New vaccine aims to protect against common childhood illness
NCT ID NCT07326878
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a new vaccine designed to protect against hand, foot, and mouth disease caused by two common viruses. About 144 healthy volunteers aged 6 months to 59 years will receive either the vaccine or a placebo. The main goal is to check safety and see how well the vaccine triggers an immune response.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 144 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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6 months to 59 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: * Age Requirement: volunteers aged 6 months and 59 years. * Provision of Legal Identification: volunteers and their legal guardians or appointed representatives must provide valid legal identification documents. * Informed Consent: participants, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time. * 6\~23months old: term delivery (gestational week 37 weeks \~ 42 weeks at birth), 2500g ≤ birth weight ≤ 4000g. * Requirements for contraception: agree to take contraception actions in 12 months. * Temperature Requirement: axillary body temperature is less than 37.3°C. Exclusion Criteria: Subjects meeting any of the following exclusion criteria will be not eligible for enrollment. * Subjects who have been allergic to any component of the vaccine in the past, or have any history of vaccine allergy or suspected allergy or other serious adverse reactions, such as urticaria, respiratory distress, and angioedema. * History of taking administration of a non-SARS-CoV-2 inactivated vaccine or subunit vaccine within 7 days before enrollment, or any live attenuated vaccine or SARS-CoV-2 vaccine within 14 days before enrollment. * Subjects with convulsion, epilepsy, encephalopathy, psychiatric history or family history. * Known to have serious congenital malformations, developmental disorders, genetic defects or abnormal growth and development, or clinically diagnosed serious chronic diseases, including but not limited to neurological, cardiovascular, blood and lymphatic system, immune system, kidney, liver, gastrointestinal, respiratory system, metabolism and bone diseases and a history of malignant tumors. * Subjects are acutely ill or in the acute phase of a chronic illness within 3 days before vaccination. * Subjects with a hereditary bleeding tendency or coagulopathy, or a history of bleeding disorders. * Subjects who intolerance to venipuncture and with a history of needle- or blood-induced syncope. * History of surgical removal of the spleen or other vital organs for any reason. * Donation or loss of blood (≥400 mL), receipt of blood products, or receipt of blood transfusion within the 3 months before enrollment. * Use of any investigational or unregistered product (drug, vaccine, biological product, or device) other than a study vaccine within 3 months before enrollment or planned for use during the study. * Have treatment with immunosuppressive agents within 6 months before enrollment, such as long-term systemic glucocorticoid therapy (e.g., prednisone or a similar drug for more than 2 consecutive weeks within 6 months), but topical use (e.g., ointments, eye drops, inhalers, or nasal sprays) was allowed. Topical use should not exceed the recommended dose on the label or have any signs of systemic exposure. * History of any EV71 antigen-containing vaccination, whether commercially available or investigational. * Subjects with history of hand, foot, and mouth disease. * Subjects with abnormal vital signs with clinical significance. * Subjects who do not meet the criteria for good health based on comprehensive physical examination, including: (1) abnormal vital signs with clinical significance; (2) clinical laboratory testing shows laboratory abnormalities and with clinical significance (applicable only to subjects aged 2 years and above). * Have been diagnosed with an infectious disease that may interfere with the conduct or completion of the study, such as active tuberculosis, viral hepatitis, human immunodeficiency virus (HIV) infection, etc. * Females with positive pregnancy test results. * Females who are lactating, or subjects who plan to conceive or to donate sperm or ova from the time of signing the informed consent form until 12 months after completion of the full vaccination schedule (applicable only to subjects aged 18 to 59 years). * Subjects with a history of abnormal birth delivery, birth asphyxia, neurological impairment, or clinically diagnosed pathological jaundice (applicable only to subjects aged 6 to 23 months). * Subjects deemed by the investigator to be unsuitable for participation in the study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.