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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

NCT07178522 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Enterovirus 71 Inactivated Vaccine

Interventions

BIOLOGICAL

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.

Sponsors & Collaborators

  • Medigen Vaccine Biologics Corp.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-25
Primary Completion
2026-07-31
Completion
2026-10-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07178522 on ClinicalTrials.gov