NCT07178522 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
| NCT ID | NCT07178522 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Medigen Vaccine Biologics Corp. |
| Condition | Enterovirus 71 Inactivated Vaccine |
| Study Type | INTERVENTIONAL |
| Enrollment | 378 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2026-02-01 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
Inclusion Criteria: 1. Healthy children aged 2 to \<10 years as established by medical history and clinical examination. 2. Subject and/or the subject's parent/guardian is able to understand and sign the ICF. Exclusion Criteria: 1. Has poor venous access. 2. 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. 3. Has had previously known exposure to EV71 or has received EV71 vaccine. 4. Has a history of herpangina or HFMD associated with enterovirus infection in the past 28 days before the date of planned study drug vaccination. 5. Has been diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic, or renal disorder. 6. 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. 7. Has used any investig