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This study is an open clinical trial of the EV71 vaccine (Vero cell), Inactivated manufactured by Sinovac Research & Development Co.,Ltd.The purpose of this study is to evaluate the safety of EV71 vaccine (Vero cell), Inactivated co-administration with other vaccines
This study is an open clinical trial in children aged 6-71 months old. The purpose of this study is to evaluate the safety of EV71 vaccine (Vero cell), inactivated co-administration with other vaccines.The EV71 vaccine was manufactured by Sinovac Biotech Co.A total of 12500 subjects aged 6-71 months old were enrolled.All subjects received one dose of EV71 vaccine and one of other vaccines(such as MMR vaccine,encephalitis vaccine,mumps vaccine,inactivated poliomyelitis vaccine,influenza vaccine and so on ) at the same time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety group | All of the participants(N=12500) received one dose of EV71 vaccine and one of other vaccines(such as MMR vaccine,encephalitis vaccine,mumps vaccine,inactivated poliomyelitis vaccine,influenza vaccine and so on ) at the same time. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV71 Inactivated Vaccine | Biological | The EV71 vaccine was manufactured by Sinovac Biotech Co,And inactivated EV71 virus antigen was no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety index-incidence of local and systemic adverse reactions | Incidence of local and systemic adverse reactions 0 to 3 days after each dose of EV71 vaccine combined immunization with other vaccines (except live attenuated vaccines) | From 0 to 3 days after vaccination |
| Safety index-the incidence of local and systemic adverse reactions | The incidence of local and systemic adverse reactions 0 to 14 days after each dose of EV71 vaccine combined with live attenuated vaccine | From 0 to 14 days after vaccination |
| Safety index-The incidence of adverse reactions | The incidence of adverse reactions 0-30 days after vaccination of EV71 vaccine combined immunization with other vaccines. | From 0 to 30 days after vaccination |
| Safety index-Incidence of serious adverse reactions | Incidence of serious adverse reactions 0 to 30 days after vaccination of EV71 vaccine combined immunization with other vaccines. | From 0 to 30 days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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In this study,only children aged 6-71 months old who were judged by vaccination doctors to be eligible for vaccination and voluntary and self-funded completion of EV71 vaccine combined immunization with one of the other type I or II vaccines were enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linlin Wu, Master | Contact | 13651849237 | wulinlin@scdc.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Linlin Wu, Master | Shanghai Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baoshan District Center for Disease Control and Prevention | Recruiting | Baoshan | Shanghai Municipality | 201900 | China |
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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 |
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This study did not involve sample collection.Only adverse reactions/events at 3 days, 14 days and 30 days after vaccination of EV71 vaccine and the other vaccine were collected by face-to-face or telephone follow-up.
| Jing'an District Center for Disease Control and Prevention | Recruiting | Jing’an | Shanghai Municipality | 200040 | China |
|
| Minhang District Center for Disease Control and Prevention | Recruiting | Minhang | Shanghai Municipality | 201100 | China |
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| Putuo District Center for Disease Control and Prevention | Completed | Putuo | Shanghai Municipality | 200333 | China |
| Qingpu District Center for Disease Control and Prevention | Completed | Qingpu | Shanghai Municipality | 201799 | China |
| Xuhui District Center for Disease Control and Prevention | Recruiting | Xuhui | Shanghai Municipality | 200030 | China |
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| D014777 | Virus Diseases |
| D007239 | Infections |