All volunteers who participated in Baxter study 199 and received two vaccinations will be
invited to participate. Male and female children will be eligible for participation in
this study if:
- They received two vaccinations with one of the three different dosages of FSME IMMUN
NEW during the course of Baxter study 199
- Written informed consent from the legal guardian is available.
There are no specific exclusion criteria for this study entry. However volunteers will be
assessed for eligibility to receive a third vaccination.
Volunteers will be excluded from vaccination and consecutive visits in this study if they:
- Are not clinically healthy, (i. e. the physician would have reservations vaccinating
with FSME IMMUN NEW outside the scope of a clinical trial)
- Have already been administered a third TBE vaccination elsewhere after the two
vaccinations in Baxter study 199
- Have had an allergic reaction to one of the components of the vaccine since the last
vaccination in Baxter study 199
- Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment
(e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence
immunological functions
- Have received banked human blood or immunoglobulins within one month of study entry
- Are known to be HIV positive (a special HIV test is not required for the purpose of
the study) since the last visit of Baxter study 199
- Have had a vaccination against yellow fever and / or Japanese B-encephalitis since
the last visit in Baxter study 199
- Had received an investigational new drug within 6 weeks prior to study start