- Understanding the nature of the study, agreement to its provisions and written
informed consent
- Written informed consent of subject´s parents / legal guardians (if subject is under
18 years of age)
- Aged >= 16 years (from the 16th birthday) to 66th birthday)
- Clinically healthy, (i. e. the physician would have no reservations vaccinating with
FSME-IMMUN 0.5 ml outside the scope of a clinical trial)
- Negative pregnancy test result at the first medical examination (if female and
capable of bearing children)
- Agreeing to employ adequate birth control measures for the duration of the study (if
female and capable of bearing children)
- Agreeing to keep a subject diary.
- History of any previous TBE vaccination
- History of TBE infection
- History of infection with other flaviviruses
- History of vaccination against yellow fever and/or Japanese B-encephalitis
- History of allergic reactions, in particular to one of the components of the vaccine
- Suffering from a disease (e.g. autoimmune disease) or undergoing a form of treatment
(e.g. systemic corticosteroids) that can be expected to influence immunological
functions
- Known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or
equivalent level of other alcoholic beverages)
- Donation of blood or plasma within one month of study start
- Having received a blood transfusion or immunoglobulins within one month of study
entry
- HIV positivity (an HIV test is not required specifically for the purpose of this
study
- Simultaneous participation in another clinical trial including administration of an
investigational product
- Participating in any other clinical study within six weeks prior to study start
- Participated in another Baxter vaccine study within the last six months (with the
exception of follow-up studies)
- Pregnancy or lactation (if female)
- Having received any other vaccination within two weeks prior to study entry