CTIS2023-509575-16-00
Active, not recruiting
Phase 1
ow-Intervention Clinical Trial Evaluating a Novel Cytokine Release Assay for Tick-Borne Encephalitis (TBE) Among Healthy and Immunosuppressed Research Participants - 2023-509575-16-00
Vaestra Goetalandsregionen0 sites100 target enrollmentFebruary 12, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Tick-borne encephalitis
- Sponsor
- Vaestra Goetalandsregionen
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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