Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)

A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process

The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™).

Inclusion Criteria:

• Healthy male and female older adults greater than or equal to 50 years of age

Exclusion Criteria:

• Any adult with a history of previous hepatitis B infection
• A history of vaccination with any hepatitis B vaccine
• Recent (<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF)
• Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast)
• Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product
• Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine
• Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine
• Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine
• Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids
• Pregnant women, nursing mothers, and women planning to become pregnant within the study period
• Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives