The blood samples were tested for TBE IgG antibodies by a commercially available ELISA (Enzygnost® Anti-FSME-Virus, Dade Behring, Germany). The threshold was set to 25 U/ml for putative seroprotection. All TBE antibody concentrations below 10 U/ml were set to 9.99 for statistical analysis.
selleck The data were analyzed by descriptive statistical methods. Mean ± SD or median ± quantiles were calculated as appropriate. Point estimates and 95% confidence intervals (CIs) were calculated for putative seroprotection rates. Geometric mean concentrations (GMC) with 95% CI and reverse cumulative distribution (RCD) plots were generated. Due to the extensive safety record of FSME-IMMUN vaccines [9] and [13] and the observational design of the study, no active safety measurements were performed. However, investigators were instructed to document and report any adverse reaction they become aware of during the conduct of the study. Safety analysis was limited to calculating the incidence of reported adverse reactions. The study was designed and funded by Baxter. Baxter employees RS, AR and BU
were responsible for study design, data collection, data analysis, data interpretation, and writing of the manuscript. Baxter independent Forskolin order co-authors UM, UH and RK served as the scientific advisory committee and were fully involved in the design of the study, data interpretation, and writing of the manuscript. UM was the responsible statistician and conducted the data management and analysis. The submission for publication was jointly decided by all authors. The corresponding author had full access to all data of the study. All study data were available to all authors on request. A total number of 2915 subjects were enrolled in 459 pediatric and general medical practices throughout Germany whereof 1240 (42.5%; 1115 adults and 125 children) fulfilled the criteria
for inclusion in this analysis. Demographic attributes and their distribution in subgroups by number of previous vaccinations and time interval since the last vaccination others are shown for adults in Table 2a and Table 2b. Adult study population: The median age was 34 years in young adults (16–50 years) and 61 years in the elderly (≥50 years). The median weight was 82.0 kg in males and 65.4 kg in females. As shown in Table 2b, 50% of the young adults presented with a minimum time interval between the last vaccination and the catch-up vaccination of 4.9–7.1 years, depending in the number of previous vaccinations, and 25% had an interval of at least 8.5–9.0 years. The respective figures for the elderly are 4.6–6.0 years (50%) and 7.3–8.8 years (25%). The maximum intervals ranged from 16.5–22.3 (young adults) and 17.4–23.0 years (elderly).
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