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Starting soon Phase 2

Phase Ⅱ Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above

NCT07327398 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-01-07
Last updated
2026-01-15

Condition(s) studied

Influenza

Investigational drug(s) / intervention(s)

Influenza virus split vaccine (0.7mL/vial) →Influenza virus split vaccine →

Influenza virus split vaccine (0.7mL/vial): Influenza virus split vaccine, with a specification of 0.7mL/bottle, containing 60 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each Control: Influenza virus split vaccine.

Influenza virus split vaccine: Influenza virus split vaccine, with a specification of 0.5mL/bottle, containing 15 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each.

Study summary

To evaluate the immunogenicity of administering one dose of influenza virus split vaccine (0.7mL/dose) to individuals aged 60 and above.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Age over 60 years old, gender not limited, and able to provide legal identification; * Volunteers voluntarily participate in the study and sign an informed consent form; * Volunteers have the ability to understand research procedures, use thermometers, scales, and fill out diary cards as required, and can participate in all planned follow-up visits. Exclusion Criteria: * On the day of enrollment, the axillary temperature was ≥ 37.3 ℃; * Those who have had influenza in the past 6 months or meet the definition of influenza like cases; * Have received any influenza vaccine within the past 12 months or have planned to receive any influenza vaccine during the study period; * Allergies to any components of the research vaccine, history of allergic reactions to the use of gentamicin sulfate, history of severe allergies to any vaccine/drug, or history of asthma; * Suffering from a serious illness that prevents the completion of the entire study; Within 3 days prior to vaccination, there is an acute illness or an acute exacerbation of a chronic disease; * Have used antipyretic or analgesic drugs or anti allergic drugs within 3 days before vaccination; * Have received any vaccine within 2 weeks prior to vaccination; * Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months prior to receiving the experimental vaccine, For example, immunosuppressive doses of glucocorticoids, monoclonal antibodies, thymosin, interferon, etc., or planned to receive such treatment within one month after the first dose of vaccination to full immunization, but local medication is allowed; * Suffering from congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, or other autoimmune diseases; * Suffering from serious chronic diseases, serious cardiovascular diseases, such as hypertension that cannot be controlled by drugs, diabetes that cannot be controlled by drugs or has serious complications, liver and kidney diseases, pulmonary edema, malignant tumors, etc; * Have received blood or blood related products within the past 6 months; * Individuals with progressive neurological disorders, including a history of seizures, epilepsy, encephalopathy, Guillain Barr é syndrome, psychiatric or family history; * Have a history of abnormal coagulation function and have been using anticoagulants within 3 weeks before vaccination; * Patients with splenectomy, functional splenectomy, splenectomy, or other important organ resection or partial resection; * Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit; * Currently or recently planning to participate in other clinical trials; * Researchers determine any situation that is not suitable for clinical trials.

Primary outcome measure(s)

  • Seroconversion rate — 30 days after vaccination
    30 days after vaccination of all participants with the experimental vaccine or control vaccines, the HI antibody seroconversion rate against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
  • Ratio of ≥1:40 — 30 days after vaccination
    30 days after vaccination of all participants with the experimental vaccine or control vaccines, the ratio of HI antibody titers ≥ 1:40 against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
  • Geometric mean titer (GMT) — 30 days after vaccination
    30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMT of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
  • Geometric mean increase (GMI) — 30 days after vaccination
    30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMI of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.

Trial sites (2)

FacilityCityRegionStatus
Danjiangkou City Center for Disease Control and Prevention Wuhan Hubei
Yunxi County Center for Disease Control and Prevention Wuhan Hubei
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07327398 on ClinicalTrials.gov ↗ ← All trials in China