Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3, Randomized, Controlled, and Blinded Clinical Trial to Evaluate Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine for Infants and Other Age Groups.

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: 3 dose of 10µg/0.5ml hepatitis B vaccine
* Biological: 3 dose of 5µg/0.5ml hepatitis B vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 75 Years

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10µg/0.5ml hepatitis B vaccine<br>3 dose of 10µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside.Produced by Beijing Tiantan Biological Products Co., Ltd. Lot number: YHB2008063S1. | Biological: 3 dose of 10µg/0.5ml hepatitis B vaccine<br>* 3 dose of 10µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside were administered intramuscular injection at 0, 1, 6 momth interval.<br>|
| Active Comparator: 5µg/0.5ml hepatitis B vaccine<br>3 dose of 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside.Produced by Beijing Tiantan Biological Products Co., Ltd. Lot number:20080603. | Biological: 3 dose of 5µg/0.5ml hepatitis B vaccine<br>* 3 dose of 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside were administered intramuscular injection at 0, 1, 6 momth interval.<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 | To analyze the number of subjects with adverse events within 28 days after administered each of hepatitis B vaccine. | Within 28 days after hepatitis B vaccination | 
| Geometric mean concentration of anti-hepatitis B virus surface antigen antibody | Geometric mean concentration of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL. | The 28th day after whole course of hepatitis B vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of hepatitis B virus perinatal transmission | To analyze the rate of hepatitis B virus perinatal transmission after whole course of hepatitis B vaccination. | The 28th day after whole course of hepatitis B vaccination | 
| Geometric mean concentration of anti-hepatitis B virus surface antigen antibody after the second dose of hepatitis B vaccination | Geometric mean concentration of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL. | The 28th day after the second of hepatitis B vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Immunogenicity, Vaccine, Hepatitis B