tbe antibody persistence and booster vaccination study in adults (follow-up to study 223)

Conditions: Encephalitis, Tick-Borne

Summary: the purpose of this study is to assess: * tbe antibody persistence 24, 34, 46 and 58 months (as applicable) after the first booster tbe vaccination with fsme-immun 0.5ml given in study 223, by means of elisa (immunozym fsme igg) and neutralization test (nt), * tbe antibody response to a second booster vaccination with fsme-immun 0.5ml in the present study, by means of elisa and nt, * safety of fsme-immun 0.5ml after the second booster vaccination.


Eligibility criteria:
inclusion criteria: * subjects who participated in study 223 will be eligible for participation in this study if: * they understand the nature of the study, agree to its provisions and provide written informed consent * they received the first booster vaccination with fsme-immun 0.5ml during the course of study 223 * blood was drawn after their first booster vaccination in study 223. exclusion criteria: subjects will be excluded from participation in this study if they: * received any tbe vaccination since their first booster vaccination with fsme-immun 0.5ml * have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, japanese b-encephalitis) since their first booster vaccination with fsme-immun 0.5ml * are known to be hiv positive (a special hiv test is not required for the purpose of the study) since their first booster vaccination with fsme-immun 0.5ml * have a known or suspected problem with drug or alcohol abuse (\> 4 liters wine / week or equivalent level of other alcoholic beverages). subjects will not be eligible for booster vaccination if they: * are not clinically healthy, (i. e. the physician would have reservations vaccinating with fsme-immun 0.5ml outside the scope of a clinical trial) * suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions * are females of childbearing potential and are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination) * have shown an allergic reaction to one of the components of the vaccine since their first booster vaccination in study 223 * are simultaneously participating in another clinical trial including administration of an investigational product within six weeks prior to the booster vaccination until the end of the study * do not agree to keep a subject diary. * subjects who meet the eligibility criteria, but have a febrile illness (body temperature \>= 38.0°c, measured orally) at the scheduled time of vaccination, will not be vaccinated until their body temperature returns to normal. * subjects who have been administered any vaccination within 2 weeks prior to the booster vaccination will not be vaccinated until an interval of two weeks has passed. * if subjects have received antipyretics within 4 hours prior to the scheduled time of vaccination, the vaccination should be performed at a later time. * if a subject had a tick-bite within 4 weeks of the scheduled booster vaccination, the vaccination shall be delayed such that an interval of 4 weeks has passed since the tick-bite in order to avoid any interference with diagnostic assays in the event of a tbe infection. * if a subject has donated blood or plasma or has received a blood transfusion or immunoglobulins within 4 weeks of the scheduled booster vaccination, the vaccination shall be delayed until an interval of 4 weeks has passed.