title: Clinical evaluation to determine the appropriate paediatric formulation of a tick-borne encephalitis vaccine.
abstract: 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.
authors.affiliation: Global R&D, Baxter BioScience, Vienna, Austria.
authors.forename: Eva Maria
authors.initials: EM
authors.lastname: Pöllabauer
authors.forename: Sandor
authors.initials: S
authors.lastname: Fritsch
authors.forename: Borislava G
authors.initials: BG
authors.lastname: Pavlova
authors.forename: Alexandra
authors.initials: A
authors.lastname: Löw-Baselli
authors.forename: Clair
authors.initials: C
authors.lastname: Firth
authors.forename: Manuela
authors.initials: M
authors.lastname: Koska
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: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D004304:Dosage Forms; D004306:Dose-Response Relationship, Immunologic; D004311:Double-Blind Method; D004669:Encephalitis Viruses, Tick-Borne / Q000276:immunology; D004675:Encephalitis, Tick-Borne / Q000517:prevention & control*; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007223:Infant; D010372:Pediatrics; D014765:Viral Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D004304:Dosage Forms; D007074:Immunoglobulin G; D014765:Viral Vaccines