Can a new shot stop a childhood virus that can attack the brain?
NCT ID NCT05099029
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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3,982 people
The number who actually took part.
- Started
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Jun 2018
- Finished
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Jul 2024
- Lead sponsor
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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
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2 to 71 months
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Changhua Christian Hospital
Changhua, Taiwan
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China Medical University Hospital
Taichung, Taiwan
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Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
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National Taiwan University Hospital
Taipei, Taiwan
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National Taiwan University Hospital HsinChu Branch
Hsinchu, Taiwan
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Nguyen Dinh Chieu Hospital
An Hội, Vinh Long, Vietnam
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Taichung Veterans General Hospital
Taichung, Taiwan
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Taipei Veterans General Hospital
Taipei, Taiwan
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Vinh Long City Health Center
Long Châu, Vinh Long, Vietnam
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