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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)

Phase 1
Recruiting
Conditions
Hematological cancer
Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Registration Number
CTIS2023-505357-40-00
Lead Sponsor
CHU De Liege
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
180
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

Exclusion Criteria

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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