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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.
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
Conditions
Interventions
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