The results of an Open, Randomized Comparative Clinical Study to Assess the Reactogenicity, Safety and Immunogenicity of the Vaccine EntseVir in Children Aged 3 to 17 Years

Abstract

In 2011 - 2012 years in the Institute of childhood infections followed by an open comparative randomized study of tick-borne encephalitis vaccine EntseVir («Microgen») at a dose of 0.25 ml of the two schemes, planned and emergency in children aged 3 - 17 years. As a reference drug used vaccine FSME-Immun junior production (Baxter, AG, Austria). The results of clinical studies have shown that Entsevir at a dose of 0.25 ml has a good safety profile, low reactogenicity. Mostly recorded transient local reactions such as pain at the injection site weak degree. Severe reactions and post-vaccination complications were absent. EntseVir has no immunosuppressive, immunopathological action, highly immunogenic and can be recommended for mass prophylaxis tick-borne encephalitis in children 3 - 17 years on two schemes of vaccination (planned with an interval of 60 days and emergency with an interval of 14 days).