New vaccine aims to shield kids from hand, foot, and mouth disease
NCT ID NCT07611513
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new vaccine designed to prevent hand, foot, and mouth disease (HFMD) and herpangina in children aged 6 months to 5 years. About 6,000 healthy children will receive either the vaccine or a placebo to see if it safely protects against four common virus types that cause these illnesses. The goal is to find a way to reduce outbreaks and keep children healthy.
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 6,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
May 2026
An estimate. Start dates often move.
- Expected to finish
-
Sep 2028
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.
- Ages
-
6 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 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 6 to 71 months. 2. Guardians who can understand and voluntarily sign the informed consent form 3. Willing and able to comply with all visit schedules, sample collection, vaccinations, and other trial procedures。 4. Provide legal identification for the participant and their guardian Exclusion Criteria: 1. A known history of HFMD/HA 2. Uncontrolled chronic diseases or a history of severe illnesses, including but not limited to cardiovascular diseases, blood disorders, liver or kidney diseases, digestive system diseases, respiratory system diseases, malignant tumors, or a history of major functional organ transplantation. 3. Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection). 4. Abnormal coagulation function (such as coagulation factor deficiencies,and platelet abnormalities). 5. Suffering from/having a history of severe neurological diseases (epilepsy, convulsions, or seizures \[excluding a history of febrile seizures\]) ,psychiatric disorders, or a family history of psychiatric disorders 6. Various acute diseases or exacerbations of chronic diseases within the last 3 days. 7. Having been vaccinated with a vaccine containing any of the components EV71, CA16, CA10, CA6. 8. Having received ≥14 days of immunosuppressive or other immunomodulatory treatment (prednisone ≥2mg/kg/day, or its equivalent; local or inhaled corticosteroids excluded) within the past 6 months, or cytotoxic treatment, or planning to receive such treatment during the trial. 9. Having received immunoglobulin or other blood products(excluding hepatitis B immunoglobulin) within the past 6 months, or planning to receive such treatment during the trial. 10. Having received other investigational drugs or vaccines within the past 30 days, or planning to receive such drugs or vaccines during the trial. 11. Having received live attenuated vaccines or nucleic acid vaccines within the past 14 days, or subunit or inactivated vaccines within the past 7 days. 12. Known allergy to any component of the investigational vaccine (inactivated EV71 virus, inactivated CA16 virus, , inactivated CA10 virus,, inactivated CA6 virus,aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, injectable water). 13. On the day of planned vaccination with the investigational vaccine, having an axillary temperature ≥37.3°C before vaccination, or other vital sign measurements outside the normal range,or the physical examination is not qualified. 14. According to the investigator's judgment, participants have any other factors that make them unsuitable for participation in the clinical trial.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hand, foot, and mouth disease (HFMD) are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
5 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Anhui Provincial Center for Disease Control and Prevention
Hefei, Anhui, China
-
Fujian Provincial Center for Disease Control and Prevention
Fujian, China
-
Henan Provincial Center for Disease Control and Prevention
Henan, China
-
Hubei Provincial Center for Disease Control and Prevention
Hubei, China
-
Sichuan Provincial Center for Disease Control and Prevention
Sichuan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.