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FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years

Last updated on May 9, 2019

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Study Location
Zespol Opieki Zdrowotnej w Debicy
Debica, , 33-200 Poland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tick-borne Encephalitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-66 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Received two vaccinations during the course of Baxter study 208

- Understand the nature of the study, agree to its provisions and give written informed
consent

- For volunteers under 18 years of age - written informed consent of the parents/legal
guardian is given

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- None.

Volunteers assessed for eligibility to receive a third vaccination.

Eligibility to receive third vaccination:

- ELISA value > 126 VIE U/ml before the first TBE vaccination in Baxter study 208

- 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 since receiving the
two vaccinations in Baxter study 208

- Have had an allergic reaction to one of the components of the vaccine since the last
vaccination in Baxter study 208

- 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 a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week
or equivalent dose of other alcoholic beverages)

- Have received banked human blood or immunoglobulins within one month of study entry

- Are known to have become infected with HIV (a special HIV test is not required for the
purpose of the study) since the last visit of study 208

- Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the
last visit in study 208

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

- Have a positive pregnancy test at the first medical examination (for females capable
of bearing children)

- Do not agree to employ adequate birth control measures for the duration of the study
(for females capable of bearing children)

NCT00161876
Pfizer
Completed
FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years

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