Active — Not RecruitingNot Applicable

Long-Term Immunogenicity of Envacgen® in Children

Taiwan220 participantsStarted 2025-11-24

Plain-language 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.

Who can participate

Age range6 Years – 13 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants who have completed participation in study CT-EV-31s and have received protocol specified doses of EV71 vaccine or Placebo. * The participant and/or participant's parent/guardian is able to understand and sign the informed consent form. Exclusion Criteria: * The participant and/or participant's parent/guardian refuse to comply with the study procedures. * After completing the CT-EV-31s trial, participants who received any EV71 vaccine before participating in this study.

What they're measuring

Serum neutralizing antibody titer

Timeframe: Approximately 6 years after first dose of vaccination.

Seroprotection rate

Timeframe: Approximately 6 years after first dose of vaccination

Trial details

NCT IDNCT07568522

SponsorMedigen Vaccine Biologics Corp.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-02-16

View on ClinicalTrials.gov More Enterovirus 71 Human trials