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FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years

Last updated on March 15, 2019

Study Location
Neuschwanstein Strasse 5
Augsburg, , D-86163 Germany
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Tick-borne Encephalitis
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-16 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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All volunteers who participated in Baxter study 205 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 205

- They and/or their legal guardian understand the nature of the study, agree to its
provisions and give written informed consent

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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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 205

- Have had an allergic reaction to one of the components of the vaccine since the last
vaccination in Baxter study 205

- 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 205

- Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the
last visit in Baxter study 205

- Had received an investigational new drug within 6 weeks prior to study start

- If female and capable of bearing children - have a positive pregnancy test at the
first medical examination

FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years


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