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.


Eligibility Criteria:
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.