In this Study the Seropersistence of Tick Borne Encephalitis (TBE) Virus Antibodies after the First Booster and the Response to a Second Booster Vaccination with FSME-IMMUN 0.5ml in Adults will be investigated. Tick-borne encephalitis (TBE) virus is a member of the family Flaviviridae, which comprises approximately 70 different viruses that cause many serious diseases in a wide variety of vertebrates, including humans. MedDRA version: 9.1 Level: LLT Classification code 10043847 Term: Tick-born
Conditions
Interventions
Trade Name: FSME-IMMUN 0.5 ml
Pharmaceutical Form: Suspension for injection
Sponsors
Baxter AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who participated in the preceding Study will be eligible for participation in this study if: · they understand the nature of the study, agree to its provisions and provide written informed consent; · they received the first booster vaccination with FSME-IMMUN 0.5ml during the course of study 223; · blood was drawn after their first booster vaccination in Study 223. Are the trial subjects under 18? no 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) yes 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 first booster vaccination with FSME-IMMUN 0.5ml; · have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) since their first booster vaccination with FSME-IMMUN 0.5ml; · are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their first booster vaccination with FSME-IMMUN 0.5ml; · have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: TBE antibody persistence 24, 34, 46 and 58 months (as applicable) after the first booster TBE vaccination with FSME-IMMUN 0.5ml by means of ELISA (IMMUNOZYM FSME IgG) and neutralization test (NT); TBE antibody response to a second booster vaccination with FSME-IMMUN 0.5ml in the present study, by means of ELISA and NT. ;Secondary Objective: Safety of FSME-IMMUN 0.5ml after the second booster vaccination in the present study;Primary end point(s): Seropositivity rate measured by ELISA and/or NT 24, 34, 46 and 58 months after the first booster TBE vaccination in Study 223 and after the booster vaccination in this study. | — |
Countries
Poland
Outcome results
None listed