Can a new shot stop a childhood virus that can attack the brain?

NCT ID NCT05099029

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing an inactivated enterovirus 71 (EV71) vaccine in healthy infants and children aged 2 months to 6 years. The trial aims to see if two shots of the vaccine can prevent hand, foot and mouth disease caused by EV71 and reduce severe complications like neurologic problems and hospitalization. About 4,000 children will receive either the vaccine or a placebo, and researchers will track infections and immune responses.

What this could mean

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

Active substance
an adjuvanted, inactivated enterovirus 71 (EV71) vaccine
What this could lead to
If it works, this vaccine could protect young children from hand, foot and mouth disease and its severe complications, including neurologic and heart problems.
What could go wrong
The vaccine may not prevent enough infections, or protection may fade. As with any vaccine, some children may have side effects, though serious reactions are rare.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

3,982 people

The number who actually took part.

Started

Jun 2018

Finished

Jul 2024

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.

Ages

2 to 71 months

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: 1. Healthy children aged from 2 months to 6 years old (i.e. \>= 2 months old and \< 7 years old) at the time of first vaccination. 2. Subject's guardians are able and willing to comply with study procedures and provide the signed informed consent. 3. Subject is able and can comply with the requirements of the protocol. 4. Subject with body temperature \<= 38℃. Exclusion Criteria: 1. Subject with previous known Enterovirus 71 (EV71) infection or investigational EV71 vaccination. 2. Subject with a history of herpangina, hand-foot-mouth disease, and acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 30 days. 3. Subject with a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 4. Subject under 2 years old with gestation \<34weeks or a birth weight \<2200g. 5. History of epilepsy, seizures or non-febrile convulsions that may affect subject participation in the study in the opinion of the investigator. 6. Severe malnutrition or dysgenopathy at the screening visit. 7. Major congenital defects or serious chronic illness, including perinatal brain damage at the screening visit. 8. Subject diagnosed of having autoimmune disease (e.g., celiac disease, type I diabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile idiopathic arthritis (JIA), immune (or idiopathic) thrombocytopenia purpura) that may affect subject participation in the study in the opinion of the investigator. 9. Bleeding disorder diagnosed by a doctor or significant bruising or hemostatic difficulties with IM injections or blood draws. 10. Any acute febrile illness 3 days prior to administrating the first vaccination. 11. Use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during Visit 1 to Visit 4 (Day 0 to Day 196). 12. Administration of any vaccine within 14 days prior to each study vaccination. 13. Use of immunoglobulins or any blood products within 3 months prior to vaccination. 14. Chronic administration (defined as \> 14 day of continuous use) of systemic immunosuppressants, other systemic immunomodulators, or systemic corticosteroids within 6 months prior to vaccination. 15. Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives. 16. Subject with any confirmed or suspected immunodeficiency.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Changhua Christian Hospital

    Changhua, Taiwan

  • China Medical University Hospital

    Taichung, Taiwan

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, Taiwan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • National Taiwan University Hospital HsinChu Branch

    Hsinchu, Taiwan

  • Nguyen Dinh Chieu Hospital

    An Hội, Vinh Long, Vietnam

  • Taichung Veterans General Hospital

    Taichung, Taiwan

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • Vinh Long City Health Center

    Long Châu, Vinh Long, Vietnam

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