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RECRUITINGPhase 3INTERVENTIONAL

Influenza Vaccination Strategy for Patients With Hematologic Malignancy

Comparison of Immunogenicity of Different Influenza Vaccines in Patients With Hematologic Malignancies

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BIOLOGICAL

High-dose trivalent inactivated influenza vaccine (HD-IIV3)

High-dose trivalent inactivated influenza vaccine containing 60 µg hemagglutinin per strain (4× standard dose). Single intramuscular injection administered during the influenza season.

BIOLOGICAL

MF59-adjuvanted quadrivalent inactivated influenza vaccine (aIIV4)

MF59C.1 squalene-based adjuvanted quadrivalent inactivated influenza vaccine containing 15 µg hemagglutinin per strain. Single intramuscular injection administered during the influenza season.

BIOLOGICAL

Standard-dose trivalent inactivated influenza vaccine (SD-IIV3)

Standard-dose trivalent inactivated influenza vaccine containing 15 µg hemagglutinin per strain. Single intramuscular injection administered during the influenza season. Active comparator.

Locations (1)

Asan Medical Center
Seoul, South Korea