This clinical trial adopts a seamless design of phase I/II, conducted in two stages: phase I and phase II. Phase I is the age/dose ramp up stage, and phase II is the dose expansion stage.The purpose of this clinical trial is to evaluate the safety and tolerability of different doses of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant,explore the immunogenicity of the vaccine, and determine the appropriate dose for later clinical trials of this product.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. When signing the informed consent form, be at least 18 years old and provide valid identification;
✓. The subject is able to understand the procedures and methods of this clinical trial, has given sufficient informed consent, voluntarily participated, and signed an informed consent form by the subject themselves;
✓. On the day of enrollment, axillary temperature was ≤ 37.0 ℃;
✓. Female and male participants of childbearing age: agree to take effective contraceptive measures within 6 months after vaccination.
Exclusion criteria
✕. The laboratory test indicators specified in the protocol are abnormal and clinically significant before vaccination (only for Phase I);
✕. Have contracted influenza within the past 6 months prior to enrollment (confirmed by any clinical or microbiological method);
✕. Previously or currently suffering from autoimmune or immunodeficiency diseases;
✕. Previous history of severe allergies to any vaccine/drug or any component of the experimental vaccine, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, respiratory distress, angioneurotic edema, or individuals with an allergic constitution (such as allergies to two or more drugs, food, or pollen); History of severe allergy to eggs or egg protein;
✕. Have received any influenza vaccine within the 6 months prior to enrollment, or plan to receive influenza vaccine other than the vaccine used in this trial during the trial period (before completing the immunization and collecting blood samples);
✕. Within 30 days prior to enrollment, any investigational or unregistered products (drugs, vaccines, or devices) have been used, or are planned to be used during the trial period (except for the vaccine used in this trial) (before completing the immunization and collecting blood samples);
✕. The interval between receiving attenuated live vaccines before enrollment is less than 30 days, and the interval between receiving other non live vaccines is less than 14 days;
✕. Within the first 3 days of enrollment, have experienced acute illness or are in the acute phase of chronic illness;