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.
Minimum age: N/A.
Maximum age: 75 Years.
Gender(s): Both.
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.