Clinical Trial

A Phase I Trial to Evaluate the Safety and Immunogenicity of Influenza Virus Split Vaccine (Adjuvant)

Not Yet Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated January 16, 2026 (before its estimated April 25, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07349017
Lead Sponsor Changchun BCHT Biotechnology Co.
Conditions Influenza
Enrollment 160 participants
Start Date 2026-02-07
Primary Completion 2026-04-25 (estimated)
Study Completion 2027-03-07 (estimated)
Updated on ClinicalTrials.gov 2026-01-16