Investigation of the Seropersistence of TBE Antibodies and the Booster Response to FSME-IMMUN 0.5… (NCT00161785) | Clinical Trial Compass
CompletedPhase 4
Investigation of the Seropersistence of TBE Antibodies and the Booster Response to FSME-IMMUN 0.5 ml in Adults Aged 18 - 67 Years
Poland340 participantsStarted 2004-06
Plain-language summary
The purpose of this study is to assess:
* TBE antibody persistence 2 and 3 years after the third TBE vaccination with FSME-IMMUN 0.5ml by means of ELISA and neutralization test (NT).
* TBE antibody response to a booster vaccination with FSME-IMMUN 0.5ml, by means of ELISA and NT.
Who can participate
Age range18 Years – 67 Years
SexALL
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Inclusion Criteria:
Male and female subjects 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 third vaccination with FSME-IMMUN 0.5ml during the course of Baxter Study 213;
* blood was drawn before and after their third vaccination during the course of Baxter Study 213;
* they showed an ELISA-concentration \> 126 VIE U/ml and / or a NT-titer \>= 1:10 after the third vaccination in Baxter Study 213;
* they agree to keep a Subject Diary.
Exclusion Criteria:
Subjects will be excluded from participation in this study if they:
* received any TBE vaccination since their third vaccination with FSME-IMMUN 0.5ml;
* received a vaccination against yellow fever and / or Japanese B-encephalitis since their third 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 third 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);
* have received a blood transfusion or immunoglobulins within one month to the first and second blood draw;
* 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 booster vaccination if:
* they do not meet the inclusion/exclusion …