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

Sinovac

Status: Unknown

Conditions: Hand, Foot and Mouth Disease

Treatments: Biological: EV71 Inactivated Vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT05166044

EV71-SH-2020-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 12,500 estimated patients

Sex: All

Ages: 6 to 71 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

12,500 participants in 1 patient group

Safety group

Description:

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.

Treatment:

Biological: EV71 Inactivated Vaccine