Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)
Hepatitis B, Hepatocellular Carcinoma
About this trial
This is an interventional prevention trial for Hepatitis B
Eligibility Criteria
Inclusion Criteria: Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 10 days of age) Born to mothers with documented negative test for HBsAg within 9 months prior to delivery Exclusion Criteria: Infant born to mother with no prenatal care Known or suspected impairment of immunologic function Prior vaccination with any hepatitis B vaccine for infant or mother(within 6 months prior to the birth of infant.) Recent(<72 hours) history of febrile illness >/= 99.5 degrees F (>/= 37.5 degrees C) axillary or >/= 100.5 degrees F (>/= 38.1 degrees C) rectal Any prior administration of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product, or the receipt by the mother of either immunoglobulin or HBIG within 6 months prior to birth of the infant Receipt of investigational vaccines by mother or infant within 3 months prior to first injection with study vaccine or if scheduled to be given to the infant during the study Known or suspected hypersensitivity to any component of study vaccine (e.g., aluminum, yeast) Any infant who cannot be adequately followed for study visits during the course of the clinical study Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1
2
Modified Process Hepatitis B Vaccine
Recombivax HB™