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Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years

Last updated on March 15, 2019

Study Location
Grieskirchner Strasse 17
Wels, , 4600 Austria
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Tick-borne Encephalitis
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-15 year
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Male and female children and adolescents will be eligible for participation in this study

- they are aged 1 year (from the 1st birthday) to 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

- 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;

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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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
immunological functions;

- are known to be HIV positive (a special HIV test is not required for the purpose of
the study);

- 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.

Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years


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