To evaluate the immunogenicity of administering one dose of influenza virus split vaccine (0.7mL/dose) to individuals aged 60 and above.
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.
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;
Parallel
Influenza virus split vaccine (0.7mL/vial)
Biological/VaccineInfluenza virus split vaccine, with a specification of 0.7mL/bottle, containing 60 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each Control: Influenza virus split vaccine.
Influenza virus split vaccine
Biological/VaccineInfluenza virus split vaccine, with a specification of 0.5mL/bottle, containing 15 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each.
Seroconversion rate
30 days after vaccination of all participants with the experimental vaccine or control vaccines, the HI antibody seroconversion rate against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Ratio of ≥1:40
30 days after vaccination of all participants with the experimental vaccine or control vaccines, the ratio of HI antibody titers ≥ 1:40 against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Geometric mean titer (GMT)
30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMT of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Geometric mean increase (GMI)
30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMI of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Solicited Adverse Events (AEs)
Adverse events defined by the protocol that occurred to the participant during 0-7 days after vaccination.
Unsolicited Adverse Events
Other adverse events that occurred among participants within 0-30 days after vaccination, in addition to the solicited adverse events.
Serious Adverse Events (SAEs)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
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