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Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR

Last updated on March 11, 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
16-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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

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

NCT00161824
Pfizer
Completed
Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR

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