InfluenzaPhase 1NCT07421037
Clinical Trial of Quadrivalent Subunit Influenza Vaccine (Adjuvant) in Chinese Population Aged 65 Years and Older
A Phase 1 study testing Quadrivalent Subunit Influenza Vaccine (Adjuvant), MF59 and 0.9% sodium chloride injection (normal saline) in people with Influenza and Influenza Vaccine, run by Ab&B Bio-tech Co., Ltd.JS at 1 site in China.
Trial summary
The objective of this study was to evaluate the safety of quadrivalent subunit influenza vaccine (adjuvant) in people aged 65 years and older. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Influenza Vaccine
- What is being tested?
- Quadrivalent Subunit Influenza Vaccine (Adjuvant), MF59 and 0.9% sodium chloride injection (normal saline)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2025to 13 Dec 2026
- Phase
- Phase 1
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age at enrollment is ≥65 years (including the 65th birthday).
- The participant voluntarily agrees to take part in the trial and has signed the informed consent form.
- The participant is able to comply with the trial follow-up schedule as required by the protocol (i.e., no plans for long-term absence or relocation from the study site).
- Medically stable: The participant may have underlying chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but symptoms/signs must be controlled. If the participant is on any medication, the dosage must have remained stable for at least three weeks prior to vaccination.
Who cannot join
- Axillary temperature >37.0°C.
- Confirmed influenza virus infection by laboratory test or self-test kit positive within the past 12 months.
- Received any influenza vaccine (licensed or investigational) within the past 12 months or plans to receive any influenza vaccine during the study.
- Known or suspected allergic to any component of the investigational vaccine.
- A history of severe allergic reactions to any vaccines or medications (for example, but not limited to: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reaction (Arthus reaction)).
- Congenital malformations or developmental disorders, and genetic defects or severe malnutrition.
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- History of convulsions or seizures, epilepsy, psychiatric disorders, or relevant family history.
- Severe liver and kidney diseases, malignant tumors, various acute diseases, or being in the acute exacerbation stage of a chronic disease.
- Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other immune-mediated/autoimmune diseases.
- A history of asthma, unstable within the past two years requiring emergency treatment, hospitalization, intubation, or oral/intravenous corticosteroids.
- Individuals who have received immunostimulant or immunosuppressant therapy within the past 6 months (continuously administered orally or via drip infusion for more than 14 days).
- Suffering from severe cardiovascular diseases (e.g., heart disease, cor pulmonale, pulmonary edema).
- Blood pressure ≥150/100 mmHg despite medication control.
- History of live attenuated vaccine within 28 days prior to vaccination, or any other vaccine within 14 days prior to vaccination.
- Diagnosed with progressive neurological diseases, or a history of Guillain-Barré syndrome.
- Asplenia or functional asplenia, including splenectomy due to any reason, or resection/partial removal of other vital organs.
- Received blood or blood-derived products within the past 6 months.
- A diagnosed history of coagulation disorders (e.g., coagulation factor deficiencies, coagulopathies, platelet disorders).
- Currently undergoing anti-tuberculosis treatment.
- Clinically significant abnormalities in laboratory tests (blood biochemistry, blood routine and urine routine) as determined by the investigator.
- Any condition that, in the opinion of the investigator, makes the participant unsuitable for this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Yunxi County Center for Disease Control and Prevention
Shiyan, Hubei
About this study
Official title: A Randomized, Blinded, Controlled Phase I Clinical Trial to Evaluate the Safety of a Quadrivalent Subunit Influenza Vaccine (Adjuvant) in Adults Aged 65 Years and Older
The objective of this study was to evaluate the safety of quadrivalent subunit influenza vaccine (adjuvant) in people aged 65 years and older.
- Conditions
- Influenza, Influenza Vaccine
- Being tested
- Quadrivalent Subunit Influenza Vaccine (Adjuvant), MF59, 0.9% sodium chloride injection (normal saline)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent Subunit Influenza Vaccine (Adjuvant)Biological
A single 0.25 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0.
Quadrivalent Subunit Influenza Vaccine (Adjuvant)Biological
A single 0.5 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0.
MF59Biological
A single 0.5 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0
0.9% sodium chloride injection (normal saline)Biological
A single 0.5 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose experimental vaccine | Experimental | Not described Receives: Biological: Quadrivalent Subunit Influenza Vaccine (Adjuvant) |
| High-dose experimental vaccine | Experimental | Not described Receives: Biological: Quadrivalent Subunit Influenza Vaccine (Adjuvant) |
| Adjuvant | Other | Not described Receives: Biological: MF59 |
| Placebo | Placebo comparator | Not described Receives: Biological: 0.9% sodium chloride injection (normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) or reactions (ARs) within 30 minutes post-vaccination
Measured: Within 30 minutes post-vaccination
Incidence of adverse events (AEs) or reactions (ARs) within 0-7 days post-vaccination
Measured: Within 0-7 days post-vaccination
Incidence of adverse events (AEs) or reactions (ARs) within 0-28 days post-vaccination
Measured: Within 0-28 days post-vaccination
The incidence of laboratory abnormalities (including blood biochemistry, blood routine and urine routine ) on Day 3 post-vaccination.
Measured: On Day 3 post-vaccination
The incidence of serious adverse events (SAEs) and Adverse Events of Special Interest (AESI) within 12 months post-vaccination.
Measured: Within 12 months post-vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start13 Nov 2025
- Primary completion13 Dec 2026 (estimated)
- Study completion13 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JS
- Sponsor type
- University, hospital or other
- Collaborators
- Yither Biotech Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Yeqing Tong, Doctor, Principal investigator, Hubei Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421037
- Sponsor's protocol ID
- aQIV-ZHSW-01
- Status last verified
- Feb 2026
- First submitted
- 13 Nov 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Controlled Phase I Clinical Trial to Evaluate the Safety of a Quadrivalent Subunit Influenza Vaccine (Adjuvant) in Adults Aged 65 Years and Older
- ClinicalTrials.gov ID
- NCT07421037
- Acronym / sponsor ID
- aQIV-ZHSW-01
- Conditions
- Influenza, Influenza Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JSUniversity, hospital or other
- Collaborators
- Yither Biotech Co., Ltd
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 13 Dec 2026 (estimated)
- Study completion
- 13 Dec 2026 (estimated)
- First posted
- 19 Feb 2026 (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.
The objective of this study was to evaluate the safety of quadrivalent subunit influenza vaccine (adjuvant) in people aged 65 years and older.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-dose experimental vaccine | Experimental | Biological: Quadrivalent Subunit Influenza Vaccine (Adjuvant) |
| High-dose experimental vaccine | Experimental | Biological: Quadrivalent Subunit Influenza Vaccine (Adjuvant) |
| Adjuvant | Other | Biological: MF59 |
| Placebo | Placebo comparator | Biological: 0.9% sodium chloride injection (normal saline) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age at enrollment is ≥65 years (including the 65th birthday).
- The participant voluntarily agrees to take part in the trial and has signed the informed consent form.
- The participant is able to comply with the trial follow-up schedule as required by the protocol (i.e., no plans for long-term absence or relocation from the study site).
- Medically stable: The participant may have underlying chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but symptoms/signs must be controlled. If the participant is on any medication, the dosage must have remained stable for at least three weeks prior to vaccination.
Key exclusion criteria (21 listed)
- Axillary temperature >37.0°C.
- Confirmed influenza virus infection by laboratory test or self-test kit positive within the past 12 months.
- Received any influenza vaccine (licensed or investigational) within the past 12 months or plans to receive any influenza vaccine during the study.
- Known or suspected allergic to any component of the investigational vaccine.
- A history of severe allergic reactions to any vaccines or medications (for example, but not limited to: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reaction (Arthus reaction)).
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 |
|---|---|---|
| Quadrivalent Subunit Influenza Vaccine (Adjuvant)A single 0.25 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0. | Biological | Low-dose experimental vaccine |
| Quadrivalent Subunit Influenza Vaccine (Adjuvant)A single 0.5 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0. | Biological | High-dose experimental vaccine |
| MF59A single 0.5 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0 | Biological | Adjuvant |
| 0.9% sodium chloride injection (normal saline)A single 0.5 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0. | Biological | Placebo |
Primary outcome
Incidence of adverse events (AEs) or reactions (ARs) within 30 minutes post-vaccination
Time frame: Within 30 minutes post-vaccination
Incidence of adverse events (AEs) or reactions (ARs) within 0-7 days post-vaccination
Time frame: Within 0-7 days post-vaccination
Incidence of adverse events (AEs) or reactions (ARs) within 0-28 days post-vaccination
Time frame: Within 0-28 days post-vaccination
The incidence of laboratory abnormalities (including blood biochemistry, blood routine and urine routine ) on Day 3 post-vaccination.
Time frame: On Day 3 post-vaccination
The incidence of serious adverse events (SAEs) and Adverse Events of Special Interest (AESI) within 12 months post-vaccination.
Time frame: Within 12 months post-vaccination.
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 19 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yeqing Tong, Doctor principal investigator
Hubei Provincial Center 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 study testing Quadrivalent Subunit Influenza Vaccine (Adjuvant), MF59 and 0.9% sodium chloride injection (normal saline) in people with Influenza and Influenza Vaccine, run by Ab&B Bio-tech Co., Ltd.JS 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 21 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: under way, not looking for participants, as of the sponsor's last update on 19 Feb 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 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) or reactions (ARs) within 30 minutes post-vaccination (time frame: Within 30 minutes post-vaccination). The study lists 5 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 19 Feb 2026.