TY - JOUR
T1 - 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
T2 - a randomized Phase III trial
AU - Pepin, Stephanie
AU - Nicolas, Jean-François
AU - Szymanski, Henryk
AU - Leroux-Roels, Isabel
AU - Schaum, Thomas
AU - Bonten, Marc
AU - Icardi, Giancarlo
AU - Shrestha, Anju
AU - Tabar, Cynthia
N1 - Funding Information:
The study was funded by Sanofi Pasteur. The authors thank Niki Panagiotaki and Nick Tsimplis from Lucid Group Communications Ltd, Marlow, Buckinghamshire, UK for providing medical writing support, which was funded by Sanofi in accordance with Good Publication Practice (GPP3) guidelines. Responsibility for all opinions, conclusions, and interpretation of data lies with the authors. No author was paid for services involved in writing this manuscript. The QHD00011 study investigators included Isabel Leroux-Roels, Pierre Van Damme, Yves Donazzolo, Jean-François Nicolas, Odile Launay, Thomas Schürholz, Thomas Schaum, Kerstin Sturm, Nicole Toursarkissian, Isabelle Schenkenberger, Giancarlo Icardi, Francesco Vitale, Marc Bonten, Jerzy Brzostek, Barbara Pajek, Edyta Miszczak-Kowalska, and Henryk Szymanski. The Study Team included Rawia Khoury, Marie-Ange Grosbois, Corentin Gauby, Isabelle Lacroix, Fabienne Souzy, Aseem Pandey, Scott Yandle, Nicole Lupinsky, France Goulet, Laurence Milcamps, Jennifer De Sousa, Marine Lardon, Valerie Lyko, Arielle Blattmann, Helene Janosczyk, Sandrine Samson and Iris De Bruijn.
Publisher Copyright:
© 2021 The Author(s). Published with license by Taylor & Francis Group, LLC.
PY - 2021/12/2
Y1 - 2021/12/2
N2 - 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.
AB - 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.
KW - High-dose influenza vaccine
KW - Phase III trial
KW - immunogenicity
KW - influenza vaccination
KW - older adults
KW - safety
UR - http://www.scopus.com/inward/record.url?scp=85118853724&partnerID=8YFLogxK
U2 - 10.1080/21645515.2021.1983387
DO - 10.1080/21645515.2021.1983387
M3 - Article
C2 - 34714720
SN - 2164-5515
VL - 17
SP - 5475
EP - 5486
JO - Human vaccines & immunotherapeutics
JF - Human vaccines & immunotherapeutics
IS - 12
ER -