Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT04952766
Eligibility Criteria:
Inclusion Criteria:
* Adult volunteers to be vaccinated with the ComirnatyTM vaccine and to participate in the study, belonging to one of the following groups:
* Group of immunocompromised (15 participants per immunosuppression subgroup):
* Kidney transplant
* Extracorporeal dialysis
* Solid cancer under chemotherapy and / or radiotherapy
* Myeloma under chemotherapy
* Hematologic malignancies under chemotherapy
* Diseases treated with anti CD20 (or patients not treated at the time of the vaccine but who will be immediately after)
* Multiple sclerosis under anti CD20 (or patients not treated at the time of the vaccine but who will be immediately after)
* Common variable immune deficiency or other causes of severe hypogammaglobulinemia requiring chronic treatment with polyvalent immunoglobulin
* Malignant tumor under anti-PD1 or anti-PDL1
* People living with HIV
* Complicated type 2 diabetes (with micro and / or macroangiopathy)
* Group of non-immunocompromised subjects (controls, n = 75)
* 60 people vaccinated with the ComirnatyTM
* 15 people vaccinated with Astra Zeneca's VaxzevriaTM for the first dose
Exclusion Criteria:
* Minors
* Pregnant or breastfeeding women
* Persons under tutorship or curatorship
* Protected adults
* Person under legal protection
* Person not affiliated to a social security scheme
* People with a contraindication to receiving the ComirnatyTM vaccine
* People who have already been vaccinated against SARS-CoV-2
Note: a history of COVID-19 (\> at 3 months) is not a contraindication to vaccination and is therefore not a criterion for non-inclusion in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04952766
Study Brief:
Protocol Section:
NCT04952766