The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal vaccine GSK134612
Intervention description: One dose, as intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 387.0
Sex: All
Minimum age: 2 Years
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Vaccines, conjugate; Immunogenicity; Meningococcal vaccine; Booster vaccination; Primary vaccination; Neisseria meningitides; Toddlers; Humans; Meningococcal disease

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 in a previous study (whose objectives & outcome measures are presented in a
      separate protocol posting with NCT number =00471081) will be evaluated. The safety and immune
      response of a booster dose of vaccine GSK134612 administered at 5 years post-primary
      vaccination will also be evaluated. In addition, the immune response to a dose of vaccine
      GSK134612 administered to age-matched controls not previously given a meningococcal vaccine
      will be evaluated.

      This protocol posting has been updated further to protocol amendment 2, dated 28 october
      2010. The sections impacted are summary, study design, outcome measures, intervention, and
      eligibility criteria.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy the following criteria for the persistence phase of the study
        entry:

          -  A male or female toddler who was vaccinated 1, 3 or 5 years ago with the last dose of
             MenACWY-TT in study with NCT number=00471081.

          -  Written informed consent obtained from parents/guardian of the subject.

          -  Healthy subjects as established by medical history before entering into the study.

          -  Having completed the active phase of the vaccination study with NCT number=00471081
             (i.e., not withdrawn, had received all planned doses of study vaccines, provided a
             post-vaccination blood sample after the final dose).

        All subjects must meet the following criteria prior to receiving the booster vaccination:

          -  Written informed consent obtained from parents/guardian of the subject.

          -  Subjects who can and will comply with the requirements of the protocol.

          -  Subjects who provide a blood sample 5 years after last vaccination in study with NCT
             number=00471081.

        All subjects must satisfy the following criteria prior to enrollment in the naïve control
        group:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol.

          -  A male or female between, and including, 5-6 years of age at the time of the
             vaccination.

          -  Written informed consent obtained from parents/guardian of the subject.

          -  Healthy subjects as established by medical history and history-directed physical
             examination before entering into the study.

        Exclusion Criteria:

        Exclusion criteria for persistence study entry

          -  Use of any investigational or non-registered product (drug or vaccine) within 30 days
             of each persistence timepoint.

          -  Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B,
             C, W-135, and/or Y outside of study with NCT number=00471081.

          -  History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.

          -  Any confirmed or suspected immunosuppressive or immunodeficiency condition based on
             medical history and physical examination (no laboratory testing is required).

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding each persistence timepoint.

          -  Concurrently participating in another clinical study within 30 days of each
             persistence timepoint, in which the subject has been or will be exposed to an
             investigational or a non-investigational product (pharmaceutical product or device).

          -  Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.

          -  Subjects withdrew consent to be contacted for follow-up studies.

        Exclusion criteria for primary (naive control)/booster vaccination at year 5 study entry
        (to be checked at Year 5)

          -  Child in care.

          -  Subjects who were enrolled in the Kaiser Healthcare system in study with NCT
             number=00471081, but are no longer enrolled.

          -  Use of any investigational or non-registered product (drug or vaccine) within 30 days
             preceding the primary (naive control)/booster vaccination, 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 primary (naive control)/booster
             vaccination. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5
             mg/kg/day. Inhaled and topical steroids are allowed).

          -  Vaccination with meningococcal polysaccharide or conjugate vaccine outside of study
             with NCT number=00471081.

          -  History of any meningococcal disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history (no laboratory testing is required).

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the primary (naive control)/booster vaccination or planned administration
             during the study period.

          -  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 (pharmaceutical product or device).

          -  Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.

          -  Subjects withdrew consent to be contacted for follow-up studies.

          -  Hypersensitivity to latex.

          -  Previous administration or planned administration/ administration of a vaccine not
             foreseen by the study protocol during the period starting from 30 days of the study
             vaccination (primary vaccination for the naïve control group and booster vaccination
             for subjects primed in Study with NCT number = 00471081) and ending 30 days after with
             the exception of any licensed inactivated influenza vaccine (live attenuated influenza
             vaccine is not allowed).

          -  Previous administration or planned administration of tetanus or any tetanus containing
             vaccine during the period starting from 30 days of the study vaccination and ending 30
             days after.

          -  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.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurological disorders or seizures.

          -  Acute disease at the time of vaccination. (Acute disease is defined as the presence of
             a moderate or severe illness with or without fever. All vaccines can be administered
             to persons with a minor illness such as diarrhea, mild upper respiratory infection
             with or without low-grade febrile illness, i.e., temperature by any method < 99.5°F
             (37.5°C).