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| Name | Class |
|---|---|
| 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 |
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Subjects will be recruited and divided into 3 groups:
After immunization, the immunogenicity and safety of three different manufacturers will be compared and the data will be analyzed.
To evaluate the safety and immunogenicity of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchhun Institute of Biological Products Co., Ltd, we design this randomized, parallel controlled study. 450 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (Research Group 1, 2, and 3), each group assigned 150 subjects respectively.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Research Group 1 | Experimental | 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. |
|
| Research Group 2 | Active Comparator | 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. |
|
| Research Group 3 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun | Biological | Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun. 0.5ml per dose |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Seroconversion rate | Blood samples were collected before and 30 (+ 10) days after immunization. Antibody level and antibody seroconversion rate of HAV-IgG will detect in laboratory. The antibody seroconversion rate of HAV-IgG must maintain the baseline as the other two comparators' products. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Geometric Mean Titer (GMT) | Antibody GMT will detect in laboratory. The antibody GMT must maintain the baseline as the other two comparators' products. | 4 months |
| Adverse Events Incidence rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaobai Zhang | Shaanxi Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yangxian Center for Disease Control and Prevention | Hanzhong | Shaanxi | 723399 | China | ||
| Mianxian Center for Disease Control and Prevention |
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| Yangxian Center for Disease Control and Prevention | UNKNOWN |
| Peking University | OTHER |
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| Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang | Biological | 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 | Biological | 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. |
|
Analyse the numbers and rates of participants who suffered from adverse events following immunization.
| 6 months |
| Hanzhong |
| Shaanxi |
| 724200 |
| China |
| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| D014612 | Vaccines |
| D005612 | Freeze Drying |
| D015815 | Cell Adhesion Molecules |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D015925 | Cryopreservation |
| D014021 | Tissue Preservation |
| D016591 | Histocytological Preparation Techniques |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D011309 | Preservation, Biological |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
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