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Immunogenicity and Safety Study of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated According to a Rapid Immunization Schedule (Follow-up to Study 225)

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
17-66 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 who:

- received 2 vaccinations with FSME-IMMUN 0.5 ml during Study 225

- understand the nature of the study, agree to its provisions and provide written
informed consent

- are clinically healthy (i.e. the physician would have no reservation vaccinating with
FSME-IMMUN 0.5 ml outside the scope of the 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 who:

- have already been administered a third TBE vaccination elsewhere since receiving two
vaccinations in Study 225

- have a history of infection with, or vaccination against, other flaviviruses since
participation in Study 225 (e.g. yellow fever, dengue fever, japanese B encephalitis)

- have had an allergic reaction to one of the components of the vaccine since
participation in Study 225

- suffer from a disease (e.g. autoimmune disease, immunodeficiency) 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 doses 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 this study)

- are simultaneously participating in another clinical trial including administration of
an investigational product

- have participated in any other clinical study within 6 weeks prior to study start

- have participated in another Baxter vaccine study in the past 6 months (with the
exception of follow-up studies)

- For female subjects: pregnancy or lactation

NCT00163540
Pfizer
Completed
Immunogenicity and Safety Study of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated According to a Rapid Immunization Schedule (Follow-up to Study 225)

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