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A Single-Blind randomized trial of High-Dose versus Standard-Dose Inactivated Influenza Vaccine in Adult Patients Treated for an Hematological Cancer (Flu-Hemato-Rando study)
EU CTIS ID: 2023-505357-40-00
What this study is testing
The two main aims of the study are : - 1) A phase III, single center, randomized trial of QIIV-HD versus QIIV-SD vaccine in patients treated with an hematological cancer. A total of 140 patients will be recruited. Patients will be blinded for the vaccine received. The primary endpoint will be seroconversion to a least one of the four vaccine antigens. The hypothesis is that the seroconversion rate will increase from 40% in QIIV-SD patients to 65% in QIVV-HD patients. Randomization will be stratified for disease group (we aim at recruiting approximately 80 myeloma patients, 40 other B-cell malignancy patients and 20 patients treated for a myeloid malignancy). - 2) A systems biology study aimed at defining a baseline signature predicting response to the vaccine as well as comparing activation of the immune system in patients included in the randomized study as well as in 40 healthy control subjects.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients under treatment for: a multiple myeloma, or a B-cell malignancy (including patients given rituximab in the 6 months prior to vaccine even if no additional treatment given)., or a myeloid malignancy (hydroxyurea or tyrosine kinase inhibitors are not be considered as a “treatment” for the current study in contrast to JAK inhibitors or azacitidine) or standard chemotherapy
- Age > or = 18 years at inclusion
- Written informed consent
You likely can't join if
- HIV seropositivity
- Pregnancy
- Egg allergy or allergy to previous influenza vaccine
- IVIg in the past 30 days or planning to receive IVIg in the 4 weeks after vaccination
- Prior post-transplant IIV vaccination in the same season
- Severe Heart failure (ejection fraction < 35%) at the last examination
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.