Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children

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

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 and 13 months of age at the time of entry into the
Enrollment Phase

- 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 42 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. (For
corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled,
nasal and topical steroids are allowed.) Planned administration or administration of
any vaccine not foreseen by the study protocol during the period 31 days before and 31
days after each dose of study vaccine(s).

- Previous vaccination against hepatitis A,

- History of hepatitis A,

- Known exposure to hepatitis A,

- Previous vaccination against measles, mumps, rubella and/or varicella,

- History of measles, mumps, rubella and/or varicella,

- Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the
start of the study,

- Planned chronic use of salicylates during the 6-week period following administration
of the doses of study vaccine(s),

- 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 HavrixTM, M-M-RII or VARIVAXTM, including 2-phenoxyethanol, neomycin
and gelatin,

- History of anaphylactic or anaphylactoid reactions to egg proteins,

- History of hypersensitivity/allergic reaction to latex. Note: The tip cap and the
rubber plunger of the HavrixTM needleless pre-filled syringes contain dry natural
latex rubber.

- Major congenital defects or serious chronic illness,

- Active untreated tuberculosis,

- History of significant blood dyscrasias

- History of any neurologic disorder (a history of febrile seizures not associated with
an underlying neurological disorder does not exclude the subject)

- 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