Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib
Condition: Whole Cell Pertussis; Haemophilus Influenzae Type b; Tetanus; Diphtheria; Hepatitis B
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis
Intervention: Zilbrix-Hib; Tritanrix™-HepB/ Hiberix™
Intervention description: Intramuscular injection, 1 dose; Intramuscular injection, 1 dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 8 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B; Tetanus; Diphtheria; Pertussis; Haemophilus influenzae type b Vaccines

Summary:

      The purpose of this observer-blind study is to generate immunogenicity data with one
      formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and
      to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK
      Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response.
      Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib
      vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act,
      Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who 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 8 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 a gestation period of 36 to 42 weeks inclusive.

          -  Administration of one dose of hepatitis B vaccine at birth

        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 with the exception of OPV.

          -  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
             during the period starting 30 days before the administration of the first vaccine
             dose, (with the exception of OPV).

          -  Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.

          -  Hepatitis B vaccine received after the first week of life.

          -  Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae or
             hepatitis B (except hepatitis B at birth).

          -  History of diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B
             diseases.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  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.

          -  Other conditions which in the opinion of the investigator may potentially interfere
             with interpretation of study outcomes.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.