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The need for highly effective tick-borne encephalitis (TBE) vaccines has increased globally due to a variety of factors including climate, social, economic and demographic changes, which are thought to have promoted the expansion of the endemic region of TBE viruses. The first TBE vaccine, FSME-IMMUN Inject, was introduced in the 1970s and has been continually improved since then to enhance both its safety and immunogenicity. The current formulation was established in 2001 and is marketed as FSME-IMMUN. This review summarizes findings of the clinical development programme since 2001 regarding determination of the optimal dose, conventional and rapid vaccination schedules, vaccination in adults, the elderly and special patient populations, safety, immunogenicity, and immunopersistence in adults and children, comparison of FSME-IMMUN with another commercially available TBE vaccine as well as post-marketing vaccination outcome. This successful research programme demonstrated the strong immunogenicity and continued safety of the FSME-IMMUN vaccine, which is further confirmed by the performance reported under field conditions.