drugset / Trial / NCT07349017
A Phase I Trial to Evaluate the Safety and Immunogenicity of Influenza Virus Split Vaccine (Adjuvant)
RandomizedSingle-groupDouble-blindPrevention
Summary
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.
Timeline
- Start
- 2026-02-07
- Primary completion
- 2026-04-25
- Completion
- 2027-03-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | approved influenza vaccine | Vaccine | 15 ug | — |
| Comparator | approved influenza vaccine | Vaccine | 0.5 ml | — |
| Subject | influenza vaccine（BK01 adjuvnat） | Vaccine | 15 ug | — |
| Subject | influenza vaccine（BK01 adjuvnat） | Vaccine | 0.5 ml | — |