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New vaccine aims to tackle two viruses behind hand, foot, and mouth disease
NCT ID NCT06063057
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This clinical trial tested a new vaccine designed to protect against two viruses (EV71 and CA16) that cause hand, foot, and mouth disease and herpangina. The study involved 744 healthy adults and children, including kids as young as 6 months. Researchers checked the vaccine's safety and how well it triggers an immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bivalent Enterovirus Vaccine (Vero Cell), Inactivated
- What this could lead to
- If successful, this vaccine could help prevent hand, foot, and mouth disease and herpangina caused by two common viruses (EV71 and CA16).
- What could go wrong
- This is an early-phase trial (Phase I/II) focused on safety and immune response, not yet proven to prevent disease. Results may not lead to a licensed vaccine.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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744 people
The number who actually took part.
- Started
-
Sep 2023
- Finished
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Mar 2026
- 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 months to 59 years
- Sex
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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: * Healthy participants aged 18-59 years, 6-12 years, and 6-71 months. * Participants and/or their guardians can understand and voluntarily sign the informed consent form (participants aged 8-12 years require dual signatures from both participants and their guardians). * Willing and able to comply with all visit schedules, sample collection, vaccine administration, and other trial procedures. * Provide legal identification of the participants and/or their guardians. Exclusion Criteria: * History of hand, foot, and mouth disease or EV71 vaccination. * Known severe allergy to the vaccine or vaccine components, such as urticaria, respiratory distress, and angioedema. * Congenital abnormalities or developmental disorders, genetic defects (such as Down syndrome, thalassemia, or G6PD deficiency), severe malnutrition, etc. * Based on medical history and physical examination, the presence of severe chronic diseases, severe cardiovascular diseases, uncontrolled hypertension or diabetes, liver or kidney diseases, etc. * Based on medical history and physical examination, the presence of autoimmune diseases, immunodeficiency diseases, and/or blood diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, thyroidectomy, autoimmune thyroid disease, any form of malignancy, asplenia, functional asplenia). * Based on medical history and physical examination, abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or obvious bruising or bleeding disorders. * Based on medical history and physical examination, the presence of severe neurological diseases (epilepsy, convulsions, or seizures), mental illness, or corresponding family history. * Long-term use (more than 14 days) of corticosteroids or other immunosuppressive agents (excluding corticosteroid sprays for allergic rhinitis and surface corticosteroid treatment for acute non-complicated dermatitis) or cytotoxic therapy or planning to receive such treatment during the trial. * History of long-term alcohol abuse or drug abuse. * Females who are breastfeeding, pregnant, or planning to become pregnant within 90 days, or females with positive pregnancy test results. Note: male participants whose spouse plans to become pregnant within 90 days are also included. * Received immunoglobulin and/or other blood products in the past 3 months or planning to receive such treatment during the trial. * Received other investigational drugs or vaccines within the past 30 days or planning to receive such drugs or vaccines during the trial. * Vaccinated with attenuated live vaccines within the past 14 days or subunit or inactivated vaccines within the past 7 days. * Suspected or confirmed fever within 72 hours before vaccination or axillary temperature \>37.0℃ on the day of vaccination. * Clinical laboratory testing shows laboratory abnormalities beyond the reference range and with clinical significance (applicable only to Phase I clinical trials for adults/6-12-year-old children/24-71-month-old children): A. Complete blood count: white blood cell count, hemoglobin, platelet count.B. Blood biochemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), creatinine (CR), fasting blood glucose (Glu).C. Urine routine: urine protein (PRO). * Any acute illness (with or without fever) or exacerbation of chronic illness within the past 7 days. * According to the investigator's judgment, there are any other factors that make the participant unsuitable for participation in the clinical trial.
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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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Dayao County Center for Disease Control and Prevention
Chuxiong, Yunnan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.