Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization in Shanghai
1 other identifier
observational
12,500
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2021
CompletedFirst Posted
Study publicly available on registry
December 21, 2021
CompletedStudy Start
First participant enrolled
January 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2022
CompletedJuly 11, 2022
December 1, 2021
5 months
December 8, 2021
July 7, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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
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
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
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
Study Arms (1)
Safety group
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.
Interventions
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 Criteria
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.
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Baoshan District Center for Disease Control and Prevention
Baoshan, Shanghai Municipality, 201900, China
Jing'an District Center for Disease Control and Prevention
Jing’an, Shanghai Municipality, 200040, China
Minhang District Center for Disease Control and Prevention
Minhang, Shanghai Municipality, 201100, China
Putuo District Center for Disease Control and Prevention
Putuo, Shanghai Municipality, 200333, China
Qingpu District Center for Disease Control and Prevention
Qingpu, Shanghai Municipality, 201799, China
Xuhui District Center for Disease Control and Prevention
Xuhui, Shanghai Municipality, 200030, China
Biospecimen
This study did not involve sample collection.Only adverse reactions/events at 3 days, 14 days and 30 days after vaccination of EV71 vaccine and the other vaccine were collected by face-to-face or telephone follow-up.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linlin Wu, Master
Shanghai Center for Disease Control and Prevention
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2021
First Posted
December 21, 2021
Study Start
January 4, 2022
Primary Completion
June 4, 2022
Study Completion
August 10, 2022
Last Updated
July 11, 2022
Record last verified: 2021-12