A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above
Trial Parameters
Brief Summary
This is a randomized, blinded, controlled phase I clinical trial with a total of 120 participants aged ≥ 60 years. Experimental group: Influenza virus split vaccine (0.7mL/vial), control group 1: Influenza virus split vaccine, control group 2: placebo group. The three groups were recruited at a ratio of 1:1:1, and 40 individuals were randomly vaccinated in each group. Each person was injected with one dose of the vaccine into the deltoid muscle of the upper arm. Participants in each study group are required to undergo laboratory indicator tests before and on the 4th day after vaccination.
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 vac