A Study in Healthy Neonates of Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process
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