ABOUT THIS STUDY
Male and female children will be eligible for participation in this study if:
- they are 6 years (from the 6th birthday) to 16 years old (to the last day before the 16th birthday);
- they are clinically healthy;
- their legal representative - and if older than 8 years the volunteer - understands the nature of the study, agrees to its provisions and gives written informed consent;
- their legal representative agrees to keep a Volunteer Diary.
For safety reasons female volunteers capable of bearing children have to fulfill the following inclusion criteria at study start:
- negative pregnancy test at study start;
- they agree to employ adequate birth control measures for the duration of the study.
Children will be excluded from participation in this study if they:
- have a history of any previous TBE vaccination;
- have a history of TBE infection or show evidence of a latent TBE infection (as
demonstrated by screening ELISA > 126 VIEU/ml and / or neutralization test > 1:10);
- have a history of allergic reactions, in particular to one of the components of the
- have received antipyretics within 4 hours prior to the first TBE vaccination;
- suffer from a disease that cannot be effectively treated or stabilized;
- suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment
that can be expected to influence immunological functions;
- suffer from chronic, degenerative and / or inflammatory disease of the central nervous
- are known to be HIV positive (a special HIV test is not required for the purpose of
- suffer from a febrile illness at study entry;
- have a history of vaccination against yellow fever and / or Japanese B-encephalitis;
- are participating simultaneously in another clinical trial.
- if female, are pregnant or breast feeding
Volunteers who meet the inclusion / exclusion criteria, but have a febrile illness (body
temperature >= 38° C, measured orally) at the scheduled time of vaccination, will not be
vaccinated before their body temperature returns to normal.
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