tetano
Editor, Senior Moderator
Vaccine
. 2023 Mar 9;S0264-410X(23)00225-6.
doi: 10.1016/j.vaccine.2023.02.071. Online ahead of print.
Superior immunogenicity of high-dose quadrivalent inactivated influenza vaccine versus Standard-Dose vaccine in Japanese Adults ≥ 60 years of age: Results from a phase III, randomized clinical trial
Leilani Sanchez[SUP] 1 [/SUP], Takahiro Nakama[SUP] 2 [/SUP], Hideaki Nagai[SUP] 3 [/SUP], Osamu Matsuoka[SUP] 4 [/SUP], Satoshi Inoue[SUP] 5 [/SUP], Takahiro Inoue[SUP] 2 [/SUP], Anju Shrestha[SUP] 6 [/SUP], Aseem Pandey[SUP] 6 [/SUP], Lee-Jah Chang[SUP] 6 [/SUP], Iris De Bruijn[SUP] 7 [/SUP]; QHD00010 Study Group
Affiliations
Abstract
Background: A high-dose, split-virion inactivated quadrivalent influenza vaccine (IIV4-HD; Sanofi) is being used for the prevention of influenza in multiple countries. This study examined the immunogenicity and safety of the IIV4-HD vaccine administered intramuscularly (IM) compared with a locally licensed standard-dose influenza vaccine (IIV4-SD) administered subcutaneously (SC) in Japan.
Methods: This was a phase III, randomized, modified double-blind, active-controlled, multi-center study in older adults ≥ 60 years of age conducted during the Northern Hemisphere (NH) influenza season of 2020-21 in Japan. Participants were randomized in a 1:1 ratio to receive a single IM injection of IIV4-HD or SC injection of IIV4-SD. Hemagglutination inhibition antibody and seroconversion rates were measured at baseline and day 28. Solicited reactions were collected for up to 7 days after vaccination, unsolicited adverse events up to 28 days after vaccination, and serious adverse events throughout the study.
Results: The study included 2100 adults ≥ 60 years of age. IIV4-HD given IM induced superior immune responses versus IIV4-SD given SC as assessed by geometric mean titers for all four influenza strains. Superior seroconversion rates were also observed for IIV4-HD compared to IIV4-SD for all influenza strains. The safety profiles of IIV4-HD and IIV4-SD were similar. IIV4-HD was well tolerated in participants, with no safety concerns identified.
Conclusions: IIV4-HD provided superior immunogenicity versus IIV4-SD and was well tolerated in participants ≥ 60 years of age in Japan. With superior immunogenicity based on the multiple randomized controlled trials and real-world evidence of trivalent high-dose formulation, IIV4-HD is expected to be the first differentiated influenza vaccine in Japan that offer a greater protection against influenza and its complications in adults 60 years of age and older.
Study registration: NCT04498832 (clinicaltrials.gov); U1111-1225-1085 (who.int).
Keywords: Clinical study; High-dose quadrivalent influenza vaccine; Immunogenicity; Japan; Older adults; Safety.
. 2023 Mar 9;S0264-410X(23)00225-6.
doi: 10.1016/j.vaccine.2023.02.071. Online ahead of print.
Superior immunogenicity of high-dose quadrivalent inactivated influenza vaccine versus Standard-Dose vaccine in Japanese Adults ≥ 60 years of age: Results from a phase III, randomized clinical trial
Leilani Sanchez[SUP] 1 [/SUP], Takahiro Nakama[SUP] 2 [/SUP], Hideaki Nagai[SUP] 3 [/SUP], Osamu Matsuoka[SUP] 4 [/SUP], Satoshi Inoue[SUP] 5 [/SUP], Takahiro Inoue[SUP] 2 [/SUP], Anju Shrestha[SUP] 6 [/SUP], Aseem Pandey[SUP] 6 [/SUP], Lee-Jah Chang[SUP] 6 [/SUP], Iris De Bruijn[SUP] 7 [/SUP]; QHD00010 Study Group
Affiliations
- PMID: 36906404
- DOI: 10.1016/j.vaccine.2023.02.071
Abstract
Background: A high-dose, split-virion inactivated quadrivalent influenza vaccine (IIV4-HD; Sanofi) is being used for the prevention of influenza in multiple countries. This study examined the immunogenicity and safety of the IIV4-HD vaccine administered intramuscularly (IM) compared with a locally licensed standard-dose influenza vaccine (IIV4-SD) administered subcutaneously (SC) in Japan.
Methods: This was a phase III, randomized, modified double-blind, active-controlled, multi-center study in older adults ≥ 60 years of age conducted during the Northern Hemisphere (NH) influenza season of 2020-21 in Japan. Participants were randomized in a 1:1 ratio to receive a single IM injection of IIV4-HD or SC injection of IIV4-SD. Hemagglutination inhibition antibody and seroconversion rates were measured at baseline and day 28. Solicited reactions were collected for up to 7 days after vaccination, unsolicited adverse events up to 28 days after vaccination, and serious adverse events throughout the study.
Results: The study included 2100 adults ≥ 60 years of age. IIV4-HD given IM induced superior immune responses versus IIV4-SD given SC as assessed by geometric mean titers for all four influenza strains. Superior seroconversion rates were also observed for IIV4-HD compared to IIV4-SD for all influenza strains. The safety profiles of IIV4-HD and IIV4-SD were similar. IIV4-HD was well tolerated in participants, with no safety concerns identified.
Conclusions: IIV4-HD provided superior immunogenicity versus IIV4-SD and was well tolerated in participants ≥ 60 years of age in Japan. With superior immunogenicity based on the multiple randomized controlled trials and real-world evidence of trivalent high-dose formulation, IIV4-HD is expected to be the first differentiated influenza vaccine in Japan that offer a greater protection against influenza and its complications in adults 60 years of age and older.
Study registration: NCT04498832 (clinicaltrials.gov); U1111-1225-1085 (who.int).
Keywords: Clinical study; High-dose quadrivalent influenza vaccine; Immunogenicity; Japan; Older adults; Safety.