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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
330
Centrum Badan Farmakologii Klinicznej monipol
Krakow, Poland
Niepubliczny ZOZ "Atarax" s.c.
Olsztyn, Poland
Niepubliczny ZOZ "VITA"
Olsztyn, Poland
"PANTAMED" Sp. z o.o.
Olsztyn, Poland
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.
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