Tick-borne encephalitis
Conditions
Interventions
Trade Name: FSME-IMMUN 0,25 ml Junior (Please be aware that FSME-IMMUN 0,25 ml Junior was given outside of the scope of this study and in this study only a blood drawing is planned without administrat
Sponsors
Baxter Vaccine AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female children who participated in Study IMAG-146A will be eligible for participation in this study if: - they and/or their parents/legal guardians understand the nature of the study and agree to its provisions; - written informed consent is available from the child (according to age and capacity of understanding) and the parents/legal guardians; - they received the complete 3-immunization primary vaccination series with either 0.5 ml or 0.25 ml TicoVac in Study IMAG-146A; - they received FSME-IMMUN 0.25 ml Junior for their first booster vaccination approximately 3 to 4 years after their third vaccination in Study IMAG-146A. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will be excluded from participation in this study if: - they have received any further TBE vaccination since their first TBE booster vaccination; - they have a history of infection with, or vaccination against, other flaviviruses (e.g. dengue fever, yellow fever and/or japanese B encephalitis virus) since their third vaccination in Study IMAG-146A; - they suffered from a disease (e.g. autoimmune disease) or have undergone a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions within 30 days before and after their first TBE booster vaccination; - they are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination in Study IMAG-146A; - they have received a blood transfusion or immunoglobulins within 30 days of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Seropositivity rate, measured by ELISA and/or NT (according to Adner et al., 2001), approximately 3 years after the first booster vaccination with FSME-IMMUN 0.25 ml Junior;Secondary Objective: - Seropositivity rate, measured by ELISA, approximately 3 years after the first booster vaccination with FSME-IMMUN 0.25 ml Junior; - Seropositivity rate, measured by NT according to Adner et al., 2001, approximately 3 years after the first booster vaccination with FSME-IMMUN 0.25 ml Junior; - Seropositivity rate, measured by NT according to Holzmann et al., 1996, approximately 3 years after the first booster vaccination with FSME-IMMUN 0.25 ml Junior; - Antibody concentration approximately 3 years after the first booster vaccination with FSME-IMMUN 0.25 ml Junior as measured by ELISA; - Antibody titer approximately 3 years after the first booster vaccination with FSME-IMMUN 0.25 ml Junior as measured by NT according to Adner et al., 2001; - Antibody titer approximately 3 years after the first booster vaccination with FSME-IMMUN 0.25 ml Junior as measured by NT according to Holzmann et al., 1996. ;Primary end point(s): - Seropositivity rate, measured by ELISA and/or NT (according to Adner et al., 2001), approximately 3 years after the first booster vaccination with FSME-IMMUN 0.25 ml Junior | — |
Countries
Austria
Outcome results
None listed