Active — Not RecruitingPhase 3

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

Taiwan378 participantsStarted 2025-06-25

Plain-language 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.

Who can participate

Age range2 Years – 9 Years

SexALL

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Inclusion criteria

✓. Healthy children aged 2 to \<10 years as established by medical history and clinical examination.
✓. Subject and/or the subject's parent/guardian is able to understand and sign the ICF.

Exclusion criteria

✕. Has poor venous access.
✕. Currently has a fever defined as ear/rectal temperature ≥ 38°C or axillary temperature ≥ 37.5 °C within 2 days before the time of planned vaccination.
✕. Has had previously known exposure to EV71 or has received EV71 vaccine.
✕. Has a history of herpangina or HFMD associated with enterovirus infection in the past 28 days before the date of planned study drug vaccination.
✕. Has been diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic, or renal disorder.
✕. Has a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component or any residual trace components such as formaldehyde of the Envacgen® vaccine.
✕. Has used any investigational/nonregistered product (including drug, vaccine, or invasive medical device) within 28 days before study vaccination or plans to use any of them during the study period.
✕. Has confirmed or suspected autoimmune disorder or immunodeficiency.

What they're measuring

Immunogenicity of Envacgen®

Timeframe: Day 1 to 28 days after the second vaccination.

Incidence of Adverse Events(AEs) [Safety]

Timeframe: Day 1 to 28 days after the second vaccination.

Trial details

NCT IDNCT07178522

SponsorMedigen Vaccine Biologics Corp.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-31

View on ClinicalTrials.gov More Enterovirus 71 Inactivated Vaccine trials