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| Name | Class |
|---|---|
| Shaanxi Provincial Center for Disease Control and Prevention | OTHER |
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Hepatitis A is the most prevalent hepatitis which account for approximately 45% . The susceptible population is Children and adolescence, also the morbidity in adult presented rising trend in recent years. Therefore, vaccination of Hepatitis A Vaccine play an important role in National Immunisation Program(China). The aim of this experiment is to verify the effects of experimental group non-inferior than control group. The experiment methods is compared the difference of seroconversion rate and Antibody geometric mean titer (GMT)between experimental and control Hepatitis A Vaccines. In addition, evaluating the safety of two Hepatitis A Vaccines in 18-24 months Chinese Children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Group 1 is experimental group which used the Hepatitis A Vaccine product by Changchun Institute of Biological Co.,Ltd |
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| Group 2 | Active Comparator | Group 2 is control group which used the Hepatitis A Vaccine product by Changchun Changsheng Life Sciences Limited |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatitis A Vaccine | Biological | Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result . |
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| Measure | Description | Time Frame |
|---|---|---|
| To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine. | Collecting serum of subjects before, after vaccination immediately and after 35-42 days, and testing the quantity of antibody. Compared the difference of antibody quantity between two types Hepatitis A Vaccine and the Multiple of antibody based on the time. | 35-42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Observation 30 minutes after vaccination and give guardians feedback forms to record untoward effects, collecting the forms after 1 month when the subjects conduct the third time blood collection. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanxi Provincial Center for Disease Control and Prevention | Yuncheng | Shanxi | China |
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| Label | URL |
|---|---|
| The reference 6 | View source |
| The reference 8 | View source |
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Based on the literature public progress.
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| ID | Term |
|---|---|
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D045424 |
| Complex Mixtures |