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Results of Clinical Trials of the First Russian 4-valent Flu Vaccine

Abstract

Ways for vaccines improvment are described. WHO criteria and domestic requirements for influenza vaccines quality are presented. The multicenter, double-blind, randomized trial in parallel groups of the first Russian quadrivalent vaccine is described in details. Multicenter study for assessment of vaccine safety, reactogenicity and immunogenicity was performed in 612 volunteers aged 18-60 years in the epidemic season 2016-2017.. In the study conducted , it was demonstrated that the first Russian quadrivalent influenza vaccine has a high tolerability and safety profile and meets the criteria for the immunogenicity of inactivated influenza vaccines.

About the Author

D. A. Lioznov
Research Institute of Influenza, St. Petersburg
Russian Federation

Dmitry A. Lioznov – Dr. Sci. (Med.), associate professor, deputy director for scientific work of Research Institute of Influenza, head of the department of infectious diseases and epidemiology of the Pavlov First Saint Petersburg State Medical University

 



References

1. Cunningham AL, Garcon N, Leo O, Friedland LR, Strugnell R, Laupeze B et al. Vaccine development: From concept to early clinical testing. Vaccine 2016; 34: 6655–6664

2. World Health Organization. WHO Preferred Product Characteristics (PPCs). World Health Organization (2017). Доступно на: http://apps.who.int/iris/bitstream/handle/10665/258767/9789241512466-eng.pdf;jsessionid=8F408EA0666E497D66B6CE7C1D06FE49?sequence=1

3. WHO, 2017. Immunization, Vaccines and Biologicals. Доступно на: http://www.who.int/immunization/research/meetings_workshops/webinar_ppc_next_gen_influenza_ vaccines/.

4. Ortiz JR. WHO Initiative for Vaccine Research WHO efforts to promote next-generation influenza vaccines, with particular focus on lowand middle-income countries. 2016. Доступно на: http://www.who.int/immunization/research/meetings_workshops/Justin_Ortiz_Chicago_August_2016.pdf?ua=1

5. http://www.who.int/immunization_standards/vaccine_quality/ru/

6. ФС.3.3.1.0028.15 Вакцина гриппозная инактивированная, Российская Фармакопея XIII: Доступно на: http://pharmacopoeia.ru/fs-3-3-1-0028-15-vaktsina-grippoznayainaktivirovannaya/.

7. Pasquale ADi, Preiss S, Tavares Da Silva F, Garcon N.Vaccine Adjuvants: from 1920 to 2015 and Beyond. Vaccines 2015; 3: 320–343; doi:10.3390/vaccines3020320.

8. www.euro.who.int/__data/assets/pdf_file/0010/236755/Influenza-Vaccine-rates-information-sheet-Rus.pdf?ua=1

9. http://www.who.int/influenza/vaccines/virus/recommendations/2017_18_north/en/

10. http://www.influenza.spb.ru/system/epidemic_situation/laboratory_diagnostics/?year=2018&week=25

11. Ray R, Dos Santos G, Buck PO, Claeys C, Matias G, Innis BL et al. A review of the value of quadrivalent influenza vaccines and their potential contribution to influenza control. Hum Vaccin Immunother.2017; 13 (7): 1640–1652. doi: 10.1080/21645515.2017.1313375.


Review

For citations:


Lioznov D.A. Results of Clinical Trials of the First Russian 4-valent Flu Vaccine. Epidemiology and Vaccinal Prevention. 2018;17(4):84-90. (In Russ.)

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ISSN 2073-3046 (Print)
ISSN 2619-0494 (Online)