Hematological cancer
Conditions
Brief summary
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
Detailed description
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
Interventions
Sponsors
CHU De Liege
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium
Outcome results
None listed