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| Name | Class |
|---|---|
| China National Biotec Group Company Limited | INDUSTRY |
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The purpose of this study is to evaluate the Immunogenicity and safety of the simultaneously vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV)
Main subjects:
The seroconversion rate for each antigen when EV71 is administrated with SIV
Secondary subjects:
The positive rate of antibody for each antigen when EV71 is administrated with SIV The safety for each antigen when EV71 is administrated with SIV
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 EV71 +SIV | Experimental | Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV) simultaneously with 28 days apart |
|
| Group 2 EV71 | Active Comparator | Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) with 28 days apart |
|
| Group 3 SIV | Active Comparator | Give 2 doses of seasonal influenza vaccine(SIV) simultaneously with 28 days apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV71 +SIV | Biological | Give 2 doses of EV71 +SIV, get 2 blood samples before the first dose and 28-43 days after the last dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| immunogenicity evaluation | The positive rate of antibody | change from baseline antibody concentration at 28 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| safety evaluation: The occurrence of adverse events | The occurrence of adverse events | up to 30 days after every injection |
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Inclusion Criteria:
Exclusion Criteria:
Known allergy to any constituent of the vaccine.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liandu Center for Disease Control and Prevention | Lishui | Zhejiang | China |
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| EV71 | Biological | Give 2 doses of EV71 , get 2 blood samples before the first dose and 28-43 days after the last |
|
| SIV | Biological | Give 2 doses of SIV , get 2 blood samples before the first dose and 28-43 days after the last |
|
| ID | Term |
|---|---|
| D006232 | Hand, Foot and Mouth Disease |
| ID | Term |
|---|---|
| D003384 | Coxsackievirus Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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