Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age
Condition: Neisseria Meningitidis; Haemophilus Influenzae Type b
Intervention: Hib-MenCY-TT (MenHibrix®); Pediarix®; Rotarix®; Prevnar 13®; PedvaxHIB®; Havrix®
Intervention description: 4 doses administered intramuscularly (IM) in the right upper anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 in the HibCY Group.; 3 doses administered IM in the left upper anterolateral thigh at Day 0, Month 2 and Month 4. 2 doses administered IM in the left upper anterolateral thigh at Day 0 and Month 2 and 1 dose administered IM in the right upper anterolateral thigh at Month 4 in the PedHIB Group.; 2 doses administered orally at Day 0 and Month 2 each in the HibCY Group and PedHIB Group.; 4 doses administered IM in the left lower anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 each in the HibCY Group and PedHIB Group.; 3 doses administered IM in the right upper anterolateral thigh at Day 0, Month 2 and Month 10-13 in the PedHIB Group.; 2 doses administered IM in the left upper anterolateral thigh at Month 10-13 and Month 16-19 each in the HibCY Group and PedHIB Group.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 600.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Conjugate; Immunogenicity; Hib-MenCY-TT vaccine; Haemophilus type b; Safety; Reactogenicity

Summary:

      The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK
      Biologicals' Hib-MenCY-TT (MenHibrix®) vaccine co-administered with Rotarix, Prevnar 13 and
      Havrix as compared to PedvaxHIB co-administered with Rotarix, Prevnar 13 and Havrix in
      infants and toddlers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion
             of the investigator, can and will comply, with the requirements of the protocol.

          -  A 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(s)/LAR(s) of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Born full-term (i.e. born after a gestation period of at least 37 weeks inclusive).

          -  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.

        Exclusion Criteria:

          -  Child in care.

          -  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 of immunosuppressants or other immune-modifying drugs since
             birth prior to the first vaccine dose. Inhaled and topical steroids are allowed.

          -  Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b,
             diphtheria, tetanus, pertussis, rotavirus, pneumococcus, hepatitis A and/or
             poliovirus; more than one previous dose of hepatitis B vaccine.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             in the period starting 30 days before and ending 30 days after the dose of vaccines.
             Subjects may receive inactivated influenza vaccine or pandemic influenza vaccines any
             time during the study according to the national recommendation. Measles, mumps,
             rubella and varicella vaccination are allowed 30 days before or 30 days after the
             final vaccination of Hib-MenCY-TT or PedvaxHIB.

          -  History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus,
             pertussis, pneumococcus, hepatitis B, hepatitis A, rotavirus, and/or poliovirus
             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 vaccines, including dry natural latex rubber. Hypersensitivity to any component of
             the vaccines, including gelatin or neomycin.

          -  Major congenital defects or serious chronic illnesses.

          -  History of any neurologic disorders or seizures. A single, simple febrile seizure is
             allowed.

          -  Subjects with history of intussusceptions or uncorrected congenital malformation of
             the gastrointestinal tract that would predispose for intussusceptions.

          -  Acute disease and/or fever at the time of enrollment.

          -  Administration of immunoglobulins and/or blood products since birth or planned
             administration during the study period.