Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns

Three types of subject: Neonates whose mothers are positive for both HBsAg and HBeAg Neonates whose mothers are positive for only HBsAg Neonates whose mothers are negative for both HBsAg and HBeAg INCLUSION CRITERIA:

• Full-term neonates with gestational age from 37 weeks to 42 weeks;

• Apgar scores are no less than 7 at birth;

• Neonates with standard body temperature (auxiliary temperature < 37.1°);

• Neonates weighing ≥ 2,500 grams at birth;

• Neonates with icteric index within the normal range (physiologic jaundice ispermitted);

• Informed consent form signed by parent/guardian;

• The requirements of the clinical trial protocol can be observed on the basis of theopinion of the investigator.

EXCLUSION CRITERIA:

• Subject's parent has a history of family diseases such as convulsion and braindiseases;

• Mothers have low immunologic function or a history of organ transplantation orhemodialysis;

• Subject's parent is allergic to any composition of Hepatitis B vaccine;

• A family history of thrombocytopenia, or other disturbance of blood coagulation, whichmay result in a contraindication for intramuscular injection;

• Known immunologic function damage;

• Mothers had received gamma globulin or immunoglobulin injection during pregnancy;

• Any congenital malformation

• Known or suspected to suffer from diseases such as active infection and cardiovasculardisease;

• Any condition believed by the investigator to have possible impact on trialevaluation.