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:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT01072734
Eligibility Criteria:
Inclusion criteria :
* 18 years of age and older
* informed consent signed
* LES patients who meet the American College of Rheumatology (ACR) diagnostic criteria of SLE
* Patient able to attend all visit schedule during the month following influenza vaccine administration
* Clinical examination performed prior final inclusion with results communicated to the patient
Exclusion criteria :
* For women, being pregnant or positive pregnancy test
* Positive for HCV, HIV and HBV
* Patient treated with rituximab (anti-CD20) or stopped for less than a year.
* Patient for whom a treatment majorization is suspected within the month following influenza vaccine administration.
* Hypersensitivity to active substances, eggs and to one of the vaccine components
* Other vaccinations within the last 30 days before the inclusion at J0
* Administration of blood products such as immunoglobulins within the last 90 days before J0
* Progressive cancer, cirrhoses
* Acute severe illness within the last 30 days before inclusion at J0
* Patient non affiliated to a health social security system
* Planned participation to another clinical study during the present study period
* patient deprived of freedom by an administrative or court order
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01072734
Study Brief:
Protocol Section:
NCT01072734