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Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule

Last updated on March 14, 2019

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Study Location
Centrum Badan Farmakologii Klinicznej monipol
Krakow, , 30-969 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 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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.

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

NCT00460486
Pfizer
Completed
Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule

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