Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate 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.