Does booster influenza vaccination improve vaccination efficacy in patients with quiescent systemic lupus erythematosus?
- Conditions
- systemic lupus erythematosus (SLE)SLE is a systemic autoimmune disease.MedDRA version: 9.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemic
- Registration Number
- EUCTR2007-004579-21-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients
- patients have to fulfil international disease criteria of SLE
- quiescent disease, defined as SLEDAI =5
- informed consent
Healthy controls
- informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patients
- active disease, defined as SLEDAI >5
- use of prednisone >30 mg/day
- pregnancy
- malignancy
- no informed consent
Healthy controls
- use of immunosuppressives
- malignancy
- pregnancy
- no informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method