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

A Prospective, Randomized, Double-blind, Parallel-group, Controlled Study of the Immunogenicity and Safety of the Recombinant Hepatitis B Vaccine (Hepavax-Gene TF) and a Comparator Univalent Hepatitis B Vaccine in Neonates

The primary purpose of this study is to determine whether HepavaxGene TF is non-inferior to the comparator vaccine both at impeding hepatitis B transmission from mothers positive for chronic hepatitis B (Stratum 1) to their children and also in terms of seroconversion rate in children of mothers negative for chronic hepatitis B (Stratum 2) one month after completion of the immunization schedule.

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.