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 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT03971058
Eligibility Criteria:
Inclusion Criteria:
* participation in the preceeding study "IXIARO®-senescence" (EudraCTno: 2010-018630-52) without protocoll violation OR 2 documented IXIARO® vaccinations 28 days (-8/+ 30 days) apart between January 2010 and April 2014 at the age of 18 to 40 years or above the age of 60.
* good state of health including individuals with medically controlled minor underlying disease (such as hypertension, hypercholesterinemia, NIDDM)
* willingness to sign written informed consent
major Exclusion Criteria:
* Already received an booster (3rd dose) of IXIARO ®
* Vaccination with other JE vaccine (e.g. Je-vax)
* clinically manifest infection with another Flavivirus within 1 year prior study inclusion (yellow fever, Dengue fever, West Nile, TBE)
* past infection with the JEV
* vaccination against yellow fever, Dengue, West Nile within 6 months prior to study inclusion
* TBE vaccination within the last 30 days prior to study inclusion
* immunosuppressive therapy (intake\>14d) within 30 days before IXIARO booster till V3 (day 42+/-4), Corticosteroids like Prednisolon \> and = 20mg/day; allowed: topic or inhalative application
* immunodeficiency or st. p. organ transplantation
* autoimmune disease except vitiligo or diseases of the thyroid gland with thyroid hormon substitution therapy
* immuntherapy within 2 weeks before or after Ixiaro Booster
* current acute infection or exacerbation of a chronic illness
* cancer within the last 5 years
* clinically significant haematological, renal, pulmonary, hepatic, neurological, cardiovascular disease which is not treated adequately within 12 weeks before Ixiaro booster
* known infection with HIV, Hep B and Hep C
* Guillain - Barré- Syndrome (GBS) - anamnestic
* anamnestic anaphylaxie, atopy oder severe hypersensivity against ingredients of IXIARO
* drug abuse/alcohol abuse
* pregnancy and breastfeeding
* plasma donation within the last 4 months
* receiving blood or immunglobulins within 3 months before v1
* significant mental disorder
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03971058
Study Brief:
Protocol Section:
NCT03971058