MedTrace Logo

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

NCT07349017 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-01-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Changchun BCHT Biotechnology Co.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-07
Primary Completion
2026-04-25
Completion
2027-03-07

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07349017 on ClinicalTrials.gov