A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)

A Study to Assess the Safety, Tolerability, and Immunogenicity of 2 Antigen Doses of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process Administered to Healthy Infants at 2, 4, and 6 Months of Age

This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine. This study was conducted to address the following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the modified process hepatitis B vaccine compared with a 10 microgram dose of the modified process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).

Inclusion Criteria:

• Participant is a healthy infant approximately 2 months of age

Exclusion Criteria:

• Birth mother is a known carrier of hepatitis B virus or another known carrier has lived in close contact with the participant
• Participant's birth mother did not receive any prenatal care
• Participant has previous history of hepatitis B infection
• Participant has been vaccinated against hepatitis B or birth mother was vaccinated within 6 months before birth of participant
• Participant has had a fever within 72 hours of study start
• Participant has received any blood-derived product or birth mother received blood-derived product within 6 months of birth of participant