Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age

An open, controlled comparison of Havrix administered alone or with Prevnar. The three groups
evaluated are: 1) Havrix alone, 2) Havrix plus Prevnar and 3) Prevnar followed by Havrix one
month later.

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.