TBE Seropersistence up to 10 Years After First Booster in Adults (NCT01582698) | Clinical Trial Compass
CompletedPhase 4
TBE Seropersistence up to 10 Years After First Booster in Adults
Poland243 participantsStarted 2012-04
Plain-language 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.
Who can participate
Age range25 Years
SexALL
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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
What they're measuring
1
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