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

Sponsor
Changchun BCHT Biotechnology Co.
Study ID
NCT07349017
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jan 16, 2026
Start date
Feb 7, 2026
Status verified
Jan 2026
Primary completion
Apr 25, 2026
Completion
Mar 7, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: influenza vaccine（BK01 adjuvant）
  • Active Comparator: approved influenza vaccine
  • Placebo Comparator: adjuvant placebo
  • Placebo Comparator: placebo

Primary Outcome Measure

Safety outcome [ Time Frame: upto 30 days after vaccination ]

Central Contacts

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