The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates

Inclusion Criteria: 1. A group (A1-A2)Subjects born to a mother positive for both HBsAg and hepatitis B e antigen. • Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 1 day of age) • Subjects with a 5-minute Apgar score ≥ 7. • Subjects with temperature \<37.1°C on axillary setting • Subjects with a birth weight ≥ 2.5 kg. • Normal neonatal jaundice. * Written informed consent obtained from the parent(s) of the subject. * Subjects who the investigator believes that their parent(s) can and will comply with the requirements of the protocol. 2. B group(B1-B2) Subjects born to a mother positive for HBsAg, but negative for the hepatitis B e antigen. • Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 1 day of age) • Subjects with a 5-minute Apgar score ≥ 7. • Subjects with temperature \<37.1°C on axillary setting • Subjects with a birth weight ≥2.5 kg. • Normal neonatal jaundice. • Written informed consent obtained from the parent(s) of the subject. • Subjects who the investigator believes that their parent(s) can and will comply with the requirements of the protocol 3. C group（C1-C3）Subjects born to a mother negative for HBsAg, hepatitis Be Antigen, antibody to hepatitis B core antigen, antibody to hepatitis B e-antigen. * Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 1 day of age) * Subjects with a 5-minute Apgar score ≥ 7. * Subjects with temperature \<37.1°C on axillary setting * Subjects with a birth weight ≥ 2.5 kg. * Normal neonatal jaundice. * Written informed consent obtained from the parent(s) of the subject. * Subjects who the investigator believes that their parent(s) can and will comply with the requirements of the protocol. Exclusion Criteria: 1. A group (A1-A2) Subjects born to a mother positive for both HBsAg and e Antigen. Exclusion criteria for the first shot • Subjects born to a mother positive for antibody to HBsAg. • Family history of seizures or progressive neurological disease. • Family history of congenital or hereditary immunodeficiency. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. • Subjects born to a mother had administrated of immunoglobulins and/or any blood products during the pregnancy. • Use of any investigational or non-registered product other than the study vaccines since birth, or planned use during the study period. • Born to a mother known or suspected to be positive for HIV. * Family history of congenital or hereditary immunodeficiency. * Children in care. * Neonatal jaundice requiring systemic treatment. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Major congenital defects or serious chronic illness, including perinatal brain damage. * Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives Exclusion criteria for the second and third shots * Dysgenopathy * Any reaction or hypersensitivity to the hepatitis B vaccines. * Acute infections * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives <!-- --> 1. B group (B1-B2) Subjects born to a mother positive for HBsAg, but negative for the hepatitis B e antigen. Exclusion criteria for the first shot • Subjects born to a mother positive for antibody to HBsAg or e antigen. • Family history of seizures or progressive neurological disease. • Family history of congenital or hereditary immunodeficiency. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. • Subjects born to a mother had administrated of immunoglobulins and/or any blood products during the pregnancy. • Use of any investigational or non-registered product other than the study vaccines since birth, or planned use during the study period. • Born to a mother known or suspected to be positive for HIV. • Family history of congenital or hereditary immunodeficiency. • Children in care. • Neonatal jaundice requiring systemic treatment. • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. • Major congenital defects or serious chronic illness, including perinatal brain damage. • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives Exclusion criteria for the second and third shots • Dysgenopathy • Any reaction or hypersensitivity to the hepatitis B vaccines. • Acute infections * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. 3 C group (C1-C3) Subjects born to a mother negative for HBsAg, hepatitis Be Antigen, antibody to hepatitis B core antigen, antibody to hepatitis B e-antigen. Exclusion criteria for the first shot • Subjects born to a mother positive for antibody to HBsAg, or e antigen, or antibody to B core antigen or antibody to hepatitis B e-antigen. • Family history of seizures or progressive neurological disease. • Family history of congenital or hereditary immunodeficiency. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. • Subjects born to a mother had administrated of immunoglobulins and/or any blood products during the pregnancy. • Use of any investigational or non-registered product other than the study vaccines since birth, or planned use during the study period. • Born to a mother known or suspected to be positive for HIV. • Family history of congenital or hereditary immunodeficiency. • Children in care. * Neonatal jaundice requiring systemic treatment. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Major congenital defects or serious chronic illness, including perinatal brain damage. * Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives Exclusion criteria for the second and third shots * Dysgenopathy * Any reaction or hypersensitivity to the hepatitis B vaccines. * Acute infections * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives