the dose of vaccine(s) with the exception of any licensed
             inactivated influenza vaccine.

          -  Previous vaccination with tetanus and diphtheria toxoids within the last month.

          -  A family history of congenital or hereditary immunodeficiency, until the immune
             competence of the potential vaccine recipient is demonstrated.

          -  History of allergic disease or any reaction or hypersensitivity likely to be
             exacerbated by any component of the vaccine, including latex.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurological disorders or seizures.

          -  Previous history of Guillain-Barré syndrome

          -  Acute disease at the time of vaccination.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions within 2 months after vaccination.

          -  For groups A, B and C only: Subjects withdrew consent to be contacted for follow-up
             studies.

        Note: if the subject is female, prior to vaccination she must be of non-childbearing
        potential, or if she is of childbearing potential, she must practice adequate contraception
        for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination
        and continue adequate contraception for 2 months after vaccination.