tetano
Editor, Senior Moderator
Hum Vaccin Immunother
. 2021 Oct 29;1-12.
doi: 10.1080/21645515.2021.1983387. Online ahead of print.
Immunogenicity and safety of a quadrivalent high-dose inactivated influenza vaccine compared with a standard-dose quadrivalent influenza vaccine in healthy people aged 60 years or older: a randomized Phase III trial
Stephanie Pepin[SUP] 1 [/SUP], Jean-François Nicolas[SUP] 2 [/SUP], Henryk Szymanski[SUP] 3 [/SUP], Isabel Leroux-Roels[SUP] 4 [/SUP], Thomas Schaum[SUP] 5 [/SUP], Marc Bonten[SUP] 6 [/SUP], Giancarlo Icardi[SUP] 7 [/SUP], Anju Shrestha[SUP] 8 [/SUP], Cynthia Tabar[SUP] 1 [/SUP], QHD00011 study team
Affiliations
Abstract
A quadrivalent high-dose inactivated influenza vaccine (IIV4-HD) is licensed for adults ≥65 y of age based on immunogenicity and efficacy studies. However, IIV4-HD has not been evaluated in adults aged 60-64 y. This study compared immunogenicity and safety of IIV4-HD with a standard-dose quadrivalent influenza vaccine (IIV4-SD) in adults aged ≥60 y. This Phase III, randomized, modified double-blind, active-controlled study enrolled 1,528 participants aged ≥60 y, randomized 1:1 to a single injection of IIV4-HD or IIV4-SD. Hemagglutination inhibition (HAI) geometric mean titers (GMTs) were measured at baseline and D 28 and seroconversion assessed. Safety was described for 180 d after vaccination. The primary immunogenicity objective was superiority of IIV4-HD versus IIV4-SD, for all four influenza strains 28 d post vaccination in participants aged 60-64 and ≥65 y. IIV4-HD induced a superior immune response versus IIV4-SD in terms of GMTs in participants aged 60-64 y and those aged ≥65 y for all four influenza strains. IIV4-HD induced higher GMTs in those aged 60-64 y than those aged ≥65 y. Seroconversion rates were higher for IIV4-HD versus IIV4-SD in each age-group for all influenza strains. Both vaccines were well tolerated in participants ≥60 y of age, with no safety concerns identified. More solicited reactions were reported with IIV4-HD than with IIV4-SD. IIV4-HD provided superior immunogenicity versus IIV4-SD and was well tolerated in adults aged ≥60 y. IIV4-HD is assumed to offer improved protection against influenza compared with IIV4-SD in adults aged ≥60 y, as was previously assessed for adults aged ≥65 y.
Keywords: High-dose influenza vaccine; Phase III trial; immunogenicity; influenza vaccination; older adults; safety.
. 2021 Oct 29;1-12.
doi: 10.1080/21645515.2021.1983387. Online ahead of print.
Immunogenicity and safety of a quadrivalent high-dose inactivated influenza vaccine compared with a standard-dose quadrivalent influenza vaccine in healthy people aged 60 years or older: a randomized Phase III trial
Stephanie Pepin[SUP] 1 [/SUP], Jean-François Nicolas[SUP] 2 [/SUP], Henryk Szymanski[SUP] 3 [/SUP], Isabel Leroux-Roels[SUP] 4 [/SUP], Thomas Schaum[SUP] 5 [/SUP], Marc Bonten[SUP] 6 [/SUP], Giancarlo Icardi[SUP] 7 [/SUP], Anju Shrestha[SUP] 8 [/SUP], Cynthia Tabar[SUP] 1 [/SUP], QHD00011 study team
Affiliations
- PMID: 34714720
- DOI: 10.1080/21645515.2021.1983387
Abstract
A quadrivalent high-dose inactivated influenza vaccine (IIV4-HD) is licensed for adults ≥65 y of age based on immunogenicity and efficacy studies. However, IIV4-HD has not been evaluated in adults aged 60-64 y. This study compared immunogenicity and safety of IIV4-HD with a standard-dose quadrivalent influenza vaccine (IIV4-SD) in adults aged ≥60 y. This Phase III, randomized, modified double-blind, active-controlled study enrolled 1,528 participants aged ≥60 y, randomized 1:1 to a single injection of IIV4-HD or IIV4-SD. Hemagglutination inhibition (HAI) geometric mean titers (GMTs) were measured at baseline and D 28 and seroconversion assessed. Safety was described for 180 d after vaccination. The primary immunogenicity objective was superiority of IIV4-HD versus IIV4-SD, for all four influenza strains 28 d post vaccination in participants aged 60-64 and ≥65 y. IIV4-HD induced a superior immune response versus IIV4-SD in terms of GMTs in participants aged 60-64 y and those aged ≥65 y for all four influenza strains. IIV4-HD induced higher GMTs in those aged 60-64 y than those aged ≥65 y. Seroconversion rates were higher for IIV4-HD versus IIV4-SD in each age-group for all influenza strains. Both vaccines were well tolerated in participants ≥60 y of age, with no safety concerns identified. More solicited reactions were reported with IIV4-HD than with IIV4-SD. IIV4-HD provided superior immunogenicity versus IIV4-SD and was well tolerated in adults aged ≥60 y. IIV4-HD is assumed to offer improved protection against influenza compared with IIV4-SD in adults aged ≥60 y, as was previously assessed for adults aged ≥65 y.
Keywords: High-dose influenza vaccine; Phase III trial; immunogenicity; influenza vaccination; older adults; safety.