clinical trial · NCT07178522
A Study to Evaluate the Immunogenicity and Safety of an EV71 Vaccine (Envacgen®) in Children Aged 6 to <10 Years Compared to Children Aged 2 to <6 Years
Enterovirus 71 Inactivated VaccineEnvacgen®
brief summary
The purpose of this study is to assess the immunogenicity and safety of EV71 vaccine (Envacgen®) in Children Aged 6 to \<10 Years compared to Children Aged 2 to \<6 Years.
started
Jun 25, 2025
primary completion
Jul 31, 2026
completion
Oct 31, 2026
last updated
May 4, 2026
detailed description
This is a prospective, open-label, multi-center, phase 3 study. Participants will receive the first IM injection of study vaccine on Day 1 and will receive a second dose 56 days later. The last study visit is on Day 237 when participants will be contacted via telephone to assess for adverse events .
official title
A Prospective, Open-label, Multi-center, Phase 3 Study to Evaluate the Immunogenicity and Safety of an Inactivated EV71 Enterovirus Vaccine (Envacgen®) in Children Aged 6 to <10 Years Compared to Children Aged 2 to <6 Years
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol