Status:
COMPLETED
Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years
Lead Sponsor:
Pfizer
Conditions:
Encephalitis, Tick-borne
Eligibility:
All Genders
16-65 years
Phase:
PHASE4
Brief Summary
The objective of this study is to establish the earliest time point at which vaccines are expected to show seropositive antibody levels after vaccination with FSME-IMMUN 0.5 mL using a rapid immunizat...
Eligibility Criteria
Inclusion
- 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 \<= 65 years (to the last day before the 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00161954
Start Date
March 1 2004
End Date
May 1 2004
Last Update
May 21 2015
Active Locations (1)
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1
SGS Biopharma Research Unit Stuivenberg
Antwerp, Belgium, 2060