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RECRUITING
NCT07485855
PHASE3

Influenza Vaccination Strategy for Patients With Hematologic Malignancy

Sponsor: Asan Medical Center

View on ClinicalTrials.gov

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

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