Background: Vaccination against seasonal influenza is recommended for all children with a history of medical conditions placing them at increased risk of influenza-associated complications. The immunogenicity and efficacy of conventional influenza vaccines among young children are suboptimal; one strategy to enhance these is adjuvantation. We present immunogenicity and safety data for an MF59-adjuvanted quadrivalent influenza vaccine (aIIV4) in healthy children and those at a high risk of influenza-associated complications, based on the results of a recently completed phase III study. Methods: Children 6 months to 5 years of age (N = 10,644) were enrolled. The study was conducted across northern hemisphere seasons 2013-2014 and 2014-2015. Subjects received either aIIV4 or a nonadjuvanted comparator influenza vaccine. Antibody responses were assessed by hemagglutination inhibition assay against vaccine and heterologous strains. Long-term antibody persistence was assessed (ClinicalTrials.gov: NCT01964989). Results: aIIV4 induced significantly higher antibody titers than nonadjuvanted vaccine in high-risk subjects. aIIV4 antibody responses were of similar magnitude in high-risk and healthy subjects. Incidence of solicited local and systemic adverse events (AEs) was slightly higher in aIIV4 than nonadjuvanted vaccinees, in both the healthy and high-risk groups. Incidence of unsolicited AEs, serious AEs and AEs of special interest were similar for adjuvanted and nonadjuvanted vaccinees in the healthy and high-risk groups. Conclusion: aIIV4 was more immunogenic than nonadjuvanted vaccine in both the healthy and high-risk study groups. The reactogenicity and safety profiles of aIIV4 and the nonadjuvanted vaccine were acceptable and similar in 6-month- to 5-year-old high-risk and healthy children.

Immunogenicity and safety of an MF59-adjuvanted quadrivalent seasonal influenza vaccine in young children at high risk of influenza-associated complications: A Phase III, Randomized, observer-blind, multicenter clinical trial / Esposito, S.; Fling, J.; Chokephaibulkit, K.; De Bruijn, M.; Oberye, J.; Zhang, B.; Vossen, J.; Heijnen, E.; Smolenov, I.. - In: THE PEDIATRIC INFECTIOUS DISEASE JOURNAL. - ISSN 0891-3668. - 39:8(2020), pp. E185-E191. [10.1097/INF.0000000000002727]

Immunogenicity and safety of an MF59-adjuvanted quadrivalent seasonal influenza vaccine in young children at high risk of influenza-associated complications: A Phase III, Randomized, observer-blind, multicenter clinical trial

Esposito S.;
2020-01-01

Abstract

Background: Vaccination against seasonal influenza is recommended for all children with a history of medical conditions placing them at increased risk of influenza-associated complications. The immunogenicity and efficacy of conventional influenza vaccines among young children are suboptimal; one strategy to enhance these is adjuvantation. We present immunogenicity and safety data for an MF59-adjuvanted quadrivalent influenza vaccine (aIIV4) in healthy children and those at a high risk of influenza-associated complications, based on the results of a recently completed phase III study. Methods: Children 6 months to 5 years of age (N = 10,644) were enrolled. The study was conducted across northern hemisphere seasons 2013-2014 and 2014-2015. Subjects received either aIIV4 or a nonadjuvanted comparator influenza vaccine. Antibody responses were assessed by hemagglutination inhibition assay against vaccine and heterologous strains. Long-term antibody persistence was assessed (ClinicalTrials.gov: NCT01964989). Results: aIIV4 induced significantly higher antibody titers than nonadjuvanted vaccine in high-risk subjects. aIIV4 antibody responses were of similar magnitude in high-risk and healthy subjects. Incidence of solicited local and systemic adverse events (AEs) was slightly higher in aIIV4 than nonadjuvanted vaccinees, in both the healthy and high-risk groups. Incidence of unsolicited AEs, serious AEs and AEs of special interest were similar for adjuvanted and nonadjuvanted vaccinees in the healthy and high-risk groups. Conclusion: aIIV4 was more immunogenic than nonadjuvanted vaccine in both the healthy and high-risk study groups. The reactogenicity and safety profiles of aIIV4 and the nonadjuvanted vaccine were acceptable and similar in 6-month- to 5-year-old high-risk and healthy children.
2020
Immunogenicity and safety of an MF59-adjuvanted quadrivalent seasonal influenza vaccine in young children at high risk of influenza-associated complications: A Phase III, Randomized, observer-blind, multicenter clinical trial / Esposito, S.; Fling, J.; Chokephaibulkit, K.; De Bruijn, M.; Oberye, J.; Zhang, B.; Vossen, J.; Heijnen, E.; Smolenov, I.. - In: THE PEDIATRIC INFECTIOUS DISEASE JOURNAL. - ISSN 0891-3668. - 39:8(2020), pp. E185-E191. [10.1097/INF.0000000000002727]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2881462
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