Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
NCT ID:
NCT00461695
Eligibility Criteria:
Inclusion criteria:
* Age \> 70 years
* Healthy according to a health questionnaire (completed before screening)
* TBE-Vaccination indicated (exposure to TBEV-infested ticks possible)
* Capable to make an informed decision and to understand the informed consent form
* Informed consent signed by patient and study physician
Exclusion criteria:
* Previous exposure to TBEV (natural or vaccination)
* Immunodeficiency, history of autoimmune disease or current intake of immune-modulating drugs (corticosteroids a.s.o.)
* Persistent (\> 3 months) pharmacological treatment with more than one drug of relevance (exception: combination antihypertensives)
* Contraindication for TBEV-vaccination
* Condition that would drastically interfere with clinic attendance and/or adherence to the protocol
* Past medical history or current treatment for one of the following conditions: Chronic cardiac disease (Coronary heart disease, heart failure), chronic pulmonary disease (COPD), chronic kidney disease, diabetes mellitus, previous stroke, epilepsy, Parkinsons disease, dementia
* Hemoglobin \<12 g/l
* Random plasma glucose (RPG) \> 11.1 mmol/l OR fasting plasma glucose (FPG) \> 6.9 mmol/l (FPG required, if RPG is 7.0-11.0 mmol/l)
* Calculated Creatinin-Clearance \< 50 ml/min
* TBEV-serology positive
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT00461695
Study Brief:
Protocol Section:
NCT00461695