Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines
Condition: Neisseria Meningitidis; Haemophilus Influenzae Type b
Intervention: MenHibrix (Hib-MenCY-TT); Infanrix® Penta; Prevenar®; ActHIB®; Meningitec®; M-M-R®II; Varivax®; PedvaxHIB®
Intervention description: One intramuscular dose at 2, 4 and 6 months of age ( group A) and one intramuscular dose at 12 to 15 months of age (groups A and B); One intramuscular dose at 2, 4 and 6 months of age; One intramuscular dose at 2, 4 and 6 months of age; One intramuscular dose at 2, 4 and 6 months of age; One intramuscular dose at 2, 4 and 6 months of age; One subcutaneous dose at 12-15 months of age; One subcutaneous dose at 12 to 15 months of age; One intramuscular dose at 12 to 15 months of age
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1104.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Invasive Hib & N. meningitidis diseases

Summary:

      This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to
      control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4,
      6, and 12 to 15 months of age. Co-administration with live, attenuated measles, mumps, and
      rubella combination vaccine; and with live, attenuated varicella vaccine will be assessed
      with administration of the booster dose. The Protocol Posting has been updated in order to
      comply with the FDA Amendment Act, September 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects for whom the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol should be enrolled in the study.

          -  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.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Born after a gestation period between 36 and 42 weeks.

        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 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. Vaccination with hepatitis B at birth is
             accepted (although not mandatory). Influenza vaccination is allowed 30 days after
             administration of the third vaccine dose to 30 days preceding the booster dose.

          -  History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus,
             pertussis, hepatitis B, poliovirus, Streptococcus pneumoniae and/or varicella invasive
             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, tetanus toxoid, diphtheria toxoid,
             neomycin, polymyxin.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          -  Additional specific criteria for the booster part of the study

          -  History of or previous vaccination against measles, mumps, rubella or varicella.

          -  Previous booster vaccination with Hib or meningococcal serogroup C vaccine since the
             last visit of the primary phase.