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

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.

Keywords

• inactivated split influenza vaccine (flu-m)
• adult population aged between 18 and 60
• safety
• reactogenicity
• immunogenicity
• randomized clinical trial