The article presents the results of an open comparative randomized clinical study on the assessment of the reactogenicity, safety and immunogenicity of the domestic vaccine "EntseVir®" with reduced antigenic load in immunization of children aged 3 to 17 years on the schedule for 0-60 days. The vaccine is characterized by the low reactogenicity, high safety profile and immunogenicity. On main indices, it is not inferior to foreign vaccine «FSME-Immun Inject / Junior».

The article presents the results of the open comparative randomized clinical study performed in children aged 3 to 17 years which were immunized with the Russian vaccine «EnceVir»® possessing the reduced antigenic load accordingly to emergency vaccination protocol. The aim of the study was to assess reactogenicity, safety and immunogenicity of the vaccine. The vaccine is characterized by a low reactogenicity profile, the high profile of safety, adequate immunogenicity, and it is not yielding to foreign vaccine «FSME-Immun Inject / Junior»

Пермский государственный медицинский университет им. Е.А.Вагнера; 2 НПО «Микроген», Москва; 3 Детская городская больница № 10, Екатеринбург; 4 НИИ вирусных инфекций, Екатеринбург Цель. Оценка реактогенности, безопасности и иммуногенности новой отечественной комбинированной вакцины АКДС-ГепВ+Hib. Материалы и методы. Оценка реактогенности, безопасности и иммуногенности препарата исследованы в многоцентровом простом слепом сравнительном рандомизированном клиническом исследовании при иммунизации детей 6 месяцев (препарат сравнения -вакцина АКДС-ГепВ в сочетании с вакциной Хиберикс ® ). Результаты. Отечественная комбинированная вакцина АКДС-ГепВ+Hib характеризуется хорошей переносимостью, высоким профилем безопасности и выраженной иммуногенностью. По показателям серопротекции, сероконверсии и средней геометрической титров антител сопоставима с используемыми в России вакцинами АКДС-ГепВ и Хиберикс ® . Заключение. Вакцина АКДС-ГепВ+Hib может быть рекомендована для регистрации на территории Российской Федерации для профилактики коклюша, дифтерии, столбняка, гепатита В и Hib-инфекции.

Aim. Study safety, reactogenicity and immunologic effectiveness of a national combined vaccine against diphtheria, pertussis (acellular component), tetanus, hepatitis B and Hib-infection during immunization of volunteers aged 18 - 60 years. Materials and methods. The study was carried out in accordance with ethical standards and requirements, regulated by Helsinki declaration and Good clinical practice (ICHGCP). In a simple non-randomized clinical trial 20 adult volunteers took part, the mean age of those was 46.9 years. Results. Registered post-vaccination reactions (both local and systemic) were mild and of moderate degree of severity, stopped independently after 2 - 3 days without administration of drug treatment. Postvaccinal complications were not noted. Parameters of general and biochemical analysis of blood, urine, IgE content in dynamics of immunization were within normal limits. A single administration of aAPDT-HepB+Hib to individuals aged 18 - 60 years resulted in development of antibodies against all the components of the preparation. Seroconversion factor fluctuated from 6.9 to 53.5. Conclusion. The results obtained allow to recommend the vaccine for evaluation of its safety, reactogenicity, immunologic and prophylaxis effectiveness in randomized clinical observation trials in children.