Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children
Condition: Encephalitis, Tick-Borne
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Intervention: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated); Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Intervention description: Subjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360; Subjects receive two vaccinations with Encepur 0.25ml Children on days 0 and 28 and a third vaccination with FSME-IMMUN 0.25ml Junior on day 360.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Masking: Single (Participant)
Enrollment: 302.0
Sex: All
Minimum age: 1 Year
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers

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.