Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine
Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine
The main objective of this study was to evaluate the safety and immunogenicity of 10µg/0.5ml
 and 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in
 saccharomyces cereviside yeast for infants and other age groups.
Inclusion Criteria (For Infant Group):

 -  Healthy full-term infant after birth, Apgar score ≥7.

 -  Guardian signed informed consent.

 -  Guardian can comply with the requirements of the clinical trial.

 -  Without administering immunoglobulin during the following period.

 -  Axillary temperature ≤37.0 ℃.

 Inclusion Criteria (For Other Age Groups):

 -  More than 1 month old healthy people, without the history of hepatitis B infection.

 -  Subjects or their guardians signed informed consent.

 -  After questioning medical history, physical examination and being judged as healthy
 subject.

 -  Without the history of hepatitis B vaccination.

 -  Subjects or their guardians can comply with requirements of the clinical trail.

 -  Without other prevention drugs or immunoglobulin administered within two weeks before
 the clinical trail or during the following period.

 -  Axillary temperature ≤37.0 ℃.

 Exclusion Criteria (For Infant Group):

 -  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.

 Exclusion Criteria (For Other Age Groups):

 -  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.