Clinical Trial of Subunit Influenza Vaccine (Adjuvant) in Chinese Population Aged 65 Years and Older

NCT07421050 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: aTIV-ZHSW-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to evaluate the safety of subunit influenza vaccine (adjuvant) in people aged 65 years and older.

Conditions

Influenza; Influenza Vaccine

Outcome Measures

Primary Outcomes (5)

• Incidence of adverse events (AEs) or reactions (ARs) within 30 minutes post-vaccination

  Within 30 minutes post-vaccination

• Incidence of adverse events (AEs) or reactions (ARs) within 0-7 days post-vaccination

  Within 0-7 days post-vaccination

• Incidence of adverse events (AEs) or reactions (ARs) within 0-28 days post-vaccination

  Within 0-28 days post-vaccination

• The incidence of laboratory abnormalities (including blood biochemistry, blood routine and urine routine ) on Day 3 post-vaccination.

  On Day 3 post-vaccination

• The incidence of serious adverse events (SAEs) and Adverse Events of Special Interest (AESI) within 12 months post-vaccination.

  Within 12 months post-vaccination.

Study Arms (4)

Low-dose experimental vaccine

EXPERIMENTAL

Biological: Subunit Influenza Vaccine (Adjuvant)

High-dose experimental vaccine

EXPERIMENTAL

Biological: Subunit Influenza Vaccine (Adjuvant)

Adjuvant

OTHER

Biological: MF59

Placebo

PLACEBO COMPARATOR

Biological: 0.9% sodium chloride injection (normal saline)

Interventions

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.

Low-dose experimental vaccine

MF59 BIOLOGICAL

A single 0.5 mL dose is administered intramuscularly into the deltoid muscle of the upper arm on Day 0

Adjuvant

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.

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ab&B Bio-tech Co., Ltd.JS: lead
• Yither Biotech Co., Ltd: collaborator

Study Sites (1)

Gucheng County Center for Disease Control and Prevention

Xiangyang, Hubei, China

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Adjuvants, Pharmaceutic; MF59 oil emulsion; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions

Study Officials

• Yeqing Tong, Doctor

  Hubei Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: February 19, 2026
• Study Start: November 13, 2025
• Primary Completion (Estimated): December 13, 2026
• Study Completion (Estimated): December 13, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)