Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine

Exclusion Criteria

• •Apgar score of infant after birth \<7.
• •With nervous system damage after birth, or with the family history of mental illness, epilepsy or encephalopathy.
• •With immune system dysfunction.
• •With vitamin deficiency.
• •With acute febrile diseases, or infectious diseases.
• •With congenital malformations, developmental disorders or serious chronic illness.
• •With thrombocytopenia or other coagulation disorders.
• •Administered immunoglobulin during the period of the clinical trail, especially administered Hepatitis B immunoglobulin to the infant of Hepatitis B infected mother.
• •With endemic disease.
• •Participate another clinical trial during the period of the clinical trail.
• •Any circumstance that may affect clinical trail evaluation.
• •With allergies, seizures, epilepsy, encephalopathy or with family history of mental illness.
• •Allergic to any component of the study vaccine.
• •With immune system dysfunction.
• •Hepatitis B infected people.
• •Anti-HBs was positive screened by ELISA kit.
• •Either anti-HBs ≥10mIU/ml or HBsAg was positive screened by Radioimmunoassay method.
• •With acute febrile diseases or infectious diseases.
• •With congenital malformations, developmental disorders or serious chronic illness.
• •With thrombocytopenia or other coagulation disorders.
• •With the history of severe allergic reactions.
• •Administered other prevention drugs or immunoglobulin within two weeks before the clinical trail or during the following period.
• •With any acute illness that requires antibiotics or anti-viral treatment within 7 days before the clinical trail.
• •With vitamin deficiency.
• •With the history of febrile convulsion.
• •Axillary temperature ≥38.0 ℃ within 3 days before the clinical trail.
• •Participate another clinical trial during the period of the clinical trail.
• •Pregnant woman.
• •Any circumstance that may affect clinical trail evaluation.