Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
MeSH terms: Influenza, Human
Intervention: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014; ActHIB; Pediarix/Infanrix Penta
Intervention description: 3-dose intramuscular injection; 3-dose intramuscular injection; 3-dose intramuscular injection
Intervention MeSH terms: PENTA
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 4432.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prophylaxis; Neisseria meningitidis Vaccines, conjugate; Infants; Meningococcal vaccines; H. influenzae type B vaccine; Humans; Safety

Summary:

      The primary phase of this study is evaluating the safety 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.

      This protocol posting deals with objectives & outcome measures of the primary phase of the
      study. The objectives & outcome measures of the Booster phase are presented in a separate
      protocol posting (NCT number = 00345683).

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
    

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
             enrolment.

          -  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).

          -  Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b,
             diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of
             hepatitis B vaccine.

          -  In country(ies) where Prevnar will be provided by GSK Biologicals, previous
             vaccination with Prevnar.

          -  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.

          -  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).