Tick-borne encephalitis
Conditions
Interventions
Pharmaceutical Form: Suspension for injection
Pharmaceutical Form: Suspension for injection
Sponsors
Baxter AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who participated in study 209 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 parents / legal guardians according to national law; - Written informed assent is available from the child/adolescent according to age and capacity of understanding; - They received the third vaccination with FSME-IMMUN 0.25 ml during the course of study 209; - Blood was drawn after their third vaccination during the course of study 209; - They showed an ELISA concentration > 126 VIE U/ml and / or a NT titer >= 10 after the third vaccination in study 209; - They or their parents / legal guardians agree to keep a Subject Diary. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: - received any TBE vaccination since their third vaccination with FSME-IMMUN 0.25 ml; - have a history of infection with or vaccination against other flaviviruses (Dengue fever, yellow fever and / or Japanese B-encephalitis virus) since their third vaccination with FSME-IMMUN 0.25 ml; - are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination with FSME-IMMUN 0.25 ml; - received a blood transfusion or immunoglobulins within 30 days of the first and second blood draw (as applicable); - have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages); - have participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies). Subjects will not be eligible for the booster vaccination if they: - do not meet the inclusion / exclusion criteria; - are not clinically healthy, (i.e. the physician would have reservations vaccinating with a TBE vaccine outside the scope of a clinical trial); - suffer 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; - have shown an allergic reaction to one of the components of the vaccine since their third vaccination in study 209; - have donated blood or plasma within 30 days to the booster vaccination; - if female of childbearing potential - are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination); - are simultaneously participating in another clinical trial including administration of an investigational product within six weeks prior to the booster vaccination until the end of the study. Subjects who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature >= 38.0°C, measured orally) at the scheduled time of vaccination, will not be vaccinated until their body temperature returns to normal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Seropositivity rate measured by ELISA and/or NT according to Adner et al., 2001 at each available time point after the third vaccination in study 209 and separately at each available time point after the booster vaccination in this study ;Secondary Objective: Seropositivity (ELISA) post blood draw ff 3rd vacc. and separately for each time point ff booster; Seropositivity (NT) post blood draw ff 3rd vacc.; Ab conc. post blood draw after 3rd vacc. and after booster (ELISA); Ab titers after each blood draw after 3rd vacc. and after booster (NT); Fold increase in Ab conc. after booster versus before booster (ELISA) separately for each time point when the booster is given; Fold increase in Ab titers after booster versus before the booster (NT) separately for each time point when the booster is given; Seropositivity (NT) post blood draw after the 3rd vacc. and separately at each time point after booster; Ab titers post blood draw after 3rd vacc. and separately at each time point after the booster (NT); Fold increase in Ab titers after booster versus before booster (NT) separately for each time point when booster is given; Fever rate; Local and systemic reactions. ;Primary end point(s): Seropositivity rate measured by ELISA and/or NT according to Adner et al., 2001, rate at each time point when blood is drawn after the third vaccination in study 209 and separately at each time point after the booster vaccination in this study. | — |
Countries
Austria, Germany
Outcome results
None listed