Encephalitis, Tick-borne
Conditions
Keywords
Tick-Borne Encephalitis
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 immunization schedule (2 vaccinations administered 12 +/- 2 days apart.
Interventions
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Countries
Belgium
Outcome results
None listed