A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)
Hepatitis B Infection
About this trial
This is an interventional treatment trial for Hepatitis B Infection
Eligibility Criteria
Inclusion Criteria:
- In general good health
- Female participants have a negative pregnancy test just prior to vaccination on Day 1
Exclusion Criteria:
- History of Hepatitis B Infection or vaccination
- Known or suspected hypersensitivity to any component of Recombivax HB™ vaccine (e.g., aluminum, yeast)
- Administration of hepatitis B immune globulin, serum immune globulin, or any other blood-derived product within 3 months prior to vaccination on Day 1
- Receipt of an inactivated virus vaccine within 14 days or a live virus vaccine within 30 days prior to vaccination on Day 1
- Participation on prior study using an investigational drug or vaccine in prior 3 months
- Known or suspected impairment of immunologic function or recent use of immunomodulatory medications, excluding topical or inhaled steroids
- Pregnant or nursing women or women planning to become pregnant within the study period
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
V232 Modified Process Hepatitis B Vaccine: Lot A
V232 Modified Process Hepatitis B Vaccine: Lot B
V232 Modified Process Hepatitis B Vaccine: Lot C
V232 Current Process Hepatitis B Vaccine
Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot A administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot B administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot C administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) current process administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.