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6-Year checkup: does the EV71 vaccine still shield kids?

NCT ID NCT07568522

Knowledge-focused Sponsor: Medigen Vaccine Biologics Corp. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows up on 220 children who received the EV71 vaccine (Envacgen®) or a placebo about 6 years ago. Researchers will measure antibody levels in the blood to see if protection against enterovirus 71, which causes hand-foot-mouth disease, has lasted. The goal is to understand the vaccine's long-term effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Inactivated EV71 enterovirus vaccine (Envacgen®) with adjuvant AlPO4
What this could lead to
If successful, this study could show that the EV71 vaccine provides long-lasting protection against hand-foot-mouth disease caused by enterovirus 71.
What could go wrong
This is an observational follow-up, not a new treatment test. It only measures antibody levels, not actual disease prevention, and results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

220 people

The number who actually took part.

Started

Nov 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects who have completed participation in study CT-EV-31s.

Ages

6 to 13 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

enterovirus infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Enterovirus 71 human

Contacts and locations

Locations

  • Chang Gung Medical Hospital Linkou

    Taoyuan, Taiwan

  • Mackay Memorial Hospital, HsincChu

    Hsinchu, Taiwan

  • Mackay Memorial Hospital, Taipei

    Taipei, Taiwan

  • National Taiwan University Hospital

    Taipei, Taiwan