Clinical Drug Experience Knowledgebase

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.