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:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT01991067
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects will be eligible for participation in this study if they:
* Are ≥18 years on the day of screening
* Had undergone an allogeneic HSCT 11 to 13 months ago (study population)
* Are clinical healthy without previous TBE vaccination (control group)
* Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
* If female and capable of bearing children - have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study
Exclusion Criteria:
* Subjects will be excluded from participation in this study if they:
* Have received a TBE vaccination following HSCT
* Suffer from extremely severe acute graft-versus host disease and therefore receive prednisone \>0.5 mg/kg bodyweight as part of a combination therapy or a three agent immunosuppressive treatment (because in these HSCT patients any type of vaccination has to be postponed until immunosuppression is reduced to a double combination or prednisone \<0.5 mg/kg bodyweight)
* Suffer from or have a history of previous TBE virus infection or vaccination, previous dengue virus infection or vaccination against yellow fever or Japanese encephalitis
* Have any acute febrile illness in the 2 weeks prior to or at the time of enrolment
* Have a history of severe allergic reactions or anaphylaxis after vaccination
* If female, are pregnant or lactating.
* If belonging to the healthy control group, are immunosuppressed (suffer from or have a history of immune mediated diseases, long-term use of corticosteroids, hemodialysis, chronic renal insufficiency, liver cirrhosis Child-Pugh class C, hematooncological malignant disease, solid organ transplant, HSCT)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01991067
Study Brief:
Protocol Section:
NCT01991067