Clinical Trial of Recombinant Hepatitis B Vaccine (Hansenula Polymorpha, 10μg)

Inclusion Criteria: * Adults aged 18\~49 years, or children aged 1\~15 years, or neonates within 24 hours of birth; * Proven legal identity; * Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrollment ; Exclusion Criteria (For Adults): * Breast feeding, pregnant, or expected to conceive in the next 60 days; * History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc; * Congenital malformation, developmental disorders, genetic defects; * Autoimmune disease or immunodeficiency/immunosuppressive; * Severe chronic diseases, severe cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, liver Kidney disease, malignant tumor; * Severe nervous system disease or mental illness; * Asplenia or functional asplenia; * Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders; * Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry; * Long term history of alcoholism or drug abuse; * Administration of blood product within 3 months prior to the entry; * Administration of any other investigational drugs within 30 days prior to the entry; * Receipt of any attenuated live vaccine within 14 days prior to study entry; * Receipt of any subunit vaccine or inactivated vaccine within 7 days prior to study entry; * Any acute disease within 7 days prior to the study entry; * Axillaty temperature \> 37.0 °C; * Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators. Exclusion Criteria (For Children): * History of extra vaccination of Hepatitis B vaccine or vaccine containing hepatitis B except for the primary vaccination in the immunization planning program; * History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc; * Congenital malformation, developmental disorders, genetic defects; * Autoimmune disease or immunodeficiency/immunosuppressive; * Severe chronic diseases, severe cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, liver Kidney disease, malignant tumor; * Severe nervous system disease or mental illness; * Asplenia or functional asplenia; * Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders; * Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry; Long term history of alcoholism or drug abuse; * Administration of blood product within 3 months prior to the entry; * Administration of any other investigational drugs within 30 days prior to the entry; * Receipt of any attenuated live vaccine within 14 days prior to study entry; * Receipt of any subunit vaccine or inactivated vaccine within 7 days prior to study entry; * Any acute disease within 7 days prior to the study entry; * Axillaty temperature \> 37.0 °C; * Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators. Exclusion Criteria (For Neonates): * Neonates gestational age \<37 weeks or \>42 weeks; * Birth weight \<2500g for boy, \<2300g for girl; * Apgar score at birth \<8; * Positive for any of the mother's HBsAg, HBeAg, HBeAb, and HBcAb (check the laboratory report of the birth hospital); * Parents have family history of convulsions, epilepsy, encephalopathy, etc.; * Mother's immune function is low or history of organ transplantation or hemodialysis; * Mother has history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc; * Family history of coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders; * Immune system function damage, or parents have autoimmune diseases or immunodeficiency/immunosuppression; * Congenital malformation, developmental disorders, genetic defects; * Diognosed or suspected of active infection, cardiovascular disease, etc.; * Axillaty temperature \> 37.0 °C; * Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.