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

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

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

Study Overview

• Status: Recruiting
• Conditions: Hand, Foot and Mouth Disease
• Intervention / Treatment: Biological: EV71 Inactivated Vaccine

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 Type: Observational
• Enrollment (Anticipated): 12500

Contacts and Locations

• Study Contact: Name: Linlin Wu, Master; Phone Number: 13651849237; Email: wulinlin@scdc.sh.cn

Study Locations

• China
  • Shanghai
    • Baoshan, Shanghai, China, 201900
      • Recruiting
      • Baoshan District Center for Disease Control and Prevention
      • Contact: Xiaojun Li; Phone Number: 13641812162
    • Jing'an, Shanghai, China, 200040
      • Recruiting
      • Jing'an District Center for Disease Control and Prevention
      • Contact: Ping Yu; Phone Number: 13761361802
    • Minhang, Shanghai, China, 201100
      • Recruiting
      • Minhang District Center for Disease Control and Prevention
      • Contact: Liping Zhang; Phone Number: 18019709387
    • Putuo, Shanghai, China, 200333
      • Completed
      • Putuo District Center for Disease Control and Prevention
    • Qingpu, Shanghai, China, 201799
      • Completed
      • Qingpu District Center for Disease Control and Prevention
    • Xuhui, Shanghai, China, 200030
      • Recruiting
      • Xuhui District Center for Disease Control and Prevention
      • Contact: Jingyi liu; Phone Number: 13585770812

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Biological: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sinovac Biotech Co., Ltd
• Investigators: Principal Investigator: Linlin Wu, Master, Shanghai Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Actual): June 4, 2022
• Study Completion (Anticipated): August 10, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Stomatognathic Diseases; Enterovirus Infections; Picornaviridae Infections; Coxsackievirus Infections; Mouth Diseases; Foot-and-Mouth Disease; Hand, Foot and Mouth Disease
• Other Study ID Numbers: EV71-SH-2020-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No