title: Comparison of immunogenicity and safety between two paediatric TBE vaccines.
abstract: 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.
authors.affiliation: Global R&D, Baxter BioScience, Industriestrasse 67, A-1220 Vienna, Austria.
authors.forename: Eva Maria
authors.initials: EM
authors.lastname: Pöllabauer
authors.forename: Borislava G
authors.initials: BG
authors.lastname: Pavlova
authors.forename: Alexandra
authors.initials: A
authors.lastname: Löw-Baselli
authors.forename: Sandor
authors.initials: S
authors.lastname: Fritsch
authors.forename: Roman
authors.initials: R
authors.lastname: Prymula
authors.forename: Rudolf
authors.initials: R
authors.lastname: Angermayr
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Draxler
authors.forename: Clair
authors.initials: C
authors.lastname: Firth
authors.forename: Jael
authors.initials: J
authors.lastname: Bosman
authors.forename: Barbara
authors.initials: B
authors.lastname: Valenta
authors.forename: Peter
authors.initials: P
authors.lastname: Harmacek
authors.forename: Friedrich
authors.initials: F
authors.lastname: Maritsch
authors.forename: P Noel
authors.initials: PN
authors.lastname: Barrett
authors.forename: Hartmut J
authors.initials: HJ
authors.lastname: Ehrlich
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D004669:Encephalitis Viruses, Tick-Borne / Q000276:immunology; D004675:Encephalitis, Tick-Borne / Q000276:immunology / Q000517:prevention & control*; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007223:Infant; D007273:Injections, Intramuscular; D008297:Male; D016037:Single-Blind Method; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology; D014765:Viral Vaccines / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; C464914:Encepur; C547297:FSME-IMMUN vaccine; D015164:Vaccines, Inactivated; D014765:Viral Vaccines