Clinical trial NCT05166044: Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization in Shanghai
Official title: Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization With Other Vaccines in Shanghai
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hand, Foot and Mouth Disease
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-12-21
Enrollment: 12500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Safety index-incidence of local and systemic adverse reactions
timeFrame: From 0 to 3 days after vaccination
measure: Safety index-the incidence of local and systemic adverse reactions
timeFrame: From 0 to 14 days after vaccination
measure: Safety index-The incidence of adverse reactions
timeFrame: From 0 to 30 days after vaccination
measure: Safety index-Incidence of serious adverse reactions
timeFrame: From 0 to 30 days after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Baoshan
country: China
facility: Baoshan District Center for Disease Control and Prevention
state: Shanghai
city: Jing'an
country: China
facility: Jing'an District Center for Disease Control and Prevention
state: Shanghai
city: Minhang
country: China
facility: Minhang District Center for Disease Control and Prevention
state: Shanghai
city: Putuo
country: China
facility: Putuo District Center for Disease Control and Prevention
state: Shanghai
city: Qingpu
country: China
facility: Qingpu District Center for Disease Control and Prevention
state: Shanghai
city: Xuhui
country: China
facility: Xuhui District Center for Disease Control and Prevention
state: Shanghai
Study officials:
affiliation: Shanghai Center for Disease Control and Prevention
name: Linlin Wu, Master
role: PRINCIPAL_INVESTIGATOR
References: