
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
Author(s) -
С. М. Харит,
А. А. Рулева,
И. В. Фридман,
Е. П. Начарова,
Л. А. Алексеева,
Г. А. Васильева,
A. A. Vilnic,
М. В. Иванова
Publication year - 2015
Publication title -
èpidemiologiâ i vakcinoprofilaktika
Language(s) - English
Resource type - Journals
eISSN - 2619-0494
pISSN - 2073-3046
DOI - 10.31631/2073-3046-2015-14-2-66-72
Subject(s) - reactogenicity , medicine , immunogenicity , vaccination , pediatrics , encephalitis , tick borne encephalitis , immunology , antigen , virus
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).