Encephalitis, Tick-borne
Conditions
Brief summary
The purpose of this study is to assess the safety of a vaccination schedule consisting of two vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN NEW (5 consecutive lots) in comparison to another licensed TBE vaccine (Encepur® adults, with polygeline) (2 lots) in healthy volunteers aged 16 to 65 years.
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Male and female volunteers were eligible for participation in this study if they: * Were 16 years (from the 16th birthday) to 65 years (to the last day before the 65th birthday) old * Were clinically healthy * Had a negative pregnancy test at the first medical examination, if female and capable of bearing children * Agreed to employ adequate birth control measures for the duration of the study, if female and capable of bearing children * Provided written informed consent * For volunteers under 18 years of age - written informed consent of the parents / guardian was available * Agreed to keep a volunteer diary
Exclusion criteria
* History of any previous TBE vaccination * History of TBE infection or show evidence of latent TBE infection (as demonstrated by screening ELISA \> 126 VIEU/ml) * History of allergic reactions, in particular to one of the components of the vaccine * Previously received volume substitution with a product containing polygeline (stabilizer in ENCEPUR) * Received antipyretics within 4 hours prior to the first TBE vaccination * Suffer from a disease that cannot be effectively treated or stabilized * Suffering from a disease (e.g. autoimmune disease) or were undergoing any form of treatment that could be expected to influence immunological functions * Suffering from chronic, degenerative and/or inflammatory disease of the central nervous system * Using any immunosuppressive drugs (e.g. local or systemic corticosteroids, chemotherapeutics) * Had a known or suspected problem with drug or alcohol abuse (\> 4 liters wine / week or equivalent level of other alcoholic beverages) * Had donated blood or plasma within one month of the study start * Had received banked blood or immunoglobulins within one month of study entry * Known to be HIV positive (a special HIV test was not required for the purpose of the study) * Suffering from a febrile illness at study entry * History of vaccination against yellow fever and / or Japanese B encephalitis * Participating simultaneously in another clinical trial * If female: pregnant or breast feeding
Countries
Poland
Outcome results
None listed