Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Intervention: GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix); Prevnar™
Intervention description: Two doses, administered intramuscularly in the right anterolateral thigh.; One dose, administered intramuscularly in the left anterolateral thigh.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 521.0
Sex: All
Minimum age: 12 Months
Maximum age: 13 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose
      inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in
      children as young as 15 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female child 12 or 13 months of age at the time of entry into the Enrollment
             Phase,

          -  Free of obvious health problems,

          -  Subjects must have previously received three doses of Prevnar in his/her first year of
             life.

        Exclusion Criteria:

          -  Use of any investigational or non-registered drug or vaccine within 42 days preceding
             the first dose of study vaccine, or planned use during the study period,

          -  Chronic administration of immuno-suppressant or other immune-modifying drugs within
             six months prior to vaccination or planned administration at any time during the study
             period. (For corticosteroids, this will mean prednisone, or equivalent, less than 0.5
             mg/kg/day. Inhaled, nasal and topical steroids are allowed.),

          -  Administration of the ACIP-recommended fourth dose of Prevnar prior to entering the
             Enrollment Phase of the study,

          -  Planned administration or administration of any vaccine not foreseen by the study
             protocol within the period of 42 days before and 30 days after each dose of study
             vaccine(s),

          -  Previous vaccination against hepatitis A,

          -  History of hepatitis A or known exposure to hepatitis A,

          -  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 (e.g., neomycin, 2-phenoxyethanol) or Prevnar (e.g.,
             diphtheria toxoid),

          -  Major congenital defects or serious chronic illness,

          -  History of any neurologic disorder (history of febrile seizures not associated with an
             underlying neurological disorder does not exclude the subject),

          -  Acute disease, defined as the presence of a moderate or severe illness with or without
             fever, 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.