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Influenza Vaccination Strategy for Patients With Hematologic Malignancy

Study acronym: (HEM-FLU)
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment increased: 60 → 120 participantsv4
  2. Site contact updatedv3
  3. Study description expanded, about 203 words
    • Secondary endpoints expanded, about 2 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07485855
Lead Sponsor Asan Medical Center
Conditions
(from sponsor)		 Hematologic Neoplasms, Influenza, Immunogenicity
Related terms Hematologic Neoplasms, Influenza, Human
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov