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
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 quadrivalen...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2021-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | http://dx.doi.org/10.1080/21645515.2021.1983387 |
| _version_ | 1797673282635300864 |
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| author | Stephanie Pepin Jean-François Nicolas Henryk Szymanski Isabel Leroux-Roels Thomas Schaum Marc Bonten Giancarlo Icardi Anju Shrestha Cynthia Tabar The QHD00011 study team |
| author_facet | Stephanie Pepin Jean-François Nicolas Henryk Szymanski Isabel Leroux-Roels Thomas Schaum Marc Bonten Giancarlo Icardi Anju Shrestha Cynthia Tabar The QHD00011 study team |
| author_sort | Stephanie Pepin |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-11T21:42:16Z |
| format | Article |
| id | doaj.art-00843d9ce111450f920635f631acd873 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T21:42:16Z |
| publishDate | 2021-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-00843d9ce111450f920635f631acd8732023-09-26T12:43:42ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2021-12-0117125475548610.1080/21645515.2021.19833871983387Immunogenicity 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 trialStephanie Pepin0Jean-François Nicolas1Henryk Szymanski2Isabel Leroux-Roels3Thomas Schaum4Marc Bonten5Giancarlo Icardi6Anju Shrestha7Cynthia Tabar8The QHD00011 study teamSanofi PasteurCentre Hospitalier Lyon-SudSt Hedwig of Silesia Hospital TrzebnicaGhent University HospitalRED-InstitutUniversity Medical Center UtrechtOspedale Policlinico S. Martino IRCCS, University of GenoaSanofi PasteurSanofi PasteurA 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.http://dx.doi.org/10.1080/21645515.2021.1983387high-dose influenza vaccineinfluenza vaccinationolder adultsimmunogenicitysafetyphase iii trial |
| spellingShingle | Stephanie Pepin Jean-François Nicolas Henryk Szymanski Isabel Leroux-Roels Thomas Schaum Marc Bonten Giancarlo Icardi Anju Shrestha Cynthia Tabar The QHD00011 study team 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 Human Vaccines & Immunotherapeutics high-dose influenza vaccine influenza vaccination older adults immunogenicity safety phase iii trial |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | high-dose influenza vaccine influenza vaccination older adults immunogenicity safety phase iii trial |
| url | http://dx.doi.org/10.1080/21645515.2021.1983387 |
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