Can an EV71 vaccine protect older kids too?
NCT ID NCT07178522
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an inactivated EV71 vaccine (Envacgen®) in healthy children aged 6 to under 10 years and compares their immune response and safety to children aged 2 to under 6 years. Around 378 children will receive two shots 57 days apart. The goal is to see if the vaccine works as well in older children, potentially expanding its use against enterovirus 71, a cause of hand-foot-mouth disease.
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®)
- What this could lead to
- If successful, this could show that the EV71 vaccine works safely in children up to age 10, expanding protection against hand-foot-mouth disease caused by enterovirus 71.
- What could go wrong
- This is a small Phase 3 trial (378 participants) comparing age groups, not testing overall effectiveness. Results may not confirm broad protection or catch rare side effects.
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
-
About 378 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2025
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- 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 9 years
- 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 2 to \<10 years as established by medical history and clinical examination. 2. Subject and/or the subject's parent/guardian is able to understand and sign the ICF. Exclusion Criteria: 1. Has poor venous access. 2. Currently has a fever defined as ear/rectal temperature ≥ 38°C or axillary temperature ≥ 37.5 °C within 2 days before the time of planned vaccination. 3. Has had previously known exposure to EV71 or has received EV71 vaccine. 4. Has a history of herpangina or HFMD associated with enterovirus infection in the past 28 days before the date of planned study drug vaccination. 5. Has been diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic, or renal disorder. 6. Has a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component or any residual trace components such as formaldehyde of the Envacgen® vaccine. 7. Has used any investigational/nonregistered product (including drug, vaccine, or invasive medical device) within 28 days before study vaccination or plans to use any of them during the study period. 8. Has confirmed or suspected autoimmune disorder or immunodeficiency. 9. Has been administered or plans to be administered with any licensed live attenuated vaccine within 14 days before or after each study vaccination. 10. Has used immunoglobulins via intravenous route or any blood products within 11 months before vaccination or plans to use any of them during the study period. 11. Has received immunosuppressant, cytotoxic drug, corticosteroid (including prednisolone ≥ 0.5 mg/kg/day or equivalent), immunomodulator or acetylsalicylic acid for \> 14 days within 6 months before the first vaccination or plans to use any of them during the study period. (Inhaled and topical steroids are allowed). 12. Has any medical or psychiatric condition that is a contraindication to protocol participation based on the judgment of the Investigator.
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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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Chang Gung Medical Hospital Linkou
Taoyuan, Taiwan
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National Taiwan University Hospital
Taipei, Taiwan
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National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Taiwan