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Influenza Vaccination Strategy for Patients With Hematologic Malignancy
Sponsor: Asan Medical Center
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
Official title: Comparison of Immunogenicity of Different Influenza Vaccines in Patients With Hematologic Malignancies
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-12-04
Completion Date
2028-04-30
Last Updated
2026-03-24
Healthy Volunteers
No
Interventions
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.
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.
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