Clinical Trial of Subunit Influenza Vaccine (Adjuvant) in Chinese Population Aged 65 Years and Older

Exclusion Criteria

• •Axillary temperature \>37.0°C.
• •Confirmed influenza virus infection by laboratory test or self-test kit positive within the past 12 months.
• •Received any influenza vaccine (licensed or investigational) within the past 12 months or plans to receive any influenza vaccine during the study.
• •Known or suspected allergic to any component of the investigational vaccine.
• •A history of severe allergic reactions to any vaccines or medications (for example, but not limited to: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reaction (Arthus reaction)).
• •Congenital malformations or developmental disorders, and genetic defects or severe malnutrition.
• •History of convulsions or seizures, epilepsy, psychiatric disorders, or relevant family history.
• •Severe liver and kidney diseases, malignant tumors, various acute diseases, or being in the acute exacerbation stage of a chronic disease.
• •Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other immune-mediated/autoimmune diseases.
• •A history of asthma, unstable within the past two years requiring emergency treatment, hospitalization, intubation, or oral/intravenous corticosteroids.
• •Individuals who have received immunostimulant or immunosuppressant therapy within the past 6 months (continuously administered orally or via drip infusion for more than 14 days).
• •Suffering from severe cardiovascular diseases (e.g., heart disease, cor pulmonale, pulmonary edema).
• •Blood pressure ≥150/100 mmHg despite medication control.
• •History of live attenuated vaccine within 28 days prior to vaccination, or any other vaccine within 14 days prior to vaccination.
• •Diagnosed with progressive neurological diseases, or a history of Guillain-Barré syndrome.
• •Asplenia or functional asplenia, including splenectomy due to any reason, or resection/partial removal of other vital organs.
• •Received blood or blood-derived products within the past 6 months.
• •A diagnosed history of coagulation disorders (e.g., coagulation factor deficiencies, coagulopathies, platelet disorders).
• •Currently undergoing anti-tuberculosis treatment.
• •Clinically significant abnormalities in laboratory tests (blood biochemistry, blood routine and urine routine) as determined by the investigator.
• •Any condition that, in the opinion of the investigator, makes the participant unsuitable for this clinical trial.