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RECRUITING
NCT07178522
PHASE3

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

Sponsor: Medigen Vaccine Biologics Corp.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 9 Years

Study Type

INTERVENTIONAL

Enrollment

378

Start Date

2025-06-25

Completion Date

2026-07-01

Last Updated

2025-09-17

Healthy Volunteers

Yes

Interventions

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.

Locations (3)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Chang Gung Medical Hospital Linkou

Taoyuan District, Taiwan