UnknownNot Applicable

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

China12,500 participantsStarted 2022-01-04

Plain-language summary

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

Who can participate

Age range6 Months – 71 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: \-

What they're measuring

Safety index-incidence of local and systemic adverse reactions

Timeframe: From 0 to 3 days after vaccination

Safety index-the incidence of local and systemic adverse reactions

Timeframe: From 0 to 14 days after vaccination

Safety index-The incidence of adverse reactions

Timeframe: From 0 to 30 days after vaccination

Safety index-Incidence of serious adverse reactions

Timeframe: From 0 to 30 days after vaccination

Trial details

NCT IDNCT05166044

SponsorSinovac Biotech Co., Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-06-04

Contact for this trial

Linlin Wu, Master

13651849237 wulinlin@scdc.sh.cn

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