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New vaccine aims to tackle two viruses behind hand, foot, and mouth disease

NCT ID NCT06063057

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

744 people

The number who actually took part.

Started

Sep 2023

Finished

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

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: * 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

  • 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.