Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT07144202
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-27
First Post:
2025-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Persistence of Immunity Following EV71 Vaccination
Sponsor:
Institute of Medical Biology, Chinese Academy of Medical Sciences
Organization:
Study Overview
Official Title:
Study on the Immunity Persistence Following Immunization With Enterovirus Type 71 Vaccine, Inactivated (Human Diploid Cell)
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 either 2 dose EV71 vaccine or placebo in the phase III clinical trial was selected to evaluate the EV71 immune levels 13 years after the primary vaccination.
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 participants (with 1100 in the immunogenicity group) were randomized in a 1:1 ratio to receive two doses EV71 vaccine or placebo on a 0-, 28-day schedule. Besides, an extended one-year and two year follow-up of this study was completed in 2013.
In this study, immunogenicity group participants from the phase III clinical trial was chosen as the studied subjects. A retrospective survey for the enrolled subjects involved with the history of HFMD and the extra vaccination of EV71 vaccine was conducted before blood collection. 3 ml venous blood were collected from each available subject for EV71 neutralizing antibody (NAb) testing. Since the unblinding was performed after the initial study completed, this study was an open-labelled detection for the persistence of the vaccine-induced EV71 NAb.
In this study, immunogenicity group participants from the phase III clinical trial was chosen as the studied subjects. A retrospective survey for the enrolled subjects involved with the history of HFMD and the extra vaccination of EV71 vaccine was conducted before blood collection. 3 ml venous blood were collected from each available subject for EV71 neutralizing antibody (NAb) testing. Since the unblinding was performed after the initial study completed, this study was an open-labelled detection for the persistence of the vaccine-induced EV71 NAb.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: