Observational study on measles, mumps, and rubella vaccinations in children suffering from inflammatory bowel disease, autoimmune hepatitis or liver transplantatio
- Conditions
- K50.1K50.0K50.8K51.0K51.2K51.3K51.8Z94.4K75.4Crohn disease of large intestine
- Registration Number
- DRKS00014569
- Lead Sponsor
- Klinik für Kinder- und Jugendmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 21
As this is an observational study no inclusion criteria are defined. In principal, patients with chronic inflammatory bowel disease, autoimmune hepatitis and after liver transplantation being in steady state of there disease and having the indication of MMR vaccination due to insufficient protection against measles, mumps, and in female also rubella are included.
As this is an observational study no exclusion criteria are given for this study. Basically the recommendations from the enclosed leaflet have to be followed.
In addition, we made some recommendations in our observational protocol.
1) We need a parent or patient consent to collect and analyze the data in this study.
2) If the patient is suspicious for an immunodeficiency this should be clarified first.
3) In addition to the leaflet we do not recommend immunization during an active underlying disease
4) Furthermore, we specified some conditions that may affect safety and efficiency, which should be avoided. In detail these conditions are stated in the observational procotol.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of MMR vaccination using the immunological check list after 12-16 weeks
- Secondary Outcome Measures
Name Time Method Effectivity of vaccination with increment of vaccine specific antibody formation after 12-16 weeks