Evaluation of the Safety and Immunogenicity of Hepatitis A Vaccine
NCT ID: NCT04612634
Last Updated: 2021-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
450 participants
INTERVENTIONAL
2020-11-12
2021-07-31
Brief Summary
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1. Hepatitis A（Live）Vaccine，Freeze-dried produced by Changchun Institute of Biological Products Co., Ltd
2. Hepatitis A（Live）Vaccine，Freeze-dried produced by Zhejiang Pukang Biotechnology Co., Ltd., and
3. Hepatitis A（Live）Vaccine，Freeze-dried produced by Institute of Medical Biology, Chinese Academy of Medical Sciences.
After immunization, the immunogenicity and safety of three different manufacturers will be compared and the data will be analyzed.
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Detailed Description
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All subjects are aged 18-24 months old.
150 subjects from Research Group 1 will be administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchhun Institute of Biological Products Co., Ltd. Blood samples are collected before vaccination and one month (30 days) later.
150 subjects from Research Group 2 will be administrated with one dose of Hepatitis A（Live）Vaccine，Freeze-dried produced by Zhejiang Pukang Biotechnology Co., Ltd. Blood samples are collected before vaccination and one month (30 days) later.
150 subjects from Research Group 3 will be administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. Blood samples are collected before vaccination and one month (30 days) later.
To evaluate the immunogenicity, we will detect and compare the seroconversion rates, and antibody geometric mean concentrations. The safety of all groups will be monitored as well.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Research Group 1
150 subjects are administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun Institute of Biological Products Co., Ltd. at the age of 18-24 months old, 0.5 ml each dose, respectively. Blood samples are collected before vaccination and one month (30 days) later.
Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun
Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun. 0.5ml per dose
Research Group 2
150 subjects are administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang Pukang Biotechnology Co., Ltd. at the age of 18-24 months old, 0.5 ml each dose, respectively. Blood samples are collected before vaccination and one month (30 days) later.
Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang
Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang. 0.5ml per dose.
Research Group 3
150 subjects are administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. at the age of 18-24 months old, 1.0 ml each dose, respectively. Blood samples are collected before vaccination and one month (30 days) later.
Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMS
Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, Chinese Academy of Medical Sciences. 1.0ml per dose.
Interventions
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Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun
Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun. 0.5ml per dose
Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang
Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang. 0.5ml per dose.
Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMS
Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, Chinese Academy of Medical Sciences. 1.0ml per dose.
Eligibility Criteria
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Inclusion Criteria
2. with informed consent signed by parent(s) or guardians;
3. parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;
4. subjects have not been vaccinated with any type of Hepatitis A vaccines;
5. subjects have no Hepatitis A disease and contraindication of vaccination;
6. subjects did not receive any vaccines within 14 days;
7. before joining this trial, subjects must be qualified and passed their medical history and clinical examinations, and axillary's temperature must be ≤37℃.
Exclusion Criteria
2. Allergic to any ingredient of vaccine or with allergy history to any vaccine;
3. Patients with immunodeficiency, in process of cancer treatment, immunosuppressive therapy (oral steroids) or HIV induced hypoimmunity, or in close contact with any family members who has congenital immune diseases;
4. Receive non-specific immunoglobulin within 1 month before recruitment;
5. Subjects with acute febrile diseases with body temperature \> 37.0 ℃ or infectious diseases;
6. Subjects with a history of thrombocytopenia or other coagulation disorders that may be contraindicated for hypodermic injection;
7. With known or suspected concurrent diseases include respiratory disease, acute infection or active chronic disease;
8. With severe cardiovascular diseases (Pulmonary heart disease, Pulmonary edema, hypertension cannot be controlled to normal range by drugs), liver and kidney diseases and diabetic complications;
9. Various infectious, suppurative or allergic dermatitis;
10. Other circumstances judged by investigators that are not suitable for this clinical trial.
18 Months
24 Months
ALL
Yes
Sponsors
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Changchun Institute of Biological Products Co., Ltd.
INDUSTRY
Shaanxi Provincial Center for Disease Control and Prevention
OTHER
Mianxian Center for Disease Control and Prevention
UNKNOWN
Yangxian Center for Disease Control and Prevention
UNKNOWN
Peking University
OTHER
China National Biotec Group Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Shaobai Zhang
Role: PRINCIPAL_INVESTIGATOR
Shaanxi Provincial Center for Disease Control and Prevention
Locations
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Yangxian Center for Disease Control and Prevention
Hanzhong, Shaanxi, China
Mianxian Center for Disease Control and Prevention
Hanzhong, Shaanxi, China
Countries
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Other Identifiers
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JGYM-2020-Ⅳ-01
Identifier Type: -
Identifier Source: org_study_id
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