Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
Intervention: Menitorix™; Infanrix™ penta; Prevenar™; Infanrix™ IPV
Intervention description: Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.; Intramuscular injection, 3 doses in the primary study; Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.; Intramuscular injection, 1 dose in the Booster study.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 313.0
Sex: All
Minimum age: 8 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Conjugate vaccine; Persistence; Hib vaccine; Combination vaccine; Meningococcal vaccine; Safety; Preterm/full-term infants; Immunogenicity

Summary:

      The purpose of this Phase IIIb study is to evaluate the immunogenicity, reactogenicity &
      safety of GSK Biologicals' Hib-MenC vaccine (Menitorix™) when co-administered with GSK
      Biologicals' DTPa-HBV-IPV vaccine (Infanrix™ penta) & Wyeth's 7-valent pneumococcal conjugate
      vaccine (Prevenar™) in preterm infants as a 3-dose primary vaccination course during the
      first 6 months of life (at 2, 4, 6 months of age) and of a booster dose of Menitorix™ when
      co-administered with GSK Biologicals' DTPa-IPV vaccine (Infanrix IPV) and Wyeth's Prevenar in
      the second year of life (16-18 months of age). The control is a group of full-term infants
      receiving the same vaccines. The Protocol Posting has been updated in order to comply with
      the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy the following criteria at study entry:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  A male or female between, and including, 8 and 12 weeks of age at the time of the
             first vaccination.

          -  Written informed consent obtained from the parent or guardian of the subject.

        All preterm subjects must satisfy the following criteria at study entry:

          -  Born after a gestation period of less than or equal to 36 weeks (≤258 days).

          -  Medically stable, i.e. do not require significant medical support or ongoing
             management for debilitating disease and have demonstrated a clinical course of
             sustained recovery.

        All full-term subjects must satisfy the following criteria at study entry:

          -  Born after a gestation period between and including 37 and 42 weeks (≥259 days and
             ≤294 days).

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

        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 of immunosuppressants or other immune-modifying drugs since
             birth.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             in the period starting 30 days before the first dose of vaccine until the last study
             visit, except measles-mumps-rubella (MMR) and varicella vaccines which may be given
             according to local immunisation practices and except rotavirus oral vaccine which is
             allowed at anytime during the study after hospital discharge as per prescribing
             information.

          -  Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B,
             Haemophilus influenzae type b, meningococcal serogroup C and or Streptococcus
             pneumoniae disease, with the exception of hepatitis B vaccine or BCG vaccine given in
             the first month of life according to the national recommendations (although BCG and
             hepatitis B vaccines should have been given outside a 30-day window from the first
             administration of study vaccines).

          -  History of diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b,
             meningococcal disease and or S. pneumoniae disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection, based on medical history and physical
             examination.

          -  A family history of congenital or hereditary immunodeficiency.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine(s).

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at the time of enrolment.

          -  Administration of immunoglobulins (with the exception of monoclonal antibodies against
             respiratory syncytial virus [RSV]) and/or any blood products within one month (30
             days) preceding the first dose of study vaccines.

          -  Planned administration of immunoglobulins and/or any blood products during the active
             phase of the study.

        Specific criteria for the booster part of the study (to be checked at Visit 5, study month
        14):

          -  History of diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b,
             meningococcal disease and or S. pneumoniae disease.

          -  Previous vaccination, except the study vaccines and hepatitis birth dose, against
             diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b,
             meningococcal disease and or S. pneumoniae disease.

          -  Previous booster vaccination against diphtheria, tetanus, pertussis, polio, hepatitis
             B, H. influenzae type b, meningococcal disease and/or S. pneumoniae disease.