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

Hand, Foot and Mouth Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05166044
• Other study ID #: EV71-SH-2020-01
• Status: Recruiting
• Start date: January 4, 2022
• Est. completion date: August 10, 2022

Study information

• Verified date: December 2021
• Source: Sinovac Biotech Co., Ltd
• Contact: Linlin Wu, Master
• Phone: 13651849237
• Email: wulinlin[@]scdc.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12500
• Est. completion date: August 10, 2022
• Est. primary completion date: June 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 71 Months

Eligibility

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:

-

Related Conditions & MeSH terms

• Hand, Foot and Mouth Disease
• Mouth Diseases

Intervention

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.

Locations

Country	Name	City	State
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	Minhang District Center for Disease Control and Prevention	Minhang	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

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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