Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization in Shanghai
NCT ID: NCT05166044
Last Updated: 2022-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
12500 participants
OBSERVATIONAL
2022-01-04
2022-08-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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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.
EV71 Inactivated Vaccine
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.
Interventions
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EV71 Inactivated Vaccine
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.
Eligibility Criteria
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Inclusion Criteria
* 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
6 Months
71 Months
ALL
Yes
Sponsors
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Sinovac Biotech Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Linlin Wu, Master
Role: PRINCIPAL_INVESTIGATOR
Shanghai Center for Disease Control and Prevention
Locations
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Baoshan District Center for Disease Control and Prevention
Baoshan, Shanghai Municipality, China
Jing'an District Center for Disease Control and Prevention
Jing’an, Shanghai Municipality, China
Minhang District Center for Disease Control and Prevention
Minhang, Shanghai Municipality, China
Putuo District Center for Disease Control and Prevention
Putuo, Shanghai Municipality, China
Qingpu District Center for Disease Control and Prevention
Qingpu, Shanghai Municipality, China
Xuhui District Center for Disease Control and Prevention
Xuhui, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xiaojun Li
Role: primary
Ping Yu
Role: primary
Liping Zhang
Role: primary
Jingyi liu
Role: primary
Other Identifiers
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EV71-SH-2020-01
Identifier Type: -
Identifier Source: org_study_id
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