Male and female subjects 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 (assent if the subjects is under 18 years of age);
- Provide the written informed consent of their parents / legal guardian (if the subject
is under 18 years of age);
- Are aged >= 16 years (from the 16th birthday) at screening;
- Are clinically healthy, (i.e. the physician would have no reservations vaccinating
with FSME-IMMUN 0.5 ml outside the scope of a clinical trial);
- Have a negative pregnancy test result at the first medical examination (if female and
capable of bearing children);
- Agree to employ adequate birth control measures for the duration of the study (if
female and capable of bearing children);
- Agree to keep a Subject Diary.
Subjects will be excluded from participation in this study if they:
- Have a history of any previous tick-borne encephalitis (TBE) vaccination;
- Have a history of TBE infection;
- Have a history of infection with or vaccination against other flaviviruses (e.g.
dengue fever, yellow fever, Japanese B-encephalitis);
- Have a history of allergic reactions, in particular to one of the components of the
vaccine;
- 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;
- Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week
or equivalent level of other alcoholic beverages);
- Have donated blood or plasma within 30 days of study entry;
- Have received a blood transfusion or immunoglobulins within 30 days of study entry;
- Are known to be HIV positive (an HIV test is not required specifically for the purpose
of this study);
- Are simultaneously participating in another clinical trial including administration of
an investigational product;
- Have participated in any other clinical study within six weeks prior to study entry;
- Are pregnant or breastfeeding (if female);
- Are a member of the team conducting this study or are in a dependent relationship with
the study investigator. Dependent relationships include close relatives (i.e.,
children, partner/spouse, siblings, parents) as well as employees of the investigator.
- Have received any other vaccination within two weeks prior to study entry.