Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates

The Safety and Immunogenicity of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates

The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.

Inclusion Criteria:

• Subjects who are healthy full-term infants after birth, Apgar score ≥8;
• Subjects with a birth weight ≥ 2500g;
• Subjects' guardians are able to understand and sign informed consent;
• Subjects who can and will comply with the requirements of the protocol.

Exclusion Criteria:

• Family history of eclampsia, epilepsy and encephalopathy;
• Subjects' birth mother had immune system dysfunction, or history of organ transplantation or blood dialysis;
• Subjects' parents had a medical history of allergic to any ingredient of the vaccine, including supplementary material and formaldehyde;
• Subjects' parents had a medical history of allergic to combined hepatitis A and B vaccine(HAB) or hepatitis B vaccine;
• Subjects had serious acute and chronic diseases;
• with temperature ≧37.1℃;
• Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.