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

I. V. Feldblyum; Фельдблюм И. В.; K. A. Subbotina; Субботина К. А.; S. D. Novgorodova; Новгородова С. Д.; G. M. Ignatev; Игнатьев Г. М.; M. Kh. Alyeva; Алыева М. Х.; M. K. Erofeeva; Ерофеева М. К.; V. G. Orlovsky; Орловский В. Г.; I. A. Leneva; Ленева И. А.; S. Ya. Melnikov; Мельников С. Я.; E. V. Kazakova; Казакова Е. В.; E. P. Nacharova; Начарова Е. П.; V. P. Trukhin; Трухин В. П.

doi:10.36233/0372-9311-2018-5-31-37

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

Authors: Feldblyum I.V.¹, Subbotina K.A.¹, Novgorodova S.D.¹, Ignatev G.M.², Alyeva M.K.¹, Erofeeva M.K.³, Orlovsky V.G.⁴, Leneva I.A.⁵, Melnikov S.Y.⁶, Kazakova E.V.⁶, Nacharova E.P.⁶, Trukhin V.P.⁶
Affiliations:
1. Vagner Perm State Medical University
2. St. Petersburg Research Institute of Vaccines and Sera and the Bacterial Preparations Factory, Chumakov Federal Scientific Centre for Research and Development of Immunobiological Products
3. Research Institute of Influenza, St. Petersburg
4. Centre for Infections Ltd
5. Mechnikov Research Institute of Vaccines and Sera
6. St. Petersburg Research Institute of Vaccines and Sera and the Bacterial Preparations Factory
Issue: Vol 95, No 5 (2018)
Pages: 31-37
Section: ORIGINAL RESEARCHES
Submitted: 10.04.2019
Published: 28.10.2018
URL: https://microbiol.crie.ru/jour/article/view/305
DOI: https://doi.org/10.36233/0372-9311-2018-5-31-37
ID: 305

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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.

Keywords

inactivated split influenza vaccine (Flu-M), adult population aged between 18 and 60, safety, reactogenicity, immunogenicity, randomized clinical trial

References

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

Full Text

Abstract

Keywords

About the authors

References

Supplementary files

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