Prospective, randomized, doubleblind, placebo-controlled trial on changes in acetylcholine receptor antibody titres in autoimmune myasthenia gravis after influenza vaccination (ProPATIent) - ProPATIent
- Conditions
- Generalized Myasthenia gravis with positive antibodies against Acetylcholine-receptors (ICD10GM2006 G70.0)
- Registration Number
- EUCTR2006-004374-27-DE
- Lead Sponsor
- Philipps-University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
written informed consent
age 18-80
diagnosis of a generalized Myasthenia gravis (ICD10GM2006: G70.0)
positive Acetylcholine receptor antibodies
stable clinical course for at least 4 weeks before inclusion in the study
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) yes
F.1.3.1 Number of subjects for this age range
contraindication for Mutagrip according to the Fachinformation
any vaccination in the last 9 months prior to study entry
serious or acute heart disease (e. g. uncontrolled cardiac dysrhythmias, angina pectoris, cardiomyopathy, congestive heart failure)
known allergy to chicken proteins, neomycine, formaldehyde, Octoxinol 9)
current infection or current pyrexia
pregnancy
history of cancer
severe adverse event in earlier vaccination
current participation in another clinical trail
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