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 is permitted);
• Informed consent form signed by parent/guardian;
• The requirements of the clinical trial protocol can be observed on the basis of the opinion of the investigator.

Exclusion criteria

• Subject's parent has a history of family diseases such as convulsion and brain diseases;
• Mothers have low immunologic function or a history of organ transplantation or hemodialysis;
• Subject's parent is allergic to any composition of Hepatitis B vaccine;
• A family history of thrombocytopenia, or other disturbance of blood coagulation, which may 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 cardiovascular disease;
• Any condition believed by the investigator to have possible impact on trial evaluation.