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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 378 (estimated)
• Sponsor: Medigen Vaccine Biologics Corp. · Industry
• Sex: All
• Age: 2 Years – 9 Years
• Healthy volunteers: Accepted

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.

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 .

Conditions

• Enterovirus 71 Inactivated Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Envacgen®	Subjects are to receive a 0.5 mL IM injection of Envacgen®. Study drug is administered on Day 1 and Day 57 of the study.

Timeline

• Start date: 2025-06-25
• Primary completion: 2026-02-01
• Completion: 2026-07-01
• First posted: 2025-09-17
• Last updated: 2025-09-17

Locations

3 sites across 1 country: Taiwan