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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT07302256
Eligibility Criteria:
Inclusion Criteria:
* Age over 60 years old, gender not limited, and able to provide legal identification;
* Volunteers voluntarily participate in the study and sign an informed consent form;
* Volunteers have the ability to understand research procedures, use thermometers, scales, and fill out diary cards as required, and can participate in all planned follow-up visits.
Exclusion Criteria:
* On the day of enrollment, the axillary temperature was ≥ 37.3 ℃;
* Those who have had influenza in the past 6 months or meet the definition of influenza like cases;
* Have received any influenza vaccine within the past 12 months or have planned to receive any influenza vaccine during the study period;
* Allergies to any components of the research vaccine, history of allergic reactions to the use of gentamicin sulfate, history of severe allergies to any vaccine/drug, or history of asthma;
* Suffering from a serious illness that prevents the completion of the entire study; Within 3 days prior to vaccination, there is an acute illness or an acute exacerbation of a chronic disease;
* Have used antipyretic or analgesic drugs or anti allergic drugs within 3 days before vaccination;
* Have received any vaccine within 2 weeks prior to vaccination;
* Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months prior to receiving the experimental vaccine, For example, immunosuppressive doses of glucocorticoids, monoclonal antibodies, thymosin, interferon, etc., or planned to receive such treatment within one month after the first dose of vaccination to full immunization, but local medication is allowed;
* Suffering from congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, or other autoimmune diseases;
* Suffering from serious chronic diseases, serious cardiovascular diseases, such as hypertension that cannot be controlled by drugs, diabetes that cannot be controlled by drugs or has serious complications, liver and kidney diseases, pulmonary edema, malignant tumors, etc;
* Have received blood or blood related products within the past 6 months;
* Individuals with progressive neurological disorders, including a history of seizures, epilepsy, encephalopathy, Guillain Barr é syndrome, psychiatric or family history;
* Have a history of abnormal coagulation function and have been using anticoagulants within 3 weeks before vaccination;
* Patients with splenectomy, functional splenectomy, splenectomy, or other important organ resection or partial resection;
* Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit;
* Currently or recently planning to participate in other clinical trials;
* Abnormal laboratory test indicators before vaccination;
* Researchers determine any situation that is not suitable for clinical trials.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT07302256
Study Brief:
Protocol Section:
NCT07302256