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A Phase I Trial to Evaluate the Safety and Immunogenicity of Influenza Virus Split Vaccine (Adjuvant)
Sponsor: Changchun BCHT Biotechnology Co.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2026-02-07
Completion Date
2027-03-07
Last Updated
2026-01-16
Healthy Volunteers
Yes
Conditions
Interventions
influenza vaccine(BK01 adjuvnat)
Each human dose is 0.5 mL, containing 15 μg of hemagglutinin from each type of influenza virus strain.
approved influenza vaccine
Each human dose is 0.5 mL, containing 15 μg of hemagglutinin from each type of influenza virus strain.
adjuvant placebo
Each human dose is 0.5 mL, containing no influenza virus strain hemagglutinin. The main ingredient is BK-01 adjuvant.
placebo
Each human dose is 0.5 mL. The main ingredient is sodium chloride.