Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Intervention: Havrix™; Infanrix™; ActHIB™
Intervention description: 2 intramuscular injections, 6 months apart; 1 intramuscular injection; 1 intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 468.0
Sex: All
Minimum age: 12 Months
Maximum age: 13 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis A

Summary:

      This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose
      inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis
      combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15
      months of age. The Protocol Posting has been updated in order to comply with the FDA
      Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects whose parents/guardians are believed by the investigator to be willing to
             comply with the requirements of the protocol

          -  A male or female child 12 or 13 months of age at the time of entry into the Enrolment
             Phase,

          -  Subjects must have previously received three doses each of DTaP and Hib vaccines
             during the first year of life. The three doses of DTaP vaccine must have been
             administered as either Infanrix™ or Pediarix™ and the three doses of Hib vaccine must
             have been administered as ActHIB™, HibTITER™, OmniHIB™.

          -  Subjects who, at 15 months of age, will have had at least six months elapse since
             their third dose of Infanrix™ or Pediarix™,

          -  Written informed consent obtained from the parents or guardian of the subject,

          -  Free of obvious health problems as established by medical history and history-directed
             physical examination before entering into the study, and

          -  Parents/guardian of the subject must have a telephone or be able to be contacted by
             telephone.

        Exclusion Criteria:

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccine(s) within 31 days preceding the first dose of study vaccine, or planned use
             during the study period,

          -  Chronic administration (defined as more than 14 days) of immuno-suppressant or other
             immune-modifying drugs within six months prior to vaccination or planned
             administration at any time during the study period.

          -  Planned administration or administration of any vaccine not foreseen by the study
             protocol during the period 42 days before and 31 days after each dose of study
             vaccine(s).

          -  Previous vaccination against DTaP using a commercially-available brand other than
             Infanrix™ or Pediarix™ or against Hib using a commercially-available brand other than
             ActHIB™, HibTITER™ or OmniHIB™.

          -  Previous vaccination with more than three doses of DTaP-containing vaccines or more
             than three doses of Hib-containing vaccines.

          -  Previous vaccination against hepatitis A,

          -  History or known exposure to hepatitis A,

          -  History of diphtheria, tetanus, pertussis and/or Haemophilus influenza type b,

          -  Known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenza type b
             within 31 days prior to the start of the study,

          -  History of non-response to any vaccine in the current routine immunization schedule,

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection,

          -  A family history of congenital, hereditary or infectious immunodeficiency or parental
             risk factors for HIV infection,

          -  History of allergic disease/reactions or hypersensitivity likely to be exacerbated by
             any component of Havrix™, Infanrix™ or ActHIB™ including 2-phenoxyethanol, neomycin
             and gelatin,

          -  History of hypersensitivity/allergic reaction to latex

          -  Major congenital defects or serious chronic illness,

          -  History of any neurologic disorder

          -  Acute disease at the time of vaccination.

          -  Administration of immunoglobulins and/or any blood products within three months prior
             to the first dose of study vaccine or planned administration at any time during the
             entire study period, i.e., the Enrolment Phase, the Active Phase and the Extended
             Safety Follow-up Phase