Clinical Trial

A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants and Children

Active, Not Recruiting Phase 3
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Record status
This record was last updated August 28, 2024 (before its estimated August 30, 2024 completion). Its status may not reflect the trial's current state.
Summary
The objectives of this study are to evaluate the EV71vaccine efficacy, immune response and safety profiles after two injections of the cell culture-based inactivated EV71 vaccine with adjuvant Al(OH)3 administrated in pediatric population aged 2 months to 6 years old.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-10-18; most recent amendment 2024-08-26.
Status change: Enrolling by Invitation → Active, Not Recruiting 2024-08-26
Trial Details
NCT Number NCT05099029
Lead Sponsor Enimmune Corporation
Conditions Enterovirus Infections
Enrollment 3,982 participants
Start Date 2018-06-27
Primary Completion 2024-08-30 (estimated)
Study Completion 2024-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-08-28