Status:
ENROLLING_BY_INVITATION
Study on the Persistence of Immunity Following EV71 Vaccination
Lead Sponsor:
Institute of Medical Biology, Chinese Academy of Medical Sciences
Conditions:
Hand, Foot, and Mouth Disease
Hand, Foot, and Mouth Disease (HFMD)
Eligibility:
All Genders
Brief Summary
This is a thirteen-year follow-up study conducted as an extension of a Phase III clinical trial. In this study, a sub-cohort of volunteers who was eligible for enrollment and randomly administrated ei...
Detailed Description
The initial study was a randomized, double-blind, placebo-controlled phase III clinical trial conducted in children aged 6-71 months from Guilin region of Guangxi Province in 2012. A total of 12000 pa...
Eligibility Criteria
Inclusion
- Included in the immunogenicity group of initial studyand randomly into either vaccine (fulfilled the two doses vaccination following the protocol) or placebo group.
- Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the study's requirements.
Exclusion
- Had history of extra EV71 vaccination.
- Previous history of hand-foot-mouth disease.
- Participating in other research.
- Subjects with a hereditary bleeding tendency or coagulopathy, or a history of bleeding disorders.
- Investigators' Discretion: The final exclusion criterion is the discretion of investigators to determine whether a subject is suitable for participation in the study.
Key Trial Info
Start Date :
August 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 10 2026
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT07144202
Start Date
August 10 2025
End Date
March 10 2026
Last Update
August 27 2025
Active Locations (4)
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1
Lingchuan Center for Disease Control and Prevention
Guilin, Guangxi, China
2
Lipu Center for Disease Control and Prevention
Guilin, Guangxi, China
3
Xing'an Center for Disease Control and Prevention
Guilin, Guangxi, China
4
Yongfu Center for Disease Control and Prevention
Guilin, Guangxi, China