Tick-Borne Encephalitis (TBE) Seropersistence After First Booster and Response to a Second Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401)
Condition: Encephalitis, Tick-Borne
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Intervention: FSME-IMMUN 0.25 mL Junior (1.2 µg TBE antigen/0.25 mL) or FSME-IMMUN 0.5 mL (2.4µg TBE antigen/0.5 mL)
Intervention description: Dosage form: solution/suspension; injectable. Dosage frequency: once. Mode of administration: intramuscular.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 179.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to assess the seropersistence of TBE virus antibodies in
      children, adolescents and young adults who received the first booster vaccination with either
      FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL in precursor Study 700401.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects who participated in precursor Study 700401 and meet ALL of the following criteria
        are eligible for participation in this study:

          -  Subject / parent(s) / legal guardian(s) provide(s) written informed consent (according
             to national law);

          -  Subject provides written assent to the study according to age and capacity of
             understanding;

          -  Subject received the first booster vaccination with either FSME-IMMUN 0.25 ml Junior
             or FSME-IMMUN 0.5 ml during the course of precursor Study 700401;

          -  Blood was drawn after the first booster vaccination in precursor Study 700401;

          -  Subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is /
             are willing to comply with the requirements of the protocol (e.g. return for follow-up
             visits, completion of the Subject Diary).

        Exclusion Criteria:

        Subjects who participated in precursor Study 700401 and meet ANY of the following criteria
        are not eligible for participation in this study:

          -  Subject received any TBE vaccination since his / her first booster vaccination in
             precursor Study 700401;

          -  Subject has a history of infection with or vaccination against other flaviviruses
             (e.g. Dengue fever, yellow fever, Japanese B encephalitis) since his / her first
             booster vaccination in precursor Study 700401;

          -  Subject is known to be HIV positive since his / her first booster vaccination in
             precursor Study 700401 (a special HIV test is not required for the purpose of the
             study);

          -  Subject received a blood product or immunoglobulins within 90 days before any blood
             draw or in the period between the blood draw and the booster vaccination (as
             applicable);

          -  Subject has a known or suspected problem with drug or alcohol abuse (> 4 liters of
             wine/week or equivalent level of other alcoholic beverages);

          -  Subject / parent(s) / legal guardian(s) is / 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 the site conducting the study.