Comparison of immunogenicity and safety between two paediatric TBE vaccines

TBE vaccination strategies capable of inducing strong paediatric immunogenicity and acceptable reactogenicity are still under evaluation. This single-blind, multi-center, randomized, controlled, phase III clinical study compared the immunogenicity and safety of the two paediatric TBE vaccines available in Europe (FSME-IMMUN® Junior and Encepur® Children) following administration of two doses of either vaccine in 303 children aged 1–11 years. Regardless of immunological test or viral antigen used, immunological responses were consistently higher in children vaccinated with FSME-IMMUN® Junior than those vaccinated with Encepur® Children. FSME-IMMUN® Junior is also non-inferior to Encepur® Children, with respect to NT seropositivity rates (p < 0.0001). Systemic reaction rates were low and similar between the vaccines. However, among children aged 7–11 years, local reactions were significantly higher after the first (p < 0.01) and second (p < 0.001) vaccination with Encepur® Children than with FSME-IMMUN® Junior, affecting half the children in the former group: 22.4% and 10.2% with FSME-IMMUN® Junior vs. 49.0% and 51.0% for Encepur® Children.