The results of clinical trial on immunogenicity of adjuvanted quadrivalent inactivated subunit influenza vaccine Grippol Quadrivalent in pediatric population 6 to 17 years old
| Autor: | I.V. Feldblum, A.U. Sabitov, O.P. Kovtun, A.V. Ankudinova, V.V. Romanenko |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Environmental Engineering Influenza vaccine 030106 microbiology lcsh:QR1-502 complex mixtures lcsh:Microbiology lcsh:Physiology Industrial and Manufacturing Engineering Virus 03 medical and health sciences 0302 clinical medicine lcsh:Zoology Medicine lcsh:QL1-991 030212 general & internal medicine Seroconversion Hemagglutination assay lcsh:QP1-981 biology business.industry Immunogenicity Virology Clinical trial biology.protein Antibody business Pediatric population |
| Zdroj: | BIO Web of Conferences, Vol 22, p 02001 (2020) |
| ISSN: | 2117-4458 |
| DOI: | 10.1051/bioconf/20202202001 |
| Popis: | Russian health care workers currently use trivalent influenza vaccines with a strain of a single lineage of type B virus. The purpose of our study was to evaluate the immunogenicity of an adjuvanted quadrivalent inactivated subunit influenza vaccine Grippol Quadrivalent in pediatric population 6 to 17 years old. We compared this new vaccine to a trivalent Grippol Plus vaccine in terms of immunogenicity against certain strains of influenza virus. A multicenter double-blind randomized controlled clinical study was conducted in 440 pediatric subjects (age groups: 6 to 11; 12 to 17 y.o.); 221 subjects received Grippol Quadrivalent, 219 – Grippol Plus. Vaccine immunogenicity was evaluated by seroprotection rate (SPR), seroconversion rate (SCR), geometric mean titer (GMT) of antibodies, and an X-fold rise in antibodies level (↑GMT). Antibodies quantification was done using hemagglutination inhibition assay (HAI) in serial serum dilutions. No significant differences were found between the two vaccines’ performance against A(H1N1), A(H3N2) strains or Victoria B virus. With respect to type A virus, both vaccines satisfied three of CPMP criteria (SPR, SCR, ↑GMT). With respect to Victoria B virus, the two vaccines met but one CPMP criterion (↑GMT). The immunogenicity against Yamagata B virus was evaluated only for Grippol Quadrivalent vaccine which met two of CPMP requirements (SCR, ↑GMT). Our findings suggest that in terms of its prophylactic efficiency, Grippol Quadrivalent vaccine is no inferior to the Grippol Plus one. |
| Databáze: | OpenAIRE |
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