ABOUT THIS STUDY
Male and female children and adolescents will be eligible for participation in this study if:
- they are aged 1 year (from the 1st birthday) to < 16 years (to the last day before the 16th birthday);
- they are clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial);
- their parents/legal guardians understand the nature of the study and agree to its provisions;
- written informed consent is available from both parents/legal guardians,
- for Germany/Austria: additional written informed consent is available for children older than 8 years
- they or their parents/legal guardians agree to keep a volunteer diary.
For safety reasons, female volunteers who have reached sexual maturity at study start have to meet the following additional inclusion criteria:
- negative pregnancy test at study entry;
Children and adolescents will be excluded from participation in this study if they:
- have a history of any TBE vaccination;
- have a history of TBE infection;
- have a history of allergic reactions to one of the components of the vaccine;
- suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment
(e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence
- are known to be HIV positive (a special HIV test is not required for the purpose of
- have received banked blood or immunoglobulins within one month of study entry;
- have a history of vaccination against yellow fever and/or Japanese B-encephalitis;
- suffer from hemorrhagic diathesis;
- are participating simultaneously in another clinical trial;
- if female: are pregnant or breastfeeding.
Volunteers who meet the inclusion/exclusion criteria, but have a febrile illness (body
temperature > 38°C) at the scheduled time of vaccination, will not be vaccinated before
their body temperature returns to normal.
Volunteers who have received any other vaccination within 4 weeks prior to visit 1 will not
be vaccinated until an interval of 4 weeks has passed. In this case visit 1 will take place
If volunteers have received antipyretics within 4 hours prior to the intended TBE
vaccination, the vaccination should be performed at a later time.
Volunteers who have a positive TBE antibody value prior to the first vaccination will be
excluded from the statistical analysis of the primary endpoint.
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