Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates

Study Overview
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Brief Summary
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The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.

Official Title
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The Safety and Immunogenicity of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates

Conditions
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Hepatitis, Hepatitis B, Liver Diseases, Digestive System Diseases

Intervention / Treatment
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* Biological: 10μg/0.5ml recombinant hepatitis B vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are healthy full-term infants after birth, Apgar score ≥8; Subjects with a birth weight ≥ 2500g; Subjects' guardians are able to understand and sign informed consent; Subjects who can and will comply with the requirements of the protocol. Exclusion Criteria: Family history of eclampsia, epilepsy and encephalopathy; Subjects' birth mother had immune system dysfunction, or history of organ transplantation or blood dialysis; Subjects' parents had a medical history of allergic to any ingredient of the vaccine, including supplementary material and formaldehyde; Subjects' parents had a medical history of allergic to combined hepatitis A and B vaccine(HAB) or hepatitis B vaccine; Subjects had serious acute and chronic diseases; with temperature ≧37.1℃; Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.

Ages Eligible for Study
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Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10μg/0.5ml recombinant HBV vaccine<br>5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60. | Biological: 10μg/0.5ml recombinant hepatitis B vaccine<br>* 5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | Within 30 days after hepatitis B vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean titer of anti-hepatitis B virus surface antigen antibody | Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL. | The 30th day after whole course of hepatitis B vaccination | 
| Geometric mean titer of anti-hepatitis B virus surface antigen antibody | Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL. | The 1th year after whole course of hepatitis B vaccination | 
| Geometric mean titer of anti-hepatitis B virus surface antigen antibody | Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL. | The 2th year after whole course of hepatitis B vaccination | 
| Geometric mean titer of anti-hepatitis B virus surface antigen antibody | Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL. | The 3th year after whole course of hepatitis B vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recombinant hepatitis B vaccine, safety, immunogenicity