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).
Who can participate
Age range1 Year – 11 Years
SexALL
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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 functio…
What they're measuring
1
Seropositivity Rate as Determined by Neutralization Test (NT) 28 Days After the Second Vaccination