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Clinical Trials in South Korea / NCT07485855
Recruiting Phase 3

Influenza Vaccination Strategy for Patients With Hematologic Malignancy

NCT07485855 · tracked via the Priya Life Science South Korea tracker
Sponsor
Asan Medical Center
Phase
Phase 3
Started
2025-12-04
Last updated
2026-09-01

Condition(s) studied

Hematologic NeoplasmsInfluenzaImmunogenicity

Investigational drug(s) / intervention(s)

High-dose trivalent inactivated influenza vaccine (HD-IIV3)MF59-adjuvanted quadrivalent inactivated influenza vaccine (aIIV4)Standard-dose trivalent inactivated influenza vaccine (SD-IIV3)

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.

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Asan Medical Center Seoul South Korea Recruiting

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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 NCT07485855 on ClinicalTrials.gov ↗ ← All trials in South Korea