NCT07485855 Influenza Vaccination Strategy for Patients With Hematologic Malignancy
| NCT ID | NCT07485855 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Asan Medical Center |
| Condition | Hematologic Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-04 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2025-12-04 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Sung-Han Kim, MD, PhD
PRINCIPAL INVESTIGATOR
Asan Medical Center
Frequently Asked Questions
Who can join the NCT07485855 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Hematologic Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07485855 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT07485855 currently recruiting?
Yes, NCT07485855 is actively recruiting participants. Contact the research team at soyun_lim@amc.seoul.kr for enrollment information.
Where is the NCT07485855 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07485855 clinical trial?
NCT07485855 is sponsored by Asan Medical Center. The principal investigator is Sung-Han Kim, MD, PhD at Asan Medical Center. The trial plans to enroll 60 participants.