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| ID | Type | Description | Link |
|---|---|---|---|
| 2011L01488 | Other Identifier | China state food and drug adminstration |
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| Name | Class |
|---|---|
| Hebei Provincial Center for Diseases Control and Prevention | UNKNOWN |
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The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) that do not contains Preservative .
Influenza Virus Vaccine (Split Virion, Inactivated) that do not contains Preservative. HA contents 15μg/0.5ml per dose includ H1N1、H3N2 and B.
Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents 15μg/0.5ml per dose includ H1N1、H3N2 and B.
This is a randomized, blind phase 3 clinical trial. Total 1200 adults (above ages 36 months ) were selected, randomized to two groups [Influenza Virus Vaccine (Split Virion, Inactivated) and Inactivated Split Influenza Vaccine , each group n=600], adults in each group will be vaccinated with one dose of either Influenza Virus Vaccine (Split Virion, Inactivated) or Sanof IVV respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza Virus Vaccine | Experimental | Influenza Virus Vaccine(no Preservative ) 0.5ml intramuscular injections |
|
| Influenza Virus Vaccine(Preservative) | Experimental | Influenza Virus Vaccine(add Preservative ) 0.5ml intramuscular injections |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Virus Vaccine | Biological | Influenza Virus Vaccine 0.5ml intramuscular injections |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) | six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guoyang Liao, Ph. D | Institute of Medical Biology, Chinese Academy of Medical Sciences | Principal Investigator |
| Yuliang Zhao, MD | Hubei Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dingxing Center for Disease Prevention and Control | Shijiazhuang | Hebei | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28825515 | Derived | Jing-Xia G, Yu-Liang Z, Jin-Feng L, Shu-Zhen L, Guo-Yang L, Qi L. Safety and effectiveness assessment of 2011-2012 seasonal influenza vaccine produced in China: a randomized trial. Postgrad Med. 2017 Nov;129(8):907-914. doi: 10.1080/00325481.2017.1369133. Epub 2017 Sep 5. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| C478242 | vaxigrip |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Influenza Virus Vaccine(contains Preservative) | Biological | Influenza Virus Vaccine(contains Preservative)0.5ml intramuscular injections |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |