11. národní očkovací den, 2005
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H. J. Ehrlich, E. M. Poellabauer, A. Loew-Baselli, S. Fritsch, I. Mai, P. Harmacek, B. G. Pavlova, U. Behre, R. Konior for the FSME-IMMUN 0.25ml Junior pediatric study group 1Global Clinical R&D, Baxter, BioSience, Pediatric Practice Kehl, Germany, Dept. of Neuroinfectious Diseases, The John Paul II Hospital, Krakow, Poland 

   Two dose finding studies and one safety study with FSME-IMMUN 0.25ml Junior were conducted in children and adolescents aged 1–6 years (n= 639), 6–16 years (n= 639) and 1-15 years (n=2419), respectively. The dose finding studies investigated the safety and immunogenicity of three vaccinations with 0.3µg, 0.6µg or 1.2µg TBE- antigen. The first and second vaccinations were given 21–35 days apart; the third vaccination was given six months after the first vaccination. In both age groups, the 1.2µg antigen amount was identified as the optimal dose. The 1.2µg dose induced highseroconversion rates (1-6 year olds: 100%; 6–16 year olds: 98.5%) after the second vaccination an d seroconversion rates of 100% in both age groups after the third vaccination, as determined by ELISA. Local and systemic reactions after the first and second vaccinations occurred at a low frequency, with no dose dependency observed. Fever after the first and second vaccinations with the 1.2µg dose occurred in 15.9% and 13.4% respectively in children aged 1–6 years (measured rectally), and in 3.4% and 3.9% respectively in children aged 6–16 years (measured orally). Local reactions, systemic reactions and fever after the third vaccination occurred in both age groups at a low rate and showed no dose dependence.
    In the safety study, the analysis of immunogenicity in a subgroup showed a seroconversion rate of 96% (as determined by ELISA) after two vaccinations with the 1.2µg dose. Local and systemic reactions after both vaccinations occurred at a low frequency and were mainly mild. The probability of fever occurrence after the first and second vaccinations was low (9.7% and 2.3%, respectively). The majority of these fever cases were mild, and most subsided within 24 hours. No vaccine-related fever over 40.0°C was observed. In all three studies, fever was age dependent, with the highest fever rate occurring among children aged 1- 2 years and lower rates observed among the children aged 3-15 years. No vaccine-related serious adverse events occurred during the studies. 
   These results demonstrate that, at the optimal dose of 1.2µg TBE- antigen, FSME-IMMUN 0.25ml Junior is safe and highly immunogenic in a large population of children and adolescents aged 1–16 years. Pharmacovigilance data confirm the safety profile of the vaccine.