study of evaluating safety and immunogenicity of 10µg/0.5ml hepatitis b vaccine

Conditions: Hepatitis B

Summary: 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.

Keywords: safety immunogenicity vaccine hepatitis b