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Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years

Last updated on March 14, 2019

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Study Location
SGS Biopharma Research Unit Stuivenberg
Antwerp, , 2060 Belgium
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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- Understanding the nature of the study, agreement to its provisions and written
informed consent

- Written informed consent of subject´s parents / legal guardians (if subject is under
18 years of age)

- Aged >= 16 years (from the 16th birthday) to 66th birthday)

- Clinically healthy, (i. e. the physician would have no reservations vaccinating with
FSME-IMMUN 0.5 ml outside the scope of a clinical trial)

- Negative pregnancy test result at the first medical examination (if female and capable
of bearing children)

- Agreeing to employ adequate birth control measures for the duration of the study (if
female and capable of bearing children)

- Agreeing 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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- History of any previous TBE vaccination

- History of TBE infection

- History of infection with other flaviviruses

- History of vaccination against yellow fever and/or Japanese B-encephalitis

- History of allergic reactions, in particular to one of the components of the vaccine

- Suffering from a disease (e.g. autoimmune disease) or undergoing a form of treatment
(e.g. systemic corticosteroids) that can be expected to influence immunological
functions

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

- Donation of blood or plasma within one month of study start

- Having received a blood transfusion or immunoglobulins within one month of study entry

- HIV positivity (an HIV test is not required specifically for the purpose of this study

- Simultaneous participation in another clinical trial including administration of an
investigational product

- Participating in any other clinical study within six weeks prior to study start

- Participated in another Baxter vaccine study within the last six months (with the
exception of follow-up studies)

- Pregnancy or lactation (if female)

- Having received any other vaccination within two weeks prior to study entry

NCT00161954
Pfizer
Completed
Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years

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