Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
Intervention: GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine; ActHIB; Pediarix; Prevnar; Menomune
Intervention description: Primary phase: 3 IM doses Booster phase: 1 IM dose; Primary phase: 3 IM doses Booster phase: 1 IM dose; Primary phase: 3 IM doses; Primary phase: 3 IM doses Booster phase: 1 IM dose; Primary phase: 1 SC dose
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 756.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 15 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; Primary & booster vaccination; Infants; Meningococcal vaccine; Safety; Children; Hib disease; Meningococcal disease

Summary:

      This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT
      vaccine compared to a control group receiving licensed Hib conjugate vaccine, each
      administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups
      A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age.

      The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a
      booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age.
      The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to
      receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For Groups A and B

               -  Subjects for whom the investigator believes that parents/guardians can and will
                  comply with the requirements of the protocol.

               -  Healthy male or female between, and including, 6 and 12 weeks of age at the time
                  of the first 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 the study.

               -  Born after a gestation period between 36 and 42 weeks.

               -  Infants who have not received a previous dose of hepatitis B vaccine or those who
                  have received only 1 dose of hepatitis B vaccine administered at least 30 days
                  prior to enrollment.

          -  For Group C

               -  Subjects for whom the investigator believes that parents/guardians can and will
                  comply with the requirements of the protocol.

               -  Healthy male or female between, and including, 3 and 5 years of age at the time
                  of the first 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 the study.

        Exclusion Criteria:

        -For Groups A and B

          -  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 30 days of the first dose of study vaccine(s).

          -  Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b,
             diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than
             one previous dose of hepatitis B vaccine.

          -  History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus,
             pertussis, hepatitis B, poliovirus, and/or Streptococcus pneumoniae disease.

          -  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 vaccine(s), including 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.

        For Group C

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the 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 vaccine dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within 30 days of the dose of study vaccine.

          -  Previous vaccination against Neisseria meningitidis.

          -  History of Neisseria meningitidis disease.

          -  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 vaccine, including dry natural latex rubber

          -  Major congenital defects or serious chronic illness.

          -  Acute disease at time of enrollment.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding vaccination or planned administration during the study period.