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

• Conditions: Hand, Foot and Mouth Disease
• Interventions: Biological: EV71 Inactivated Vaccine

• Registration Number: NCT05166044
• Lead Sponsor: Sinovac Biotech Co., Ltd

Brief 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

Detailed Description

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.

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-21
• Study Start: 2022-01-04
• Primary Completion: 2022-06-04
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-11
• Study Completion: 2022-08-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Safety group	EV71 Inactivated Vaccine	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.

Primary Outcome Measures

Name	Time	Method
Safety index-The incidence of adverse reactions	From 0 to 30 days after vaccination	The incidence of adverse reactions 0-30 days after vaccination of EV71 vaccine combined immunization with other vaccines.
Safety index-incidence of local and systemic adverse reactions	From 0 to 3 days after vaccination	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)
Safety index-the incidence of local and systemic adverse reactions	From 0 to 14 days after vaccination	The incidence of local and systemic adverse reactions 0 to 14 days after each dose of EV71 vaccine combined with live attenuated vaccine
Safety index-Incidence of serious adverse reactions	From 0 to 30 days after vaccination	Incidence of serious adverse reactions 0 to 30 days after vaccination of EV71 vaccine combined immunization with other vaccines.

Trial Locations

Locations (6)

Minhang District Center for Disease Control and Prevention; 🇨🇳 Minhang, Shanghai, China

Baoshan District Center for Disease Control and Prevention; 🇨🇳 Baoshan, Shanghai, China

Jing'an District Center for Disease Control and Prevention; 🇨🇳 Jing'an, Shanghai, China

Putuo District Center for Disease Control and Prevention; 🇨🇳 Putuo, Shanghai, China

Qingpu District Center for Disease Control and Prevention; 🇨🇳 Qingpu, Shanghai, China

Xuhui District Center for Disease Control and Prevention; 🇨🇳 Xuhui, Shanghai, China