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.
Pöllabauer
Eva Maria
EM
Global R&D, Baxter BioScience, Industriestrasse 67, A-1220 Vienna, Austria.
Pavlova
Borislava G
BG
Löw-Baselli
Alexandra
A
Fritsch
Sandor
S
Prymula
Roman
R
Angermayr
Rudolf
R
Draxler
Wolfgang
W
Firth
Clair
C
Bosman
Jael
J
Valenta
Barbara
B
Harmacek
Peter
P
Maritsch
Friedrich
F
Barrett
P Noel
PN
Ehrlich
Hartmut J
HJ
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*
D000914:Antibodies, Viral; C464914:Encepur; C547297:FSME-IMMUN vaccine; D015164:Vaccines, Inactivated; D014765:Viral Vaccines