Male and female children will be eligible for participation in this study if:
- they are aged >= 1 years (from the 1st birthday) to 11 years (to the last day before
the 12th birthday) at screening;
- their parents / legal guardians provide written informed consent;
- children provide written assent to the study according to age and capacity of
understanding;
- their parents/guardians understand the nature of the clinical study and will comply
with the requirements of the protocol (e.g., completion of the Subject Diary, return
for follow-up visits);
- they are generally healthy, (i.e. the physician would have no reservations vaccinating
with a TBE vaccine outside the scope of a clinical study);
- provide a negative pregnancy test result at the first medical examination (if the
subject is a female and capable of bearing children).
Subjects will be excluded from participation if:
- they have a history of any previous TBE vaccination;
- they have a history of TBE infection;
- they have a history of infection with other flaviviruses;
- they have a history of vaccination against yellow fever and/or Japanese B
encephalitis;
- they have a history of severe allergic reactions, in particular a known sensitivity or
allergy to any components of the vaccines;
- they are suffering from a disease (e.g. autoimmune disease) or are undergoing a form
of treatment (e.g. systemic corticosteroids) that can be expected to influence
immunological functions;
- they have received any blood product or immunoglobulins within 90 days prior to study
entry;
- they are known to be Human Immunodeficiency Virus (HIV) positive (an HIV test is not
required specifically for the purpose of this study);
- they have a functional or surgical asplenia;
- they have a rash or other dermatological condition at the injection site which could
interfere with injection site reaction evaluation;
- they were administered an investigational product within six weeks prior to study
start or are concurrently participating in another clinical study that includes the
administration of an investigational product;
- they are pregnant or breastfeeding (if a female subject);
- they or their parents/legal guardian(s) are in a dependent relationship with the study
investigator or with a study team member. Dependent relationship includes close
relatives (i.e., children or grandchildren, partner/spouse, siblings) as well as
employees of the investigator or site conducting the study.
- Subjects who have an acute illness with or without elevated body temperature
(>=37.5°C) within 3 days prior to the scheduled first vaccination will not be
vaccinated. Subjects may be included at a repeat visit provided that (1) the illness
has resolved (body temperature
calendar days after the Screening Visit, and (3) the center is still open for
recruitment.
- If subjects have received antipyretics within 4 hours prior to the scheduled time of
vaccination, the vaccination should be performed at a later date, as long as the
center is still open for recruitment.
- Subjects who received any live vaccine within 4 weeks or any inactivated vaccine
within 2 weeks prior to the scheduled first study vaccination will not be vaccinated
until an interval of 4 or 2 weeks, respectively, has passed, provided the center is
still open for recruitment.
- If a subject was bitten by a tick within 4 weeks prior to the scheduled first or
second vaccination, the vaccination must be postponed until an interval of 4 weeks has
passed.