Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT06734832
Eligibility Criteria:
Inclusion Criteria:
* Healthy children aged 6 to 71 months with no history of EV71 vaccination; or healthy children aged 24 to 71 months who have completed two doses of EV71 vaccine at least 6 months prior.
* Guardians who can understand and voluntarily sign the informed consent form.
* Willing and able to comply with all visit schedules, sample collections, vaccinations, and other research procedures.
* Provide proof of identity documents.
Exclusion Criteria:
* A known history of HFMD/HA.
* 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.
* Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection).
* Abnormal coagulation function (such as coagulation factor deficiencies, and platelet abnormalities).
* 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.
* Various acute diseases or exacerbations of chronic diseases within the last 3 days, or known or suspected active infections.
* Received a vaccine containing CA16 components.
* Received immunosuppressive or other immunomodulatory treatments for ≥14 days within the past 6 months (prednisone ≥2mg/kg/day, or its equivalent; local or inhaled corticosteroids excluded), cytotoxic therapy, or planning to receive such treatment during the trial.
* Received immunoglobulin or other blood products within the past 6 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.
* Received live attenuated vaccines or nucleic acid vaccines within the past 14 days, or subunit or inactivated vaccines within the past 7 days.
* Known allergy to any component of the investigational vaccine (inactivated EV71 virus, inactivated CA16 virus, aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, injectable water).
* On the day of the planned vaccination with the trial vaccine, there is a fever, with axillary temperature \> 37.0°C before vaccination;
* On the day of the planned vaccination with the trial vaccine, the physical examination is not qualified.
* Skin damage, inflammation, ulcers, rash, or scars at the target injection site that may interfere with vaccination or observation of local reactions.
* According to the investigator's judgment, participants have any other factors that make them unsuitable for participation in the clinical trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
71 Months
Study:
NCT06734832
Study Brief:
Protocol Section:
NCT06734832