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| Name | Class |
|---|---|
| Wuhan Institute of Biological Products Co., Ltd | INDUSTRY |
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This study evaluates three batches consistency, immunity duration and safety of inactivated Enterovirus 71(EV-A71) vaccine(vero cell) post-marketing among children aged 6-35months in China.3000 subjects will be recruited in this study, of who 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 40L capacity reactor, other 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 150L capacity reactor. Vaccine wil be administrated according to a two doses of schedule given at day 0 and 28. Sample will be collected at day 0, day 56 and at month 13 after vaccinaiton.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the first batch vaccine producted by 40 L reactor | Experimental | 500 subjects will be randomly received the first batch vaccine producted by 40 L reactor |
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| the second batch vaccine producted by 40 L reactor | Experimental | 500 subjects will be randomly received the second batch vaccine producted by 40 L reactor |
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| the third batch vaccine producted by 40 L reactor | Experimental | 500 subjects will be randomly received the third batch vaccine producted by 40 L reactor |
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| the first batch vaccine producted by 150 L reactor | Experimental | 500 subjects will be randomly received the first batch vaccine producted by 150 L reactor |
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| the second batch vaccine producted by 150 L reactor | Experimental | 500 subjects will be randomly received the second batch vaccine producted by 150 L reactor |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor | Biological | 500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor |
| Measure | Description | Time Frame |
|---|---|---|
| Consistency of different batches for geometric mean titre(GMT) after vaccination | Consistency of different batches for GMT of EV-A71 neutralizing antibody on 56 day after vaccination | 56 days after vaccination |
| Incidence and severity of adverse reactions/adverse events after each dose | Incidence and severity of adverse reactions/adverse events within 1 month after each dose | 1 month after each dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of sever adverse events after vaccination | Incidence of sever adverse events within 13 months after vaccination | 13 months after vaccination |
| GMTof EV-A71 neutralizing antibody on day 56 after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for the second dose:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fengcai Zhu | Nanjing | China |
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| the third batch vaccine proudected by 150 L reactor | Experimental | 500 subjects will be randomly received the third batch vaccine producted by 150 L reactor |
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| The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor | Biological | 500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor |
|
| The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor | Biological | 500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor |
|
| The first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor | Biological | 500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor |
|
| The second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor | Biological | 500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor |
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| The third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor | Biological | 500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor |
|
GMTof EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
| 56 days after vaccination |
| Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination | Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs | 56 days after vaccination |
| Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination | Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs | 56 days after vaccination |
| Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination | Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs | 56 days after vaccination |
| GMTof EV-A71 neutralizing antibody on month 13 after vaccination | GMTof EV-A71 neutralizing antibody on month 13 after vaccination for different batchs | 13 months after vaccination |
| Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination | Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination for different batchs | 13 months after vaccination |
| 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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