Actively Recruiting
Clinical Trials of Quadrivalent Influenza Vaccine
Led by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Updated on 2026-05-05
620
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial adopts a seamless design of phase I/II, conducted in two stages: phase I and phase II. Phase I is the age/dose ramp up stage, and phase II is the dose expansion stage.The purpose of this clinical trial is to evaluate the safety and tolerability of different doses of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant，explore the immunogenicity of the vaccine, and determine the appropriate dose for later clinical trials of this product.
CONDITIONS
Official Title
Clinical Trials of Quadrivalent Influenza Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years old and provide valid identification when signing consent
- Understand the study procedures and voluntarily agree to participate by signing informed consent
- Have an axillary temperature of 37.0°C or lower on enrollment day
- Agree to use effective contraception for 6 months after vaccination if of childbearing potential
You will not qualify if you...
- Have abnormal and clinically significant lab test results before vaccination (Phase I only)
- Had influenza within 6 months before enrollment
- Have autoimmune or immunodeficiency diseases
- History of severe allergies to vaccines, drugs, egg proteins, or allergic conditions like anaphylactic shock or respiratory distress
- Received any influenza vaccine within 6 months prior or plan to receive another influenza vaccine during the trial
- Used investigational or unregistered products within 30 days before enrollment or plan to during the trial (except this vaccine)
- Received live attenuated vaccines less than 30 days or other vaccines less than 14 days before enrollment
- Have acute illness or are in an acute phase of chronic illness within 3 days before enrollment
- Used antipyretic, analgesic, or anti-allergic drugs within 3 days prior to enrollment
- Used immunoglobulin or blood products within 3 months before enrollment or plan to during the trial
- Long-term use of immunosuppressants or immunomodulatory drugs within 3 months before enrollment
- Absence or functional absence of spleen
- Have coagulation problems or history of anticoagulant therapy
- History of epilepsy, encephalopathy, or malignant tumors
- Serious cardiovascular diseases, uncontrolled hypertension, diabetes with serious complications, or other serious chronic diseases
- Current respiratory diseases like pneumonia or severe asthma, acute liver/kidney diseases, or mental disorders
- Pregnant, breastfeeding, or positive pregnancy test before enrollment
- Plan to move away or be unavailable during the study
- Any other condition judged by researchers to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hebei Province Centers for Disease Control and Prevention
Shijiazhuang, Hebei, China
Actively Recruiting
Research Team
F
Fei Jin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
14
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