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This study evaluates the safety,three batches consistency and immunity duration of the post-marketing inactivated Enterovirus Type 71 (EV71) vaccine in children aged 6-71 months.This study has two groups:safety observation group and immunogenicity observation group.20000 subjects will receive 2 doses vaccines and be observed for safety among 2 epidemic cycles of HFMD.In the immunogenicity observation group, 900 subjects will be randomly received 3 batches vaccines(2 doses),and blood sampled at days 0 and 56.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 300 subjects receive the first batch vaccine | Experimental | 300 subjects will be randomly received the first batch vaccine |
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| 300 subjects receive the second batch vaccine | Experimental | 300 subjects will be randomly received the second batch vaccine |
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| 300 subjects receive the third batch vaccine | Experimental | 300 subjects will be randomly received the third batch vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the first batch vaccine | Biological |
| ||
| the second batch vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Rate of Adverse reactions of Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months. | Adverse reactions associated with vaccine will be observed in Children Aged 6-71 Months after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy. | 24 months |
| Evaluate the seroconversion rate of EV71 antibodies in serum after vaccination. | The seroconversion rate of EV71 antibodies will be evaluated in serum at days 0 and 56. | 56 days |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for the first dose:
Exclusion Criteria for the second dose:
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| Biological |
|
| the third batch vaccine | Biological |
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| 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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