Influenza, HumanPhase 1/2NCT06824519
Clinical Trials of Quadrivalent Influenza Vaccine
A Phase 1/2 study testing Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose), Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose) and Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in people with Influenza, Human, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose), Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose) and Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 620 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2025to Sep 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hebei Province Centers for Disease Control and Prevention
Shijiazhuang, Hebei
Fei Jin, 13722795742, ycjf3000@126.com
About this study
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
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.
Read the detailed description
Overall design:
Adopting a randomized, blinded research design. This experiment adopts a seamless connection design of Phase I/II, conducted in two stages: Phase I and Phase II. Phase I is the age/dose escalation stage, and Phase II is the dose extension stage.
Age/dose escalation stage: A randomized, blinded, placebo-controlled study design was used. 120 subjects were enrolled in the study, in order of age from 18 to 49 years old to 50 years old and above, from low dose to high dose. They were divided into four cohorts, with 30 subjects in each cohort (including 20 who received high-dose or low-dose experimental vaccines and 10 who received placebo). The first 6 subjects in each cohort were assigned to be sentinel group, and the researchers reviewed the safety data of the sentinel group within 7 days after vaccination. After confirming safety (not meeting the criteria for suspending/terminating the trial), the remaining 24 subjects in the cohort were enrolled.
Dose expansion stage: A randomized, blinded, positive controlled study design was used. 500 subjects were enrolled, divided into two age groups: 18-49 years old and 50 years old and above. 250 subjects were enrolled in each age group and randomly divided into low-dose group, high-dose group, and positive control group according to a 2:2:1 ratio. The proportion of people aged 60 and above in the population aged 50 and above shall not be less than 80%, and the proportion of people aged 70 and above shall not be less than 30%.
- Conditions
- Influenza, Human
- Being tested
- Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose), Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (low dose), Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose), Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (high dose), Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose)Biological
Inject 1 dose of low-dose vaccine
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (low dose)Biological
Inject 1 dose of low-dose placebo
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose)Biological
Inject 1 dose of high-dose vaccine
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (high dose)Biological
Inject 1 dose of high-dose placebo
Influenza Vaccine (Split Virion), Inactivated, QuadrivalentBiological
Inject 1 dose of positive control vaccine
| Study group | Role | What they receive |
|---|---|---|
| Phase I cohort 1 low-dose group | Experimental | 20 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. Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose) |
| Phase I cohort 1 low-dose placebo group | Placebo comparator | 10 subjects aged 18-49 were enrolled and randomly assigned to the low-dose placebo group, and received one dose of the low-dose placebo. Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (low dose) |
| Phase I cohort 2 high-dose group | Experimental | 20 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. Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose) |
| Phase I cohort 2 high-dose placebo group | Placebo comparator | 10 subjects aged 18-49 were enrolled and randomly assigned to the high-dose placebo group, and received one dose of the high-dose placebo. Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (high dose) |
| Phase I cohort 3 low-dose group | Experimental | 20 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. Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose) |
| Phase I cohort 3 low-dose placebo group | Placebo comparator | 10 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. Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (low dose) |
| Phase I cohort 4 high-dose group | Experimental | 20 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. Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose) |
| Phase I cohort 4 high-dose placebo group | Placebo comparator | 10 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. Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (high dose) |
| Phase II low-dose group (18-49 years old) | Experimental | 100 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. Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose) |
| Phase II high-dose group (18-49 years old) | Experimental | 100 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. Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose) |
| Phase II positive control group (18-49 years old) | Active comparator | 50 subjects aged 18-49 were enrolled and randomly assigned to the positive control group, and received one dose of the positive control vaccine. Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent |
| Phase II low-dose group (50 years old and above) | Experimental | 100 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. Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose) |
| Phase II high-dose group (50 years old and above) | Experimental | 100 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. Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose) |
| Phase II positive control group (50 years old and above) | Active comparator | 50 subjects aged 50 and above were enrolled and randomly assigned to the positive control group, and received one dose of the positive control vaccine. Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE occurren
Number and incidence of all adverse events
Measured: within 30 days after vaccination
AESI occurrences
Number and incidence of all adverse events of special interest
Measured: within 30 days after vaccination
SAE occurrences
Number and incidence of all serious adverse events
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 30 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start8 May 2025
- Primary completion5 Aug 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fei Jin, Principal investigator, Hebei Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824519
- Sponsor's protocol ID
- LKM-2024-FIn-001
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06824519
- Acronym / sponsor ID
- LKM-2024-FIn-001
- Conditions
- Influenza, Human
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 May 2025 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Overall design:
Adopting a randomized, blinded research design. This experiment adopts a seamless connection design of Phase I/II, conducted in two stages: Phase I and Phase II. Phase I is the age/dose escalation stage, and Phase II is the dose extension stage.
Age/dose escalation stage: A randomized, blinded, placebo-controlled study design was used. 120 subjects were enrolled in the study, in order of age from 18 to 49 years old to 50 years old and above, from low dose to high dose. They were divided into four cohorts, with 30 subjects in each cohort (including 20 who received high-dose or low-dose experimental vaccines and 10 who received placebo). The first 6 subjects in each cohort were assigned to be sentinel group, and the researchers reviewed the safety data of the sentinel group within 7 days after vaccination. After confirming safety (not meeting the criteria for suspending/terminating the trial), the remaining 24 subjects in the cohort were enrolled.
Dose expansion stage: A randomized, blinded, positive controlled study design was used. 500 subjects were enrolled, divided into two age groups: 18-49 years old and 50 years old and above. 250 subjects were enrolled in each age group and randomly divided into low-dose group, high-dose group, and positive control group according to a 2:2:1 ratio. The proportion of people aged 60 and above in the population aged 50 and above shall not be less than 80%, and the proportion of people aged 70 and above shall not be less than 30%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Phase I cohort 1 low-dose group | Experimental | Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose)20 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 comparator | Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (low dose)10 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 | Experimental | Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose)20 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 comparator | Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (high dose)10 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 | Experimental | Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose)20 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 comparator | Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (low dose)10 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 | Experimental | Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose)20 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 comparator | Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (high dose)10 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) | Experimental | Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose)100 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) | Experimental | Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose)100 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 comparator | Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent50 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) | Experimental | Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose)100 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) | Experimental | Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose)100 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 comparator | Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent50 subjects aged 50 and above were enrolled and randomly assigned to the positive control group, and received one dose of the positive control vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose)Inject 1 dose of low-dose vaccine | Biological | Phase I cohort 1 low-dose group, Phase I cohort 3 low-dose group, Phase II low-dose group (18-49 years old), Phase II low-dose group (50 years old and above) |
| Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (low dose)Inject 1 dose of low-dose placebo | Biological | Phase I cohort 1 low-dose placebo group, Phase I cohort 3 low-dose placebo group |
| Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose)Inject 1 dose of high-dose vaccine | Biological | Phase I cohort 2 high-dose group, Phase I cohort 4 high-dose group, Phase II high-dose group (18-49 years old), Phase II high-dose group (50 years old and above) |
| Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (high dose)Inject 1 dose of high-dose placebo | Biological | Phase I cohort 2 high-dose placebo group, Phase I cohort 4 high-dose placebo group |
| Influenza Vaccine (Split Virion), Inactivated, QuadrivalentInject 1 dose of positive control vaccine | Biological | Phase II positive control group (18-49 years old), Phase II positive control group (50 years old and above) |
Primary outcome
AE occurren
Time frame: within 30 days after vaccination
Number and incidence of all adverse events
AESI occurrences
Time frame: within 30 days after vaccination
Number and incidence of all adverse events of special interest
SAE occurrences
Time frame: within 12 months after vaccination
Number and incidence of all serious adverse events
Serum alanine aminotransferase level
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fei Jin principal investigator
Hebei Province Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose), Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose) and Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in people with Influenza, Human, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fei Jin (13722795742, ycjf3000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE occurren (time frame: within 30 days after vaccination). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.