Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
Intervention: Haemophilus influenzae type b and meningococcal serogroup C (vaccine); Priorix™; Hiberix™; Meningitec™
Intervention description: One intramuscular dose at 12-18 months of age; One subcutaneous dose at 12-18 months of age; One intramuscular dose at 12-18 months of age.; One intramuscular dose at 12-18 months of age
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 433.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal serogroup C diseases; H.influenzae type b diseases

Summary:

      The purpose of the primary phase of the study is to demonstrate the non-inferiority of a
      single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC)
      conjugate vaccine when given in the second year of life to subjects primed in infancy with a
      Hib vaccine, but not with a meningococcal serogroup C vaccine, versus commercially available
      Hib and MenC vaccines.

      In the extension phase, at Years 1, 2, 3, 4 & 5, one blood sample is taken at each year to
      follow the antibody persistence up to 5 years after vaccination. No additional vaccine is
      administered during the extension phase. The Protocol Posting has been updated in order to
      comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

        Primary phase:

          -  Subjects whom the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  A male or female between, and including, 12 and 18 months of age at the time of
             vaccination.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Previously completed routine childhood vaccinations to the best of his/her
             parents'/guardians knowledge.

          -  Having completed primary vaccination with two doses of Haemophilus influenzae type b
             outer membrane protein (Hib-OMP) containing vaccine OR three doses of diphtheria,
             tetanus, acellular pertussis and Haemophilus influenzae type b (DTPa/Hib) containing
             vaccine at least 6 months before the study start.

        Long-term persistence phase:

        - Having participated in the vaccination study 106445

        Exclusion Criteria:

        For the primary vaccination phase:

          -  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) or planned administration of
             immuno-suppressants or other immune-modifying drugs within six months prior to
             vaccination.

          -  Planned administration/administration of a vaccine not foreseen by the protocol during
             the period starting from 30 days before vaccination and ending 30 days after
             vaccination.

          -  Administration of a meningococcal vaccine not foreseen by the study protocol during
             the period starting at birth and ending at first dose.

          -  Previous administration of a booster dose of Hib vaccine.

          -  Previous vaccination against measles, mumps, rubella.

          -  History of H. influenzae type b, meningococcal serogroup C and/or confirmed measles,
             mumps or rubella diseases.

          -  Known exposure to measles, mumps or rubella within 30 days prior to the start of the
             study.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus infection.

          -  A family history of congenital or hereditary immunodeficiency.

          -  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 neurological disorders or more than one episode of febrile convulsion.

          -  Acute disease at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

        Additional exclusion criteria for the long-term persistence phase: to be checked each year.

          -  Previous administration of a booster dose of Hib, meningococcal serogroup C vaccines.

          -  History of H. influenzae type b, meningococcal serogroup C diseases.