Influenza Vaccination Strategy for Patients With Hematologic Malignancy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorAsan Medical Center
About this trial
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 criteria
Qualifiers
Adults aged 19 years or older
Disqualifiers
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
Trial design
Treatments tested in this trial
- High-dose trivalent inactivated influenza vaccine (HD-IIV3)
- MF59-adjuvanted quadrivalent inactivated influenza vaccine (aIIV4)
- Standard-dose trivalent inactivated influenza vaccine (SD-IIV3)
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov