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NOT YET RECRUITING
NCT07349017
PHASE1

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

Sponsor: Changchun BCHT Biotechnology Co.

View on ClinicalTrials.gov

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

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.