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.

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RESEARCH PRODUCT

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.

Pepin S.Nicolas J. -F.Szymanski H.Leroux-roels I.Schaum T.Bonten M.Icardi G.Shrestha A.Tabar C.Van Damme P.Donazzolo Y.Launay O.Schurholz T.Sturm K.Toursarkissian N.Schenkenberger I.Vitale F.Brzostek J.Pajek B.Miszczak-kowalska E.Khoury R.Grosbois M. -A.Gauby C.Lacroix I.Souzy F.Pandey A.Yandle S.Lupinsky N.Goulet F.Milcamps L.De Sousa J.Lardon M.Lyko V.Blattmann A.Janosczyk H.Samson S.De Bruijn I.

subject

safety Adult IMPACT Influenza vaccine Immunology immunogenicity Antibodies Viral Quadrivalent Influenza Vaccine older adult Immunogenicity Vaccine Double-Blind Method Influenza Human Medicine and Health Sciences Immunology and Allergy Medicine Humans Vaccines Combined older adults Pharmacology business.industry Immunogenicity ADULTS Hemagglutination Inhibition Tests EFFICACY Virology influenza vaccination High-dose influenza vaccine Vaccines Inactivated Influenza Vaccines Phase III trial business

description

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.

year	journal	country	edition	language
2021-01-01	Human vaccinesimmunotherapeutics

10.1080/21645515.2021.1983387 https://pubmed.ncbi.nlm.nih.gov/35674507