CRA-TBE
- Conditions
- Tick-borne encephalitisMedDRA version: 21.1Level: LLTClassification code: 10077096Term: Tick-borne encephalitis immunization Class: 10042613Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2023-509575-16-00
- Lead Sponsor
- Vaestra Goetalandsregionen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
The subject has given their written consent to participate in the clinical trial., Male and female research participants above or equal to 18 years of age.
Women with ongoing pregnancy or breast feeding without prior history of hospitalization for TBE or vaccination against TBEV., Inability or unwillingness to provide informed consent or abide by the requirements of the clinical trial., Evidence of allergy or other known adverse reaction to components are part of the TBE vaccine (FSME-IMMUN Vuxen) for unvaccinated participants planning to undergo vaccination against TBEV in the clinical trial., Having a bleeding disorder or receiving preventive anticoagulation therapy which prevents the vaccine being administered intramuscularly, for individuals without prior history of hospitalization for TBE or prior vaccination against TBEV.
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