Safety and Tolerability of Split-Virion Influeza Vaccine in Spanish Children

Abstract

Background: the difficulties which exist in order to value correctly the morbimortality caused by influenza during the childhood and the limitations of the proper vaccine make that the use of this vaccination is still limitated in this phase. The objective of the present study is to value the adverse reactions associated to the influenza immunization in children. Methods: prospective study, carried out in the campaigns 92/ 93, 93/ 94 97/ 98 on 105 children of Navalcarnero with split-virion influenza vaccine with vaccunal strains recommended by the OMS. All the doses are administered by a nurse who also carries out the postimmunization-controls after 72 hours. The adverse reactions are valued, like the zone of injection, sex, age, the previous vaccination and the collection of data by telephone or in consultation. Results: of global form (318 doses), on a local level appears a reaction of 10,7%, in form of erythema (8,5%), induration (7,9%) and pain (only 97/98, 13,9%) and on a systemic level appears a reaction of 11,9%, in form of rhinorrhea (3,1%), general discomfort (2,5%), fever (2,5%), muscular pains (1,6%) and cough (1,6%). In a 89,5% the systemic effects disappear during the first 48 hours. In no case medical consultation was precised. Conclusions: the vaccine is safe. The adverse reactions that may appear are scarce, slight and well tolerated. There do not exist significant differences in terms of age, sex, the previous vaccination or the collection of the results by telephone or in consultation. The gluteus presents greater local reactogenicity that the deltoidal zone.