Clinical evaluation to determine the appropriate paediatric formulation of a tick-borne encephalitis vaccine.
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.
Pöllabauer
Eva Maria
EM
Global R&D, Baxter BioScience, Vienna, Austria.
Fritsch
Sandor
S
Pavlova
Borislava G
BG
Löw-Baselli
Alexandra
A
Firth
Clair
C
Koska
Manuela
M
Maritsch
Friedrich
F
Barrett
P Noel
PN
Ehrlich
Hartmut J
HJ
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
D000914:Antibodies, Viral; D004304:Dosage Forms; D007074:Immunoglobulin G; D014765:Viral Vaccines