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Recruiting Phase 3 NCT07485855

Influenza Vaccination Strategy for Patients With Hematologic Malignancy

Trial Parameters

Condition Hematologic Neoplasms
Sponsor Asan Medical Center
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 60
Sex ALL
Min Age 19 Years
Max Age N/A
Start Date 2025-12-04
Completion 2027-04-30
Interventions
High-dose trivalent inactivated influenza vaccine (HD-IIV3)MF59-adjuvanted quadrivalent inactivated influenza vaccine (aIIV4)Standard-dose trivalent inactivated influenza vaccine (SD-IIV3)

Brief Summary

This randomized controlled trial evaluates and compares the immunogenicity of three different influenza vaccine formulations: high-dose trivalent (HD-IIV3), MF59-adjuvanted quadrivalent (aIIV4), and standard-dose trivalent (SD-IIV3) vaccines. The study population consists of patients with hematologic malignancies, including those undergoing autologous stem cell transplantation or CAR-T cell therapy. The primary goal is to identify which vaccine strategy elicits the most robust antibody and T cell-mediated immune responses in this severely immunocompromised population

Eligibility Criteria

Inclusion Criteria: * Adults aged 19 years or older * Confirmed diagnosis of hematologic malignancy, including: non-Hodgkin lymphoma, Hodgkin lymphoma, acute leukemia, chronic leukemia, or plasma cell disorders Exclusion Criteria: * Difficulty with repeated venipuncture or blood sampling (e.g., poor vascular access or bleeding tendency) * Cognitive or psychiatric impairment precluding understanding of or cooperation with study procedures * Known hypersensitivity to influenza vaccine components * Influenza vaccination within the preceding 6 months * Any other condition deemed clinically inappropriate for study participation at investigator discretion

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