Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)

A Study to Assess the Anamnestic Immune Response 4 to 8 Years After a Primary Vaccination Series With HBVAXPRO

To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in this study will be either an investigational Merck product (Modified Process Hepatitis B Vaccine) or licensed ENGERIX-B vaccine.

Inclusion Criteria:

• Healthy Children 4 to 8 years of age
• Complete medical records documenting receiving a previous hepatitis B vaccination during the first year of life (for Cohort A and B only)
• Complete 3-dose vaccination with either a primary series of RECOMBIVAX HB or a primary series of ENGERIX-B (for Cohort A and B only)

Exclusion Criteria:

• Birth mother known to be a carrier of hepatitis B virus (Cohort C only)
• History of previous hepatitis B vaccine
• History of vaccination with any hepatitis B vaccine (Cohort C only)
• Known of suspected hypersensitivity to any component of RECOMBIVAX HB or ENGERIX-B (eg aluminum, yeast) recent administration of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product
• Receipt of investigational drugs or vaccines within 3 months prior to study vaccine or planned within study period
• Impairment of immunologic function or recent use of immunomodulatory medications
• A Combination of different hepatitis B vaccines used in the primary vaccination series (Cohort A and B only)