The goal of this clinical trial is to evaluate the safety and immunogenicity of the influenza virus vaccine (BK-01 adjuvant) in people aged 18 years and older.
The main questions it aims to answer is:
• Incidence rate of adverse reactions/events after administration Participants will be randomly vaccinated with a single dose of the trial vaccine, control vaccine, adjuvant placebo, or placebo in a 1:1:1:1 ratio. After vaccination, all participants will undergo up to 30-day observation and blood collection.
Participants aged 18 years and above;
Have not received any influenza vaccine in the past six months and have no plan to receive other influenza vaccines during the trial period;
Have not had influenza in the past 6 months (confirmed by any clinical, serological, or microbiological method);
Able to obtain the participant's own informed consent;
Axillary temperature > 37.0℃ on the day of enrollment;
Female participants of childbearing age with a positive urine pregnancy test result, or who are breastfeeding, or have a plan to have children within 12 months;
Those with a history of severe allergic diseases (such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reaction), or who are allergic to any component of the test vaccine, such as eggs, gentamicin sulfate, formaldehyde, TritonX-100, etc.;
Those with clinically significant abnormal laboratory test results, which are determined by the researcher as unsuitable for vaccine vaccination；