Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated Acco… (NCT00460486) | Clinical Trial Compass
CompletedPhase 3
Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule
Poland330 participantsStarted 2006-09
Plain-language summary
The objective of this study is to investigate the immunogenicity and safety of FSME-IMMUN 0.5 ml in two age strata (stratum A: 16 to 49 years, stratum B: \> 50 years), with the first and second vaccinations being administered according to a rapid immunization schedule (12 ± 2 days apart). The third vaccination will be administered approximately 6 months after the first dose.
Who can participate
Age range16 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 (assent if the subjects is under 18 years of age);
* Provide the written informed consent of their parents / legal guardian (if the subject is under 18 years of age);
* Are aged \>= 16 years (from the 16th birthday) at screening;
* Are clinically healthy, (i.e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial);
* Have a negative pregnancy test result at the first medical examination (if female and capable of bearing children);
* Agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children);
* Agree to keep a Subject Diary.
Exclusion Criteria:
Subjects will be excluded from participation in this study if they:
* Have a history of any previous tick-borne encephalitis (TBE) vaccination;
* Have a history of TBE infection;
* Have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis);
* Have a history of allergic reactions, in particular to one of the components of the vaccine;
* 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 a known or suspected p…
What they're measuring
1
Immunogenicity: Seropositivity rate as determined by Enzyme-Linked Immunosorbent Assay (ELISA) and Neutralization test (NT) at Days 7, 14 and 21 after the second vaccination, in stratum A and B separately, and in the two age strata combined.