REACTOGENICITY, SAFETY AND IMMUNOGENICITY OF DOMESTIC FLU-M INACTIVATED SPLIT INFLUENZA VACCINE FOR THE IMMUNIZATION OF ADULTS AGED BETWEEN 18 AND 60

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Abstract

Aim. The research was aimed at evaluating the reactogenicity, safety and immunogenicity of Flu-M inactivated split influenza vaccine. Materials and methods. The reactogenicity, safety and immunogenicity of the drug were studied in the course of a multicenter, double blind, comparative, randomized clinical trial of immunized volunteers aged between 18 and 60 (comparator - Vaxigrip inactivated split vaccine for influenza prevention). Results. Domestic Flu-M inactivated split influenza vaccine manufactured by St. Petersburg Research Institute of Vaccines and Sera features favorable tolerability, high safety profile and adequate immunogenicity which is consistent with that of Vaxigrip influenza vaccine. Conclusion. Flu-M inactivated split influenza vaccine manufactured by St. Petersburg Research Institute of Vaccines and Sera can be recommended for authorization in the Russian Federation for the purpose of specific prophylaxis of influenza for adults aged between 18 and 60.

About the authors

I. V. Feldblyum

Vagner Perm State Medical University

Author for correspondence.
Email: noemail@neicon.ru
Russian Federation

K. A. Subbotina

Vagner Perm State Medical University

Email: noemail@neicon.ru
Russian Federation

S. D. Novgorodova

Vagner Perm State Medical University

Email: noemail@neicon.ru
Russian Federation

G. M. Ignatev

St. Petersburg Research Institute of Vaccines and Sera and the Bacterial Preparations Factory, Chumakov Federal Scientific Centre for Research and Development of Immunobiological Products

Email: noemail@neicon.ru
Russian Federation

M. Kh. Alyeva

Vagner Perm State Medical University

Email: noemail@neicon.ru
Russian Federation

M. K. Erofeeva

Research Institute of Influenza, St. Petersburg

Email: noemail@neicon.ru
Russian Federation

V. G. Orlovsky

Centre for Infections Ltd

Email: noemail@neicon.ru
Russian Federation

I. A. Leneva

Mechnikov Research Institute of Vaccines and Sera

Email: noemail@neicon.ru
Russian Federation

S. Ya. Melnikov

St. Petersburg Research Institute of Vaccines and Sera and the Bacterial Preparations Factory

Email: noemail@neicon.ru
Russian Federation

E. V. Kazakova

St. Petersburg Research Institute of Vaccines and Sera and the Bacterial Preparations Factory

Email: noemail@neicon.ru
Russian Federation

E. P. Nacharova

St. Petersburg Research Institute of Vaccines and Sera and the Bacterial Preparations Factory

Email: noemail@neicon.ru
Russian Federation

V. P. Trukhin

St. Petersburg Research Institute of Vaccines and Sera and the Bacterial Preparations Factory

Email: noemail@neicon.ru
Russian Federation

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Copyright (c) 2018 Feldblyum I.V., Subbotina K.A., Novgorodova S.D., Ignatev G.M., Alyeva M.K., Erofeeva M.K., Orlovsky V.G., Leneva I.A., Melnikov S.Y., Kazakova E.V., Nacharova E.P., Trukhin V.P.

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