Status:
RECRUITING
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
Lead Sponsor:
Medigen Vaccine Biologics Corp.
Conditions:
Enterovirus 71 Inactivated Vaccine
Eligibility:
All Genders
2-9 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
- Has been administered or plans to be administered with any licensed live attenuated vaccine within 14 days before or after each study vaccination.
- Has used immunoglobulins via intravenous route or any blood products within 11 months before vaccination or plans to use any of them during the study period.
- Has received immunosuppressant, cytotoxic drug, corticosteroid (including prednisolone ≥ 0.5 mg/kg/day or equivalent), immunomodulator or acetylsalicylic acid for \> 14 days within 6 months before the first vaccination or plans to use any of them during the study period. (Inhaled and topical steroids are allowed).
- Has any medical or psychiatric condition that is a contraindication to protocol participation based on the judgment of the Investigator.
Key Trial Info
Start Date :
June 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT07178522
Start Date
June 25 2025
End Date
July 1 2026
Last Update
September 17 2025
Active Locations (3)
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1
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Taiwan
2
National Taiwan University Hospital
Taipei, Taiwan
3
Chang Gung Medical Hospital Linkou
Taoyuan District, Taiwan