immunogenicity, safety and interchangeability of two tbe vaccines administered according to a conventional schedule in children

Conditions: Encephalitis, Tick-Borne

Summary: the objective of this study is to assess the immunogenicity, safety and interchangeability of two different tbe vaccines in children aged 1-11 years, the first and second vaccination with either fsme-immun 0.25ml junior or encepur 0.25ml children and the third vaccination with fsme-immun 0.25 ml junior only, administered according to the conventional schedule (0, 28 and 360 days).


Eligibility criteria:
inclusion criteria: 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). exclusion criteria: 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 \< 37.5 °c), (2) the repeat visit is no more than 14 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.