A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above

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 plannedfollow-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 ofinfluenza like cases;

• Have received any influenza vaccine within the past 12 months or have planned toreceive any influenza vaccine during the study period;

• Allergies to any components of the research vaccine, history of allergic reactionsto 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 acuteexacerbation of a chronic disease;

• Have used antipyretic or analgesic drugs or anti allergic drugs within 3 days beforevaccination;

• Have received any vaccine within 2 weeks prior to vaccination;

• Have received immunosuppressive therapy or other immunomodulatory drugs within 6months prior to receiving the experimental vaccine, For example, immunosuppressivedoses of glucocorticoids, monoclonal antibodies, thymosin, interferon, etc., orplanned to receive such treatment within one month after the first dose ofvaccination 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 ashypertension that cannot be controlled by drugs, diabetes that cannot be controlledby 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 ofseizures, epilepsy, encephalopathy, Guillain Barr é syndrome, psychiatric or familyhistory;

• Have a history of abnormal coagulation function and have been using anticoagulantswithin 3 weeks before vaccination;

• Patients with splenectomy, functional splenectomy, splenectomy, or other importantorgan resection or partial resection;

• Plan to move before the end of the study or leave the local area for a long timeduring 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.