Safety, immunogenicity and tolerability of a new pediatric tick-borne encephalitis (TBE) vaccine, free of protein-derived stabilizer.
A total of 3,559 children aged 1-11 years were enrolled in two clinical studies to evaluate immunogenicity and safety of a new pediatric tick-borne encephalitis (TBE) vaccine, free of protein-derived stabilizer. Immunogenicity was evaluated in the rapid immunization schedule (Days 0, 7, and 21) from sera collected at baseline and on Day 42 post-immunization by in vitro TBE virus neutralization test. All subjects analyzed achieved levels of TBE antibodies to fulfil the definition of seroconversion or a four-fold increase in antibody titres from baseline. The frequency of solicited post-immunization reactions ranged from 1 to 32% for reported local reactions and from 1 to 14% for systemic reactions. Overall, this can be regarded as expected for an inactivated, aluminium-adjuvanted, TBE vaccine. There was no indication for any new safety issues. An acceptably low number of febrile reactions above 38 degrees C with the highest frequency after first immunization (i.e. 15% and 5% in children aged 1-2 and 3-11 years, respectively), mainly below 39 degrees C, was reported. The results of both studies clearly show that TBE vaccination with this new TBE vaccine formulation can be achieved with a high degree of safety in children from 1 to 11 years of age.
Zent
O
O
Chiron Vaccines, Marburg, Germany. olaf_zent@chiron-behring.com
Banzhoff
A
A
Hilbert
A K
AK
Meriste
S
S
Słuzewski
W
W
Wittermann
Ch
Ch
D000914:Antibodies, Viral / Q000032:analysis / Q000096:biosynthesis; D002626:Chemistry, Pharmaceutical; D002648:Child; D002675:Child, Preschool; D004669:Encephalitis Viruses, Tick-Borne / Q000276:immunology*; D004675:Encephalitis, Tick-Borne / Q000276:immunology / Q000517:prevention & control*; D005079:Excipients; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D016037:Single-Blind Method; D014765:Viral Vaccines / Q000009:adverse effects / Q000737:chemistry / Q000276:immunology*
D000914:Antibodies, Viral; D005079:Excipients; D014765:Viral Vaccines