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

Sinovac Biotech Co., Ltd12,500 enrolled

Overview

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

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

12,500

Conditions

Hand, Foot and Mouth Disease

Interventions

EV71 Inactivated VaccineBIOLOGICAL

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

Sex: ALLMin age: 6 MonthsMax age: 71 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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: \-

Locations (6)

Baoshan District Center for Disease Control and Prevention

Baoshan, Shanghai Municipality, China

RECRUITING

Jing'an District Center for Disease Control and Prevention

Jing’an, Shanghai Municipality, China

RECRUITING

Minhang District Center for Disease Control and Prevention

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: From 0 to 30 days after vaccination

Central Contacts

Linlin Wu, Master

CONTACT

13651849237 wulinlin@scdc.sh.cn

Data from ClinicalTrials.gov

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