Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and
      the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving
      licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy
      infants at 2, 4, and 6 months of age. The study will also evaluate the safety and
      immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib
      conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15
      months of age.
    

Detailed description: 
      The subjects from this study will participate in one of three cohorts:

        -  US Safety and Immunogenicity (Cohort 1): All immunogenicity analyses in the primary and
           booster phases will be evaluated in this cohort. These subjects will also contribute to
           the safety analyses in the primary and booster phases.

        -  Safety Only (Cohort 2): Only safety objectives will be assessed in the primary and
           booster phases for this cohort.

        -  Non-US Safety and Immunogenicity (Cohort 3): Only descriptive immunogenicity results in
           the primary and booster phases will be reported for this cohort. These subjects will
           also contribute to the safety analyses in the primary and booster phases.

      Treatment allocation:

      Primary phase: Subjects will be randomized with balanced allocation (1:1:1:1) to 1 of the 4
      treatment groups and with a stratification according to the cohort. Assignment to a cohort
      will be based on study site.

      Booster phase: Subjects who received Hib-MenCY-TT vaccine in the primary phase will receive a
      booster dose of Hib-MenCY-TT vaccine. Subjects who received ActHIB in the primary phase will
      receive a booster dose of PedvaxHIB.

      During the 3-dose primary vaccination course, co-administration of Prevnar, Synagis, and/or
      rotavirus vaccine is permitted; co-administration of influenza vaccine is permitted at dose
      3.

      During the booster vaccination, co-administration of Prevnar, hepatitis A vaccine and
      influenza vaccine is permitted for all subjects in Cohort 1, 2 and 3; and co-administration
      of measles, mumps, rubella and varicella vaccine is permitted for all subjects in Cohort 2
      and 3.

      The study will be conducted in a double-blind fashion with regard to consistency of the 3
      manufacturing lots of Hib-MenCY-TT vaccine and single-blind fashion for Hib-MenCY-TT vaccine
      versus monovalent Hib vaccine. The parents/guardians will be blinded up to collection of all
      data pertaining to the period up to one month after booster vaccination. Therefore, the
      extended safety follow-up after the booster dose will be conducted in an unblinded manner.
      The person administering the vaccines will ensure that the parent/guardian does not see the
      vaccine vial used in reconstituting the vaccine. Due to the differences in the presentations
      of the candidate Hib-MenCY-TT vaccine and control vaccines, it is not possible to blind study
      personnel who administer the vaccines.
    

Intervention name(s): GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine; ActHIB; PedvaxHIB; Pediarix; Prevnar; M-M-R II; Varivax
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.; 3-dose intramuscular injection at 2, 4 and 6 months of age.; 1 booster dose by intramuscular injection at 12 to 15 months of age.; 3-dose intramuscular injection at 2, 4 and 6 months of age.; 3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.; 1 booster dose by subcutaneous injection at 12 to 15 months of age.; 1 booster dose by subcutaneous injection at 12 to 15 months of age
Other intervention name(s): Infanrix penta
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Primary and booster vaccination; Neisseria meningitidis; Hib disease; Meningococcal vaccine; Meningococcal disease; Children; Immunogenicity; Safety; Infants