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