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Safety and immunogenicity of meningococcal ACWY CRM -conjugate vaccine in children, adolescents, and adults in Russia

Ilyina, N and Kharit, S and Namazova-Baranova, L and Asatryan, A and Benashvili, M and Tkhostova, E and Bhusal, C and Arora, AK (2014) Safety and immunogenicity of meningococcal ACWY CRM -conjugate vaccine in children, adolescents, and adults in Russia. Hum Vaccin Immunother .

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Abstract

Neisseria meningitidis is the leading cause of bacterial invasive infections in people aged<15 years in the Russian Federation. The aim of this phase III, multicenter, open-label study was to assess the immunogenicity and safety of the quadrivalent meningococcal CRM 197-conjugate vaccine MenACWY when administered to healthy Russian subjects aged 2 years and above. A total of 197 subjects were immunized with a single dose of the vaccine, and serogroup-specific serum bactericidal activity was measured pre and 1-month post-vaccination with human complement (hSBA) serum titers. Regardless of baseline serostatus, 1 month after a single dose of MenACWY-CRM 197 85% (95%CI, 79-90%) of subjects showed serologic response against serogroup A, 74% (67-80%) against serogroup C, 60% (53-67%) against serogroup W, and 83% (77-88%) against serogroup Y. The percentage of subjects with hSBA titers >/= 1:8 1 month after vaccination was 89% (83-93%) against serogroup A, 84% (78-89%) against serogroup C, 97% (93-99%) against serogroup W, and 88% (82-92%) against serogroup Y. Comparable results were obtained across all subjects: children (2 to 10 years), adolescents (11 to 17 years), and adults (>/=18 years). The MenACWY-CRM 197 vaccine showed with an acceptable safety profile and was well tolerated across all age groups, with no serious adverse events or deaths reported during the study. In conclusion, a single dose of meningococcal MenACWY-CRM 197 vaccine is immunogenic and has an acceptable safety profile, provides a broad protection against the most frequent epidemic serogroups, and is a suitable alternative to currently available unconjugated monovalent or bivalent polysaccharide vaccines in Russia

Item Type: Article
Additional Information: NIBR author: Benashvili, M institute: NIBR contributor address:
Date Deposited: 13 Oct 2015 13:12
Last Modified: 13 Oct 2015 13:12
URI: https://oak.novartis.com/id/eprint/22603

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