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)

INTERVENTION: Product Name: Alpharix‐Tetra, suspension injectable en seringue préremplie Vaccin antigrippal (virion fragmenté, inactivé),Product Code: PRD1700265,Pharmaceutical Form: SUSPENSION FOR INJECTION,Other descriptive name: ,Strength: B/Phuket/3073/2013‐Like Virus (B/Phuket/3073/2013, Wild Type) 15µg HA / 0.5mL, A/Darwin/9/2021 (H3n2) ‐ Like Strain (A/Darwin/6/2021, Ivr‐227) 15µg HA / 0.5mL, Influenza Virus B/Austria/1359417/2021‐Like Strain (B/Austria/1359417/2021, Bvr‐26) 15µg HA / 0.5mL, A/Victoria/2570/2019 (H1n1)Pdm09‐Like Strain (A/Victoria/2570/2019, Ivr‐215) 15µg HA / 0.5mL,Product Name: EFLUELDA, suspension injectable en seringue préremplie Vaccin grippal quadrivalent (inactivé, à virion fragmenté), 60 microgrammes HA/souche,Product Code: PRD7991555,Pharmaceutical Form: SUSPENSION FOR INJECTION,Other descriptive name: ,Strength: Influenza Virus B/Michigan/01/2021 60µg HA / 0.7mL, B/Phuket/3073/2013‐Like Virus (B/Phuket/3073/2013, Wild Type) 60µg HA / 0.7mL, Influenza Virus A/Darwin/9/2021 Ivr‐228 (H3n2) 60µg HA / 0.7mL, A/Victoria/2570/2019 (H1n1)Pdm09‐Like Strain (A/Victoria/2570/2019, Ivr‐215) 60µg HA / 0.7mL CONDITION: Hematological cancer Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20]‐Diseases [C] ‐ Hemic and Lymphatic Diseases [C15] PRIMARY OUTCOME: Main Objective: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. Primary end point(s):First co‐primary endpoint : the primary endpoint will be to compare seroconversion to a least one of the four vaccine antigens at 28 days after vaccination in patients randomized in the QIIV‐HD versus QIIV‐SD vaccine (see 6.3 for the definition of response),Second co‐primary endpoint : to define a baseline signature predicting response to the vaccine Secondary Objective: SECONDARY OUTCOME: Secondary end point(s):To compare response to QIIV‐HD versus QIIV‐SD vaccine for : • Seroconversion rate for the 4 vaccine antigens, • Partial and complete seroprotection rates, • Systemic and local adverse events occurring in the 6 months following vaccination, • Seroconversion to at least one of the four antigens in the 3 groups (multiple myeloma, other B‐cell malignancy and myeloid malignancy), • Factors associated with response to the vaccine INCLUSION CRITERIA: 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