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Influenza Vaccination Strategy for Patients With Hematologic Malignancy

NCT07485855 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-24

No results posted yet for this 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

Conditions

  • Hematologic Neoplasms
  • Influenza
  • Immunogenicity

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.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Sung-Han Kim, MD, PhD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-04
Primary Completion
2027-04-30
Completion
2028-04-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07485855 on ClinicalTrials.gov