Male and female volunteers were eligible for participation in this study if they:
- Were 16 years (from the 16th birthday) to 65 years (to the last day before the 65th
birthday) old
- Were clinically healthy
- Had a negative pregnancy test at the first medical examination, if female and capable
of bearing children
- Agreed to employ adequate birth control measures for the duration of the study, if
female and capable of bearing children
- Provided written informed consent
- For volunteers under 18 years of age - written informed consent of the parents /
guardian was available
- Agreed to keep a volunteer diary
- History of any previous TBE vaccination
- History of TBE infection or show evidence of latent TBE infection (as demonstrated by
screening ELISA > 126 VIEU/ml)
- History of allergic reactions, in particular to one of the components of the vaccine
- Previously received volume substitution with a product containing polygeline
(stabilizer in ENCEPUR)
- Received antipyretics within 4 hours prior to the first TBE vaccination
- Suffer from a disease that cannot be effectively treated or stabilized
- Suffering from a disease (e.g. autoimmune disease) or were undergoing any form of
treatment that could be expected to influence immunological functions
- Suffering from chronic, degenerative and/or inflammatory disease of the central
nervous system
- Using any immunosuppressive drugs (e.g. local or systemic corticosteroids,
chemotherapeutics)
- Had a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or
equivalent level of other alcoholic beverages)
- Had donated blood or plasma within one month of the study start
- Had received banked blood or immunoglobulins within one month of study entry
- Known to be HIV positive (a special HIV test was not required for the purpose of the
study)
- Suffering from a febrile illness at study entry
- History of vaccination against yellow fever and / or Japanese B encephalitis
- Participating simultaneously in another clinical trial
- If female: pregnant or breast feeding