Status:
COMPLETED
The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Conditions:
Virus Disease
DNA Virus Infections
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE3
Brief Summary
The primary safety objective of this study is to assess the safety of 10 mcg recombinant hepatitis B vaccine in the Chinese health neonates. The primary immunogenicity objective is to assess the antib...
Detailed Description
During the early 1980s, human plasma-derived hepatitis B vaccines were developed in China. The production of these vaccines has not been adequate to meet China's need. Since the introduction of recomb...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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
- 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
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- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
1740 Patients enrolled
Trial Details
Trial ID
NCT01183611
Start Date
April 1 2007
End Date
September 1 2010
Last Update
September 17 2010
Active Locations (1)
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1
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China, 210009