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Two dose-finding studies and one open label safety study with a paediatric FSME-IMMUN formulation were conducted in children and adolescents aged 1-15 years (N=3697). The 1.2 microg antigen dose was identified as the optimal dose, inducing high seroconversion rates following the primary vaccination series. Adolescents (aged 12-15 years) vaccinated with the optimal paediatric dose (1.2 microg) attained similarly high seroprotective rates to adults (aged 16-35 years) vaccinated with the 2.4 microg formulation of FSME-IMMUN. We concluded that the FSME-IMMUN paediatric vaccine formulation is safe and highly immunogenic, not only for children <12 years, but also for adolescents <16 years.