Hand, Foot and Mouth Disease
Conditions
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.
Interventions
BIOLOGICALEV71 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.
Sponsors
Sinovac Biotech Co., Ltd
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 71 Months
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 |
Countries
China
Contacts
Primary ContactLinlin Wu, Master
Outcome results
None listed