NCT00163540CompletedPhase 4
Open-Label, Follow-up, Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated Using a Rapid Immunization Schedule (Follow-up to Study 225)
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Pfizer
- Locations
- 1
Study Overview
Brief Summary
The objective of this study is to investigate the immunogenicity and safety of a third vaccination with FSME-IMMUN 0.5 ml given approximately 12 months after the second vaccination in Study 225. In Study 225, two vaccinations were given using a rapid immunization schedule 12 ± 2 days apart.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 17 Years to 66 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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
Investigators
Study Sites (1)
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