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 Grip...

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Main Authors: Viktor V. Romanenko, Leyla S. Namazova-Baranova, Alina A. Kotova, Kamilla E. Efendieva, Anna A. Ruleva, Ekaterina A. Khait, Olga A. Perminova, Tatiana E. Pak, Svetlana G. Lazareva, Liubov V. Aleshina, Dmitriy A. Suprun, Anna N. Galustyan, Olga A. Rychkova, Tatiana A. Romanova, Alfia I. Aminova, Galina V. Dulova
Format: Article
Language:Russian
Published: Union of pediatricians of Russia 2024-07-01
Series:Педиатрическая фармакология
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Online Access:https://www.pedpharma.ru/jour/article/view/2433
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author Viktor V. Romanenko
Leyla S. Namazova-Baranova
Alina A. Kotova
Kamilla E. Efendieva
Anna A. Ruleva
Ekaterina A. Khait
Olga A. Perminova
Tatiana E. Pak
Svetlana G. Lazareva
Liubov V. Aleshina
Dmitriy A. Suprun
Anna N. Galustyan
Olga A. Rychkova
Tatiana A. Romanova
Alfia I. Aminova
Galina V. Dulova
author_facet Viktor V. Romanenko
Leyla S. Namazova-Baranova
Alina A. Kotova
Kamilla E. Efendieva
Anna A. Ruleva
Ekaterina A. Khait
Olga A. Perminova
Tatiana E. Pak
Svetlana G. Lazareva
Liubov V. Aleshina
Dmitriy A. Suprun
Anna N. Galustyan
Olga A. Rychkova
Tatiana A. Romanova
Alfia I. Aminova
Galina V. Dulova
author_sort Viktor V. Romanenko
collection DOAJ
description 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.
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spelling doaj-art-d05dd0dc0ddc439b9eceb09f74d85f002025-08-03T19:21:31ZrusUnion of pediatricians of RussiaПедиатрическая фармакология1727-57762500-30892024-07-0121321322510.15690/pf.v21i3.27432068Results of a clinical study of the influenza tetravalent inactivated subunit adjuvant vaccine Grippol Quadrivalent in children aged 6 months to 5 years (inclusive)Viktor V. Romanenko0Leyla S. Namazova-Baranova1Alina A. Kotova2Kamilla E. Efendieva3Anna A. Ruleva4Ekaterina A. Khait5Olga A. Perminova6Tatiana E. Pak7Svetlana G. Lazareva8Liubov V. Aleshina9Dmitriy A. Suprun10Anna N. Galustyan11Olga A. Rychkova12Tatiana A. Romanova13Alfia I. Aminova14Galina V. Dulova15Ural State Medical UniversityResearch Institute of Pediatrics and Children’s Health in Petrovsky National Research Centre of SurgeryThe Center for Hygiene and Epidemiology in the SverdlovskResearch Institute of Pediatrics and Children’s Health in Petrovsky National Research Centre of SurgeryChildren’s Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological AgencyChildren’s city outpatients clinic № 45 of the Nevsky districtChildren’s city outpatients clinic № 5LLC “PiterKlinika”LLC “Energiia zdorovia”LLC “Tsentr DNK-issledovanii”Municipal Polyclinic № 106, Children’s polyclinic department № 37LLC “Meditsinskie tekhnologii”Tyumen State Medical UniversityN.N. Ivanova Samara Regional Children’s Clinical HospitalG.N. Speransky Children’s City Clinical Hospital № 9LLC “Klinika UZI 4D”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.https://www.pedpharma.ru/jour/article/view/2433influenza virus infectionvaccinizationinfluenza tetravalent inactivated subunit adjuvant vaccinegrippol quadrivalent
spellingShingle Viktor V. Romanenko
Leyla S. Namazova-Baranova
Alina A. Kotova
Kamilla E. Efendieva
Anna A. Ruleva
Ekaterina A. Khait
Olga A. Perminova
Tatiana E. Pak
Svetlana G. Lazareva
Liubov V. Aleshina
Dmitriy A. Suprun
Anna N. Galustyan
Olga A. Rychkova
Tatiana A. Romanova
Alfia I. Aminova
Galina V. Dulova
Results of a clinical study of the influenza tetravalent inactivated subunit adjuvant vaccine Grippol Quadrivalent in children aged 6 months to 5 years (inclusive)
Педиатрическая фармакология
influenza virus infection
vaccinization
influenza tetravalent inactivated subunit adjuvant vaccine
grippol quadrivalent
title Results of a clinical study of the influenza tetravalent inactivated subunit adjuvant vaccine Grippol Quadrivalent in children aged 6 months to 5 years (inclusive)
title_full Results of a clinical study of the influenza tetravalent inactivated subunit adjuvant vaccine Grippol Quadrivalent in children aged 6 months to 5 years (inclusive)
title_fullStr Results of a clinical study of the influenza tetravalent inactivated subunit adjuvant vaccine Grippol Quadrivalent in children aged 6 months to 5 years (inclusive)
title_full_unstemmed Results of a clinical study of the influenza tetravalent inactivated subunit adjuvant vaccine Grippol Quadrivalent in children aged 6 months to 5 years (inclusive)
title_short Results of a clinical study of the influenza tetravalent inactivated subunit adjuvant vaccine Grippol Quadrivalent in children aged 6 months to 5 years (inclusive)
title_sort results of a clinical study of the influenza tetravalent inactivated subunit adjuvant vaccine grippol quadrivalent in children aged 6 months to 5 years inclusive
topic influenza virus infection
vaccinization
influenza tetravalent inactivated subunit adjuvant vaccine
grippol quadrivalent
url https://www.pedpharma.ru/jour/article/view/2433
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