Influenza
Conditions
Interventions
High-dose group of influenza virus subunit vaccine (adjuvanted):Administer 0.5ml of influenza virus subunit vaccine (adjuvanted), immunization schedule: Day 0.
Placebo group:Administer 0.5ml of placebo (0.9% sodium chloride solution) on Day 0.
Low-dose group of influenza virus subunit vaccine (adjuvanted):Administer 0.25ml of influenza virus subunit vaccine (adjuvanted), immunization schedule: Day 0.
Adjuvant group:Administer 0.5ml of adjuvant formulation alone on Day 0.
Sponsors
Hubei Provincial Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age at enrollment is >=65 years (including the day of the 65th birthday); 2. Participants voluntarily agree to participate in the trial and sign the informed consent form; 3. Participants are able to attend trial follow-ups as required by the protocol (with no plans for long-term absence or relocation away from the trial site); 4. Medically stable: Participants may have underlying chronic conditions, such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but the symptoms/signs are controlled. If medication is being taken, the dosage must have been stable for at least three weeks prior to vaccination.
Exclusion criteria
Exclusion criteria: 1. Axillary temperature >37.0°C; 2. Laboratory-confirmed or self-test kit positive influenza infection within the past 12 months; 3. Receipt of any influenza vaccine (registered or investigational) within the past 12 months or planned receipt of any influenza vaccine during the trial period; 4. Known or suspected allergy to any component of the investigational vaccine; 5. History of severe allergy to any vaccine or drug (e.g., but not limited to: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reaction (Arthus reaction)); 6. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; 7. History of convulsions or seizures, epilepsy, personal or family history of psychiatric disorders; 8. Severe liver or kidney disease, malignancy, any acute illness, or acute exacerbation of a chronic disease; 9. Diagnosed congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other immune-mediated/autoimmune diseases; 10. History of asthma, with unstable conditions requiring emergency treatment, hospitalization, intubation, or oral/intravenous corticosteroids within the past two years; 11. Receipt of immunostimulant or immunosuppressant therapy within the past 6 months (continuous oral or intravenous administration for more than 14 days); 12. Severe cardiovascular diseases (e.g., heart disease, cor pulmonale, pulmonary edema); 13. Blood pressure >=150/100 mmHg after medication control; 14. Receipt of live attenuated vaccines within 28 days prior to vaccination, or receipt of other vaccines within 14 days prior to vaccination; 15. Progressive neurological disorders or history of Guillain-Barré syndrome; 16. Asplenia, functional asplenia, or any condition resulting in asplenia or splenectomy; or removal or partial removal of other vital organs; 17. Receipt of blood or blood-related products within the past 6 months; 18. Diagnosed history of coagulation disorders (e.g., coagulation factor deficiencies, coagulopathies, platelet abnormalities); 19. Ongoing anti-tuberculosis treatment; 20. Abnormal laboratory test results (e.g., complete blood count, blood biochemistry, urinalysis) deemed clinically significant by the investigator; 21. Any other condition considered by the investigator as unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Serious Adverse Events (SAE) and Serious Adverse reactions within 12 months after vaccination.;Adverse reactions and adverse events;The incidence of abnormal laboratory parameters (blood biochemistry, hematology, and urinalysis) was recorded for 3 days post-vaccination.; | — |
Countries
China
Contacts
Public ContactYeqing Tong
Hubei Provincial Center for Disease Prevention and Control
Outcome results
None listed