Safety, immunogenicity and tolerability of a new pediatric tick-borne encephalitis (TBE) vaccine, free of protein-derived stabilizer.
Vaccine
; 21(25-26): 3584-92, 2003 Sep 08.
Article
en En
| MEDLINE
| ID: mdl-12922086
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.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Vacunas Virales
/
Encefalitis Transmitida por Garrapatas
/
Virus de la Encefalitis Transmitidos por Garrapatas
Tipo de estudio:
Clinical_trials
Límite:
Child
/
Child, preschool
/
Female
/
Humans
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Infant
/
Male
Idioma:
En
Revista:
Vaccine
Año:
2003
Tipo del documento:
Article
País de afiliación:
Alemania
Pais de publicación:
Países Bajos