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
Intervention: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine; ActHIB; PedvaxHIB; Pediarix; Prevnar; M-M-R II; Varivax
Intervention description: 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
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 4441.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 15 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Primary and booster vaccination; Neisseria meningitidis; Hib disease; Meningococcal vaccine; Meningococcal disease; Children; Immunogenicity; Safety; Infants

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.
    

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 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.

          -  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.

          -  Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.

        Exclusion Criteria:

          -  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). (Synagis® [palivizumab,
             MedImmune], Prevnar (Prevenar), rotavirus vaccine, and influenza vaccine are allowed.

          -  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, Haemophilus influenzae type b, diphtheria, tetanus,
             pertussis, hepatitis B, and/or poliovirus disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination (no laboratory testing is required).

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines, 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.

          -  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).

        Additional specific criteria for the US subjects in Cohort 1. In addition, for Cohorts 2
        and 3, subjects should not be administered M-M-R II and Varivax if any of these criteria
        apply:

          -  History of measles, mumps, rubella or varicella.

          -  Previous vaccination against measles, mumps, rubella or varicella.

          -  Hypersensitivity to any component of the vaccines, including gelatin or neomycin.

          -  Patients receiving immunosuppressive therapy.

          -  Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant
             neoplasms affecting the bone marrow or lymphatic systems.

          -  Individuals with primary and acquired immunodeficiency states.

          -  Individuals with a family history of congenital or hereditary immunodeficiency, until
             the immune competence of the potential vaccine recipient is demonstrated.

          -  Individuals with active tuberculosis.

          -  Acute disease at time of booster vaccination.