Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix); GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix); Infanrix®; ActHIB®; Pediarix®
Intervention description: One dose in the booster phase as intramuscular injection; Three doses in the priming phase and, for Menhibrix 2 Group, one dose in the booster phase as intramuscular injection; One dose as intramuscular injection; Three doses in the priming phase as intramuscular injection; Three doses in the priming phase as intramuscular injection
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 1558.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal disease; Toddlers; Neisseria meningitidis; Meningococcal vaccines; Immunogenicity; Human serum bactericidal assay; Safety; Vaccines, conjugate; Booster vaccination

Summary:

      The purpose of the study is to characterize the immunogenicity & safety of a booster dose of
      GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months
      of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's
      Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and
      open-label for the booster phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects for whom the investigator believes that parents/guardians can and will comply
             with the requirements of the protocol.

          -  A male or female between, and including, 6 and 12 weeks of age (+ 6 days) at the time
             of the first vaccination.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Born after 36 weeks gestation.

          -  For inclusion in the booster phase, subjects must have received all three doses in the
             primary phase.

        Exclusion Criteria:

        Exclusion criteria for enrolment (primary 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) of immunosuppressants or other
             immune-modifying drugs since birth.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within 30 days of the first dose of study vaccine(s).

          -  Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b,
             diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of
             hepatitis B vaccine.

          -  History of Neisseria meningitidis, hepatitis B, Haemophilus influenzae type b,
             diphtheria, tetanus, polio or pertussis diseases.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines, or by dry natural latex rubber.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at time of enrollment.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          -  Concurrent participation 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).

        Exclusion criteria for enrolment (booster phase)

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding entry into the booster phase (Visit 4), or
             planned use during the study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs since birth.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within 30 days of entry into the booster phase (Visit 4) with the exception of
             Prevnar® and Hib (see the following three criteria) (Note; licensed influenza vaccine
             is allowed throughout the study)

          -  Planned administration/administration of a fourth dose of Prevnar® within 30 days of a
             booster dose of Infanrix®

          -  Previous administration of a booster dose of Hib prior to entry to the booster phase.

          -  Previous administration of a primary dose of Hib vaccine that is not part of the study
             protocol.

          -  Previous vaccination against Neisseria meningitidis that is not part of the study
             protocol.

          -  Previous vaccination with diphtheria, tetanus and pertussis antigens outside of the
             primary phase of the study.

          -  History of Neisseria meningitidis, Hib, diphtheria, tetanus or pertussis diseases.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines, or by dry natural latex rubber.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at time of enrollment.

          -  Administration of immunoglobulins and/or any blood products within the past 3 months
             or planned administration during the study period.

          -  Concurrent participation 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).