Results of a clinical study of the influenza tetravalent inactivated subunit adjuvant vaccine Grippol Quadrivalent in children aged 6 months to 5 years (inclusive)

The article presents the results of a clinical investigation on the administration of the Grippol Quadrivalent vaccine (influenza tetravalent inactivated subunit adjuvant vaccine) in children from 6 months to 5 years old. The vaccine has demonstrated no less effectiveness in comparison with the Grippol plus vaccine (influenza trivalent inactivated polymer-subunit vaccine).comparable results were obtained for all evaluated indicators of immunological efficacy against matching strains of the influenza virus, while for additional strain B (Yamagata line) there was a statistically significant difference in the increase in the immune response in the Grippol Quadrivalent group. The results of the assessment of the reactogenicity and frequency of systemic adverse events indicated a favorable and comparable safety profile of the vaccines Grippol Quadrivalent and Grippol plus in children from 6 months to 5 years old. The data obtained allowed us to conclude that the immunological efficacy of the Grippol Quadrivalent vaccine is no less when compared to the Grippol plus vaccine, as well as a comparable safety and reactogenicity profile. According to the results of the clinical investigation, on 08/04/2023, the Ministry of Health of the Russian Federation amended the “Instructions for the medical use of the drug”: Grippol Quadrivalent is indicated for children from the age of 6 months.

1. Olson SM, Newhams MM, Halasa NB, et al. Vaccine Effectiveness Against Life-Threatening Influenza Illness in US Children. Clin Infect Dis. 2022;75(2):230–238. https://doi.org/10.1093/cid/ciab931

2. Wang X, Li Y, O’Brien KL, et al. Global burden of respiratory infections associated with seasonal influenza in children under 5 years in 2018: a systematic review and modelling study. Lancet Glob Health. 2020;8(4):e497–e510. https://doi.org/10.1016/S2214-109X(19)30545-5

3. Esposito S, Nauta J, Lapini G, et al. Efficacy and safety of a quadrivalent influenza vaccine in children aged 6-35 months: A global, multiseasonal, controlled, randomized Phase III study. Vaccine. 2022;40(18):2626–2634. https://doi.org/10.1016/j.vaccine.2022.02.088

4. Konshina OS, Sominina AA, Smorodintseva EA, et al. Population immunity to influenza virus A(H1N1)pdm09, A(H3N2) and B in the adult population of the Russian Federation long-term research results.russian Journal of Infection and Immunity = Infektsiya i immunitet. 2017;7(1):27–33. (In Russ). https://doi.org/10.15789/2220-7619-2017-1-27-33

5. Belshe RB. The need for quadrivalent vaccine against seasonal influenza. Vaccine. 2010;28(Suppl 4):D45–D53. https://doi.org/10.1016/j.vaccine.2010.08.028

6. Gorse GJ, Falsey AR, Ozol-Godfreyc A, et al. Safety and immunogenicity of a quadrivalent intradermal influenza vaccine in adults. Vaccine. 2015;33(9):1151–1159. https://doi.org/10.1016/j.vaccine.2015.01.025

7. Briko NI. 100 Years after the Spanish Flu Pandemic. The Evolution of the Influenza Virus and the Development of the Flu Vaccine. Epidemiology and Vaccinal Prevention. 2018;17(4):68–97. (In Russ). https://doi.org/10.31631/2073-3046-2018-17-4-68-97

8. Kharit SM, Lioznov DA, Ruleva AA, et al.comparative Assessment of Reactogenicity and Immunogenicity of Commercial Influenza Inactivated Vaccines: Polymer-Subunit Grippol plus, Subunit Influvac, Split Vaccine Waxigrip. Epidemiology and Vaccinal Prevention. 2017;16(2):24–30. (In Russ). https://doi.org/10.31631/2073-3046-2017-16-2-24-30

9. Chebykina TV. Proyavleniya epidemicheskogo protsessa grippa i ORVI sredi detskogo naseleniya v vozraste do dvukh let i lits 60 let i starshe. Sovershenstvovanie taktiki vaktsinoprofilaktiki grippa v dannykh gruppakh riska. [dissertation]. Perm; 2018. 28 p. (In Russ).

10. Mantel C, Chu SY, Hyde TB, et al. Seasonal influenza vaccination in middle-income countries: assessment of immunization practices in Belarus, Morocco, and Thailand. Vaccine. 2020;38(2):212–219. https://doi.org/10.1016/j.vaccine.2019.10.028

11. Demicheli V, Jefferson T, Ferroni E, et al. Vaccines for preventing influenza in healthy adults. Cochrane Database Syst Rev. 2018;2(2):CD001269. https://doi.org/10.1002/14651858.CD001269.pub6

12. Dijkstra F, Donker GA, Wilbrink B, et al. Long time trends in influenza-like illness and associated determinants in the Netherlands. Epidem Infect. 2009;137(4):473–479. https://doi.org/10.1017/S095026880800126X

13. WHO. Programmes/Influenza WHO recommendations on the composition of influenza virus vaccines. World Health Organization: Official website. Available online: https://www.who.int/news/item/25-02-2022-recommendations-announced-for-influenza-vaccinecomposition-for-the-2022-2023-northern-hemisphere-influenzaseason. Accessed on May 05, 2022.

14. Grohskopf LA, Alyanak E, Ferdinands JM, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2021-22 Influenza Season. MMWR Recomm Rep. 2021;70(5):1–28. https://doi.org/10.15585/mmwr.rr7005a1

15. Chuchalin AG, Avdeev SN, Chernyaev AL, et al. Federal guidelines on diagnosis and management of severe influenza. Pulmonologiya. 2014;(5):11–19. (In Russ). https://doi.org/10.18093/0869-0189-2014-0-5-11-19

16. State register of medicines. (In Russ). Доступно по: https://grls. rosminzdrav.ru. Ссылка активна на 01.12.2023.

17. Strategy for the development of immunoprevention of infectious diseases for the period until 2035, approved by Order of the Government of the Russian Federation of September 18, 2020 No. 2390-р. (In Russ).] Доступно по: http://static.government.ru/media/files/Zz7brckXMkAQTZHTA6ixAxlY4lhYBEeM.pdf. Ссылка активна на 01.12.2023.

18. Kompier R, Neels P, Beyer W, et al. Analysis of the safety and immunogenicity profile of an azoximer bromide polymer-adjuvanted subunit influenza vaccine. F1000Res. 2022;11:259. https://doi.org/10.12688/f1000research.75869.2

19. Otsenka immunogennosti, reaktogennosti i bezopasnosti vaktsiny Grippol® Kvadrivalent u detei v vozraste ot 6 mesyatsev do 5 let: RCT No. 500 (08/19/2022) (In Russ).] Доступно по: https://grls.rosminzdrav.ru/CIPermissionMini.aspx?CIStatementGUID=e733b393-13f4-4df4-810d-207e90d0df0f&CIPermGUID=119b1d06-f3b1-43f6-96d9-75e0a3d93221. Ссылка активна на 01.12.2023.

20. Grippol Quadrivalent Vaccine quadrivalent inactivated subunit adjuvant. Registration certificate No. ЛП-004951 dated July 23, 2018. (In Russ).] Доступно по: https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=aaad7988-7890-4311-aff9-8bea62268f88. Ссылка активна на 01.12.2023.