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| Name | Class |
|---|---|
| Xiamen University | OTHER |
| Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | INDUSTRY |
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This phase IV clinical study was designed to evaluate the safety and immunogenicity of the recombinant Hepatitis E vaccine(HecolinĀ®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 65 years of age at enrollment. The study volunteers will receive the 3 doses of HecolinĀ® administered intramuscularly according to a 0-1-6 month schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Participants in this arm are aged over 65 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(HecolinĀ®) at o,1,6 month. |
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| Immunogenicity Control Group | Active Comparator | Participants in this arm are aged beteen 18-65 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(HecolinĀ®) at o,1,6 month. |
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| Safety Control Group | No Intervention | Participants in this arm are aged over 65 years. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Hepatitis E Vaccine (Escherichia Coli) | Biological | Participants would intramuscularly receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) at 0, 1, 6 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions/events | Measure solicited local adverse reactions within 7 days after each vaccination; Measure solicited systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure serious adverse events occurred throughout the study | up to 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HEV antibody | Measure anti-HEV antibody in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine. | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhiping Chen | Zhejiang Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaihua Center for Disease Control and Prevention | Quzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31262585 | Derived | Yu XY, Chen ZP, Wang SY, Pan HR, Wang ZF, Zhang QF, Shen LZ, Zheng XP, Yan CF, Lu M, Chen B, Zheng Y, Zhang J, Lv HK, Huang SJ. Safety and immunogenicity of hepatitis E vaccine in elderly people older than 65 years. Vaccine. 2019 Jul 26;37(32):4581-4586. doi: 10.1016/j.vaccine.2019.04.006. Epub 2019 Jun 28. |
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| ID | Term |
|---|---|
| D016751 | Hepatitis E |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C577000 | hecolin |
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| D006505 |
| Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |