Reactogenicity, Safety and Immunogenicity of Domestic Flu-M Inactivated Split Influenza Vaccine for the Immunization of Adults Aged Between 18 and 60

Фельдблюм, И. В.; Субботина, К. А.; Новгородова, С Д; Игнатьев, Г. М.; Алыева, М. Х.; Ерофеева, М. К.; Орловский, В. Г.; Ленева, И. А.; Melnikov, Semyon; Казакова, Е. В.; Начарова, Е. П.; Трухин, В. П.

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

Cited by 3 publications

(1 citation statement)

References 3 publications

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“…В 2018 г. была зарегистрирована гриппозная инактивированная расщеплённая вакцина «Флю-М», разработанная Санкт-Петербургским научно-исследовательским институтом вакцин и сывороток (СПбНИИВС). Клинические исследования на взрослых от 18 до 60 лет, а затем на детях в возрасте от 6 месяцев до 9 лет показали, что данная вакцина характеризуется хорошей переносимостью, высоким профилем безопасности и достаточной иммуногенностью [12][13][14]. В данной статье представлены результаты изучения прививочных свойств вакцины «Флю-М» для детей в возрасте от 6 до17 лет в сравнении с гриппозной сплитвакциной «Ультрикс».…”

Section: Introductionunclassified

Clinical trial of tolerability, safety and immunogenicity of influenza inactivated split-vaccine Flu-M in children aged 6 to 17 years

Korolyuk,

Kraeva,

Zazimko

et al. 2024

jour

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Purpose. To evaluate the tolerability, safety and immunogenicity of influenza inactivated split flu vaccine Flu-M during single immunization of children aged 6 to 17 years.Materials and methods. A multicentre double-blind comparative randomised clinical trial of influenza inactivated split vaccine Flu-M for immunisation of children aged 6 to 17 years (the reference agent – Ultrix vaccine) was conducted. Children aged 12 to 17 years inclusive (300 children) were studied at stage I, and children aged 6 to 12 years (300 children) at stage II. Volunteers of each age category were randomised 1:1 into 2 groups comparable in sex and age, one was vaccinated with Flu-M vaccine and the other with Ultrix vaccine. The follow-up, including various laboratory and clinical tests, lasted for 28 days from the time of vaccination.Results. Both vaccines were well tolerated by children aged 12 to 17 years and by children aged 6 to 12 years. There were no severe or serious adverse events. By all criteria of immunogenicity evaluation, vaccine Flu-M was not inferior to the comparison vaccine Ultrix.Conclusion. Influenza inactivated split Flu-M vaccine produced by SPbNIIVS is approved for use for specific prophylaxis of influenza in children aged 6 to 17 years in the Russian Federation, the Republic of Belarus, Latin America and the Caribbean.The trial is registered at ClinicalTrials. gov (NCT 05317767).

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Section: Introductionunclassified

Clinical trial of tolerability, safety and immunogenicity of influenza inactivated split-vaccine Flu-M in children aged 6 to 17 years

Korolyuk,

Kraeva,

Zazimko

et al. 2024

jour

View full text Add to dashboard Cite

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Flu yesterday, today and tomorrow. The results of monitoring immunization and morbidity in the epidemic seasons 2019–2020, 2020–2021, 2021–2022, 2022–2023

Nikiforov,

Polibin,

Suranova

et al. 2024

Epidemiology and Infectious Diseases

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The article presents the clinical and epidemiological characteristics of influenza in the 2022-2023 season and data on the monitoring of vaccination, morbidity and deaths in recent years. The high efficiency of influenza vaccination was noted. The influenza vaccines registered in Russia are considered, their features, composition and advantages are indicated. Recommendations for their use are given, including aspects of vaccination of persons belonging to risk groups

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Clinical trial of tolerability, safety, and immunogenicity of the Russian influenza inactivated split vaccine Flu-m in children from 6 months to 9 years of age

Korolyuk,

Zazimko,

Kraeva

et al. 2023

jour

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Purpose: To study the reactogenicity, safety and immunogenicity of the Russian vaccine Flu-M in comparison with Vaxigrip vaccine for influenza prevention in children aged from 6 months to 9 years (phase III).Materials and Methods. In 2021, a clinical study was conducted in which children aged 6 months to 9 years were immunized with Flu-M vaccine (produced by SPbSRIVS, Russia) and Vaxigrip vaccine (produced by Sanofi Pasteur S.A., France). After randomization one group of children was vaccinated with Flu-M, the other with Vaxigrip, and monitored for 180±3 days after vaccination. Children vaccinated between 3 and 9 years of age were studied in phase I, and between 6 months and 3 years of age in phase II. Tolerability and safety were assessed by the frequency and extent of adverse events, as well as by the assessment of vital signs and physical examination. Immunological efficacy assessment criteria were geometric mean antibody titer, seroconversion level, seroconversion factor, seroprotection level.Results. Both vaccines (Flu-M and Vaxigrip) were shown to be well tolerated by children of both age groups. No serious adverse events or severe adverse events were reported in the study. Immunological efficacy criteria were achieved for both vaccines for all strains of influenza virus in children of both age groups at 28 and 56 days after vaccination. No cases of influenza or acute respiratory infections were seen at 180±3 days postvaccination.Conclusion. The results of the clinical study show that the Flu-M and Vaxigrip vaccines are comparable in both age groups of children.The trial is registered at ClinicalTrials.gov (NCT 05470582).

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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

Cited by 3 publications

References 3 publications

Clinical trial of tolerability, safety and immunogenicity of influenza inactivated split-vaccine Flu-M in children aged 6 to 17 years

Clinical trial of tolerability, safety and immunogenicity of influenza inactivated split-vaccine Flu-M in children aged 6 to 17 years

Flu yesterday, today and tomorrow. The results of monitoring immunization and morbidity in the epidemic seasons 2019–2020, 2020–2021, 2021–2022, 2022–2023

Clinical trial of tolerability, safety, and immunogenicity of the Russian influenza inactivated split vaccine Flu-m in children from 6 months to 9 years of age

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