Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization in Shanghai

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization With Other Vaccines in Shanghai

Conditions
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Hand, Foot and Mouth Disease

Intervention / Treatment
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* Biological: EV71 Inactivated Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6 months ≤ Age of enrollment ≤71 months; Voluntary and self-funded completion of EV71 vaccine combined immunization with one of the other type I or II vaccines; The subject and/or guardian can understand and voluntarily sign the informed consent form; Subjects and their legal guardians are able to attend follow-up visits and follow all study procedures (such as cooperating in completing safety observation notes). Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 71 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Safety group<br>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. | Biological: EV71 Inactivated Vaccine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |