Clinical Trials of Quadrivalent Influenza Vaccine
- Summary
- 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.
- Short title
- Clinical Trials of Quadrivalent Influenza Vaccine
- Official title
- A Randomized, Blinded Phase I./II Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2026-09-01
- First posted
- 2025-02-13
- Registry last updated
- 2026-05-05
- Primary completion date
- 2025-08-05
- Start date
- 2025-05-08
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Randomisation ratio
- 2:2:1
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06824519
- ClinicalTrials.gov ID
- NCT06824519
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Triple masking
- Masked roles
- Participants, Care providers, Investigators
AE occurren
Timeframe: within 30 days after vaccination
Number and incidence of all adverse events
AESI occurrences
Timeframe: within 30 days after vaccination
Number and incidence of all adverse events of special interest
SAE occurrences
Timeframe: within 12 months after vaccination
Number and incidence of all serious adverse events
Serum alanine aminotransferase level
Timeframe: on the 4th day after vaccination
All participants in Phase I were tested for alanine aminotransferase levels before and on the 4th day after vaccination
Serum aspartate transaminase level
Timeframe: on the 4th day after vaccination
All participants in Phase I were tested for aspartate transaminase levels before and on the 4th day after vaccination
Serum total bilirubin level
Timeframe: on the 4th day after vaccination
All participants in Phase I were tested for total bilirubin levels before and on the 4th day after vaccination
Serum white blood cell level
Timeframe: on the 4th day after vaccination
All participants in Phase I were tested for white blood cell levels before and on the 4th day after vaccination
Serum platelet level
Timeframe: on the 4th day after vaccination
All participants in Phase I were tested for platelet levels before and on the 4th day after vaccination
Serum hemoglobin level
Timeframe: on the 4th day after vaccination
All participants in Phase I were tested for hemoglobin levels before and on the 4th day after vaccination
Urinary protein level in urine
Timeframe: on the 4th day after vaccination
All participants in Phase I were tested for urinary protein levels in urine before and on the 4th day after vaccination
Urinary red blood cell level in urine
Timeframe: on the 4th day after vaccination
All participants in Phase I were tested for urinary red blood cell levels in urine before and on the 4th day after vaccination
Serum antibody level
Timeframe: 30 days after vaccination
Detect the levels of hemagglutination inhibition (HI) antibodies against influenza viruses H1N1, H3N2, and type B (B/Victoria and B/Yamagata).
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- Yes
- When signing the informed consent form, be at least 18 years old and provide valid identification;
- The subject is able to understand the procedures and methods of this clinical trial, has given sufficient informed consent, voluntarily participated, and signed an informed consent form by the subject themselves;
- On the day of enrollment, axillary temperature was ≤ 37.0 ℃;
- Female and male participants of childbearing age: agree to take effective contraceptive measures within 6 months after vaccination.
- The laboratory test indicators specified in the protocol are abnormal and clinically significant before vaccination (only for Phase I);
- Have contracted influenza within the past 6 months prior to enrollment (confirmed by any clinical or microbiological method);
- Previously or currently suffering from autoimmune or immunodeficiency diseases;
- Previous history of severe allergies to any vaccine/drug or any component of the experimental vaccine, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, respiratory distress, angioneurotic edema, or individuals with an allergic constitution (such as allergies to two or more drugs, food, or pollen); History of severe allergy to eggs or egg protein;
- Have received any influenza vaccine within the 6 months prior to enrollment, or plan to receive influenza vaccine other than the vaccine used in this trial during the trial period (before completing the immunization and collecting blood samples);
- Within 30 days prior to enrollment, any investigational or unregistered products (drugs, vaccines, or devices) have been used, or are planned to be used during the trial period (except for the vaccine used in this trial) (before completing the immunization and collecting blood samples);
- The interval between receiving attenuated live vaccines before enrollment is less than 30 days, and the interval between receiving other non live vaccines is less than 14 days;
- Within the first 3 days of enrollment, have experienced acute illness or are in the acute phase of chronic illness;
- Used antipyretic, analgesic, or anti allergic drugs within 3 days prior to enrollment;
- Use immunoglobulin and/or any blood products within 3 months prior to enrollment, or plan to use them during the trial period (before completing immunization and collecting blood samples);
- Long term use of immunosuppressants or other immunomodulatory drugs (defined as continuous use for more than 14 days) within the first 3 months of enrollment, such as a glucocorticoid dose of ≥ 0.5 mg/kg/day (inhalation and local steroid hormones are not restricted);
- Absence of spleen, functional absence of spleen, and splenectomy caused by any condition;
- Any obvious coagulation dysfunction or history of anticoagulant therapy;
- History of epilepsy, encephalopathy, and malignant tumors;
- Suffering from serious cardiovascular system diseases, serious hypertension with unstable drugs (systolic pressure ≥ 160mmHg and/or diastolic pressure ≥ 100mmHg), diabetes with serious complications and other serious chronic diseases;
- Currently suffering from respiratory system diseases (including pneumonia, tuberculosis, severe asthma, chronic bronchitis, etc.), acute liver and kidney diseases (severe impairment of liver and kidney function), mental disorders (such as schizophrenia, depression, affective disorders, etc.), etc;
- Women of childbearing age who are breastfeeding, pregnant, or have a positive urine pregnancy test before enrollment;
- Plan to move out of the local area before the end of the study or plan to leave the local area for a long time during the study visit;
- According to the researchers' judgment, the subjects have any other factors that are not suitable for participating in the clinical trial.
- Hebei Province Centers for Disease Control and PreventionShijiazhuang, ChinaRecruiting
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Influenza Primary condition