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Long-Term Immunogenicity of Envacgen® in Children
Sponsor: Medigen Vaccine Biologics Corp.
Summary
This study is designed to evaluate the long-term antibody titers of Envacgen® approximately 6 years after the first vaccination dose in participants who were aged 2 months to \<6 years at the time of enrollment in the CT-EV-31s study.
Official title: Extension Study of Protocol CT-EV-31s to Examine the Long-Term Immunogenicity After Receiving Inactivated EV71 Enterovirus Vaccine (Envacgen®) in Children
Key Details
Gender
All
Age Range
6 Years - 13 Years
Study Type
OBSERVATIONAL
Enrollment
220
Start Date
2025-11-24
Completion Date
2026-07-31
Last Updated
2026-05-05
Healthy Volunteers
Yes
Conditions
Interventions
EV71 vaccine
EV71 vaccine with Adjuvant AlPO4 and the placebo (Adjuvant AlPO4 only) were randomly administrated to subject in CT-EV-31s study
Locations (4)
Mackay Memorial Hospital, HsincChu
Hsinchu, Taiwan
Mackay Memorial Hospital, Taipei
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Medical Hospital Linkou
Taoyuan, Taiwan