NCT07421037Active, not recruitingPhase 1
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
Ab&B Bio-tech Co., Ltd.JS1 site in 1 country80 target enrollmentStarted: November 13, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events (AEs) or reactions (ARs) within 30 minutes post-vaccination
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •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.
Arms & Interventions
Adjuvant
Other
Intervention: MF59 (Biological)
Low-dose experimental vaccine
Experimental
Intervention: Quadrivalent Subunit Influenza Vaccine (Adjuvant) (Biological)
Placebo
Placebo Comparator
Intervention: 0.9% sodium chloride injection (normal saline) (Biological)
High-dose experimental vaccine
Experimental
Intervention: Quadrivalent Subunit Influenza Vaccine (Adjuvant) (Biological)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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