NCT07349017

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

A Single-Center, Randomized, Blinded Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Influenza Virus Vaccine (BK-01 Adjuvant) in Populations Aged 18 Years and Older

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Changchun BCHT Biotechnology Co. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	influenza vaccine（BK01 adjuvnat）	Each human dose is 0.5 mL, containing 15 μg of hemagglutinin from each type of influenza virus strain.
BIOLOGICAL	approved influenza vaccine	Each human dose is 0.5 mL, containing 15 μg of hemagglutinin from each type of influenza virus strain.
BIOLOGICAL	adjuvant placebo	Each human dose is 0.5 mL, containing no influenza virus strain hemagglutinin. The main ingredient is BK-01 adjuvant.
BIOLOGICAL	placebo	Each human dose is 0.5 mL. The main ingredient is sodium chloride.

Timeline

• Start date: 2026-02-07
• Primary completion: 2026-04-25
• Completion: 2027-03-07
• First posted: 2026-01-16
• Last updated: 2026-01-16