Clinical Trials of Quadrivalent Influenza Vaccine
A Randomized, Blinded Phase I./II Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant
1 other identifier
interventional
620
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2025
CompletedFirst Posted
Study publicly available on registry
February 13, 2025
CompletedStudy Start
First participant enrolled
May 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedMay 5, 2026
April 1, 2026
3 months
January 22, 2025
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (12)
AE occurren
Number and incidence of all adverse events
within 30 days after vaccination
AESI occurrences
Number and incidence of all adverse events of special interest
within 30 days after vaccination
SAE occurrences
Number and incidence of all serious adverse events
within 12 months after vaccination
Serum alanine aminotransferase level
All participants in Phase I were tested for alanine aminotransferase levels before and on the 4th day after vaccination
on the 4th day after vaccination
Serum aspartate transaminase level
All participants in Phase I were tested for aspartate transaminase levels before and on the 4th day after vaccination
on the 4th day after vaccination
Serum total bilirubin level
All participants in Phase I were tested for total bilirubin levels before and on the 4th day after vaccination
on the 4th day after vaccination
Serum white blood cell level
All participants in Phase I were tested for white blood cell levels before and on the 4th day after vaccination
on the 4th day after vaccination
Serum platelet level
All participants in Phase I were tested for platelet levels before and on the 4th day after vaccination
on the 4th day after vaccination
Serum hemoglobin level
All participants in Phase I were tested for hemoglobin levels before and on the 4th day after vaccination
on the 4th day after vaccination
Urinary protein level in urine
All participants in Phase I were tested for urinary protein levels in urine before and on the 4th day after vaccination
on the 4th day after vaccination
Urinary red blood cell level in urine
All participants in Phase I were tested for urinary red blood cell levels in urine before and on the 4th day after vaccination
on the 4th day after vaccination
Serum antibody level
Detect the levels of hemagglutination inhibition (HI) antibodies against influenza viruses H1N1, H3N2, and type B (B/Victoria and B/Yamagata).
30 days after vaccination
Study Arms (14)
Phase I cohort 1 low-dose group
EXPERIMENTAL20 subjects aged 18-49 were enrolled and randomly assigned to the low-dose experimental group, and received one dose of the low-dose experimental vaccine.
Phase I cohort 1 low-dose placebo group
PLACEBO COMPARATOR10 subjects aged 18-49 were enrolled and randomly assigned to the low-dose placebo group, and received one dose of the low-dose placebo.
Phase I cohort 2 high-dose group
EXPERIMENTAL20 subjects aged 18-49 were enrolled and randomly assigned to the high-dose experimental group, and received one dose of the high-dose experimental vaccine.
Phase I cohort 2 high-dose placebo group
PLACEBO COMPARATOR10 subjects aged 18-49 were enrolled and randomly assigned to the high-dose placebo group, and received one dose of the high-dose placebo.
Phase I cohort 3 low-dose group
EXPERIMENTAL20 subjects aged 50 and above were enrolled and randomly assigned to the low-dose experimental group, and received one dose of the low-dose experimental vaccine.
Phase I cohort 3 low-dose placebo group
PLACEBO COMPARATOR10 subjects aged 50 and above were enrolled and randomly assigned to the low-dose placebo group, and received one dose of the low-dose placebo.
Phase I cohort 4 high-dose group
EXPERIMENTAL20 subjects aged 50 and above were enrolled and randomly assigned to the high-dose experimental group, and received one dose of the high-dose experimental vaccine.
Phase I cohort 4 high-dose placebo group
PLACEBO COMPARATOR10 subjects aged 50 and above were enrolled and randomly assigned to the high-dose placebo group, and received one dose of the high-dose placebo.
Phase II low-dose group (18-49 years old)
EXPERIMENTAL100 subjects aged 18-49 were enrolled and randomly assigned to the low-dose experimental group, and received one dose of the low-dose experimental vaccine.
Phase II high-dose group (18-49 years old)
EXPERIMENTAL100 subjects aged 18-49 were enrolled and randomly assigned to the high-dose experimental group, and received one dose of the high-dose experimental vaccine.
Phase II positive control group (18-49 years old)
ACTIVE COMPARATOR50 subjects aged 18-49 were enrolled and randomly assigned to the positive control group, and received one dose of the positive control vaccine.
Phase II low-dose group (50 years old and above)
EXPERIMENTAL100 subjects aged 50 and above were enrolled and randomly assigned to the low-dose experimental group, and received one dose of the low-dose experimental vaccine.
Phase II high-dose group (50 years old and above)
EXPERIMENTAL100 subjects aged 50 and above were enrolled and randomly assigned to the high-dose experimental group, and received one dose of the high-dose experimental vaccine.
Phase II positive control group (50 years old and above)
ACTIVE COMPARATOR50 subjects aged 50 and above were enrolled and randomly assigned to the positive control group, and received one dose of the positive control vaccine.
Interventions
Inject 1 dose of low-dose vaccine
Inject 1 dose of low-dose placebo
Inject 1 dose of high-dose vaccine
Inject 1 dose of high-dose placebo
Inject 1 dose of positive control vaccine
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hebei Province Centers for Disease Control and Prevention
Shijiazhuang, Hebei, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fei Jin
Hebei Province Centers for Disease Control and Prevention
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2025
First Posted
February 13, 2025
Study Start
May 8, 2025
Primary Completion
August 5, 2025
Study Completion (Estimated)
September 1, 2026
Last Updated
May 5, 2026
Record last verified: 2026-04