Tick-borne Encephalitis (TBE)
Conditions
Brief summary
The purpose of this study is to evaluate TBE antibody persistence from 7 to 10 years after the first booster TBE vaccination with FSME-IMMUN 0.5ml.
Interventions
BIOLOGICALFSME-IMMUN 0.5 ml
Solution/suspension for injection (intramuscular injection into the deltoid muscle of the right or left upper arm). Dosage frequency of booster vaccination: dependent on serum TBE antibodies.
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects who participated in the first and second precursor studies 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 first precursor study and did not receive a second booster vaccination in the second precursor study * blood was drawn after their first booster vaccination in the first precursor study
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 since their first booster vaccination with FSME-IMMUN 0.5ml * have a known or suspected problem with drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seropositivity rate measured by neutralization test (NT) 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study | 118 months |
Secondary
| Measure | Time frame |
|---|---|
| Seropositivity rate measured by ELISA test 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study | 118 months |
| Antibody titers 82, 94, 106 and 118 months after the first booster TBE vaccination administered in the first precursor study and after the booster vaccination in this study measured by ELISA and by NT | 118 months |
| Fold increase in antibody concentration after the booster vaccination administered as compared to before the booster vaccination in this study measured by ELISA and by NT | 118 months |
Countries
Poland
Outcome results
None listed