Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants
Condition: Haemophilus Influenzae Type b
Intervention: GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108); ActHIB™; Pentacel™; Pediarix™; Prevnar 13™; Rotarix™; Engerix™-B; Infanrix™
Intervention description: Three doses of 3 different manufacturing lots in primary study at 2, 4 and 6 months of age as intramuscular injection and one dose as booster vaccination.; Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination; Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination; Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection; Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection; Two oral doses in primary epoch at 2 and 4 months of age; Two or three doses in primary epoch at 2,( 4) and 6 months of age as intramuscular injection; One dose in the booster epoch at 15-18 months of age as intramuscular injection
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 4003.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: primary vaccination course; Haemophilus influenzae type b; infants, children; booster vaccination; immunogenicity; safety; Gram-negative bacterial infections; vaccines, conjugate

Summary:

      The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the
      vaccine, to address the relevant concomitant vaccine administrations and to provide a
      comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib
      vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6 and
      15-18 months of age. This study is designed with a primary and a booster phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects for whom the investigator believes that their parent(s)/Legally Acceptable
             Representative(s) (LAR[s]) can and will comply with the requirements of the protocol
             (e.g., completion of the diary card, return for follow-up visits).

          -  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 subject's parent/LAR.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Born after a gestation period of minimum 36 weeks.

          -  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
             enrollment.

        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 of a vaccine not foreseen by the study protocol within 30 days
             of the first dose of study vaccine and until 30 days after the booster dose.

          -  Previous vaccination against Haemophilus influenzae type b, diphtheria, tetanus,
             pertussis, Pneumococcus, rotavirus and/or poliovirus; more than one previous dose of
             hepatitis B vaccine.

          -  History of Haemophilus influenzae type b, diphtheria, tetanus, pertussis,
             pneumococcal, rotavirus, poliovirus, and hepatitis B diseases.

          -  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. All vaccines can be administered to persons with
             a minor illness.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          -  Concurrent participation in another clinical study, up to 30 days prior to study entry
             or 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).

          -  Child in care.

          -  History of intussusception.

          -  History of uncorrected congenital malformation of the gastrointestinal tract that
             would predispose the infant to intussusception.

          -  History of Severe Combined Immunodeficiency Disease.