{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T03:46:07Z","timestamp":1787802367563,"version":"build-2784847793"},"reference-count":35,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,4,3]],"date-time":"2024-04-03T00:00:00Z","timestamp":1712102400000},"content-version":"vor","delay-in-days":2,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Influenza Resp Viruses"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>We assessed the relative vaccine effectiveness (rVE) of high\u2010dose quadrivalent influenza vaccine (QIV\u2010HD) versus standard\u2010dose quadrivalent influenza vaccine (QIV\u2010SD) in preventing respiratory or cardiovascular hospitalizations in older adults.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>FinFluHD was a phase 3b\/4 modified double\u2010blind, randomized pragmatic trial. Enrolment of 121,000 adults \u226565\u2009years was planned over three influenza seasons (October to December 2019\u20132021). Participants received a single injection of QIV\u2010HD or QIV\u2010SD. The primary endpoint was first occurrence of an unscheduled acute respiratory or cardiovascular hospitalization (ICD\u201010 primary discharge J\/I codes), from \u226514\u2009days post\u2010vaccination until May 31. The study was terminated after one season due to COVID\u201019; follow\u2010up data for 2019\u20132020 are presented.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      33,093 participants were vaccinated (QIV\u2010HD,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200916,549; QIV\u2010SD,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200916,544); 529 respiratory or cardiovascular hospitalizations (QIV\u2010HD,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009257; QIV\u2010SD,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009272) were recorded. The rVE of QIV\u2010HD versus QIV\u2010SD to prevent respiratory\/cardiovascular hospitalizations was 5.5% (95% CI, \u221212.4 to 20.7). When prevention of respiratory and cardiovascular hospitalizations were considered separately, rVE estimates of QIV\u2010HD versus QIV\u2010SD were 5.4% (95% CI, \u221228.0 to 30.1) and 7.1% (95% CI, \u221215.0 to 25.0), respectively. Serious adverse reactions were &lt;0.01% in both groups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Despite insufficient statistical power due to the impact of COVID\u201019, rVE point estimates demonstrated a trend toward a benefit of QIV\u2010HD over QIV\u2010SD. QIV\u2010HD was associated with lower respiratory or cardiovascular hospitalization rates than QIV\u2010SD, with a comparable safety profile. Adequately powered studies conducted over multiple influenza seasons are needed to determine statistical significance of QIV\u2010HD compared with QIV\u2010SD against preventing respiratory and cardiovascular hospitalizations.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Trial Registration:<\/jats:bold>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      number: NCT04137887\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/irv.13270","type":"journal-article","created":{"date-parts":[[2024,4,3]],"date-time":"2024-04-03T20:13:20Z","timestamp":1712175200000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["High\u2010Dose Quadrivalent Influenza Vaccine for Prevention of Cardiovascular and Respiratory Hospitalizations in Older Adults"],"prefix":"10.1111","volume":"18","author":[{"given":"Arto A.","family":"Palmu","sequence":"first","affiliation":[{"name":"Finnish Institute for Health and Welfare (THL)  Tampere Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-6315-0996","authenticated-orcid":false,"given":"Stephanie","family":"Pepin","sequence":"additional","affiliation":[{"name":"Global Clinical Development Sanofi  Marcy L'Etoile France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ritva K.","family":"Syrj\u00e4nen","sequence":"additional","affiliation":[{"name":"Finnish Institute for Health and Welfare (THL)  Tampere Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karine","family":"Mari","sequence":"additional","affiliation":[{"name":"Biostatistics Global Clinical Development Sanofi  Marcy L'Etoile France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tamala","family":"Mallett\u00a0Moore","sequence":"additional","affiliation":[{"name":"Global Pharmacovigilance Sanofi  Swiftwater Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jukka","family":"Jokinen","sequence":"additional","affiliation":[{"name":"Finnish Institute for Health and Welfare (THL)  Helsinki Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heta","family":"Nieminen","sequence":"additional","affiliation":[{"name":"Finnish Institute for Health and Welfare (THL)  Tampere Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Terhi","family":"Kilpi","sequence":"additional","affiliation":[{"name":"Finnish Institute for Health and Welfare (THL)  Helsinki Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandrine I.","family":"Samson","sequence":"additional","affiliation":[{"name":"Global Medical Affairs Sanofi  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iris","family":"De\u00a0Bruijn","sequence":"additional","affiliation":[{"name":"Global Clinical Development Sanofi  Marcy L'Etoile France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,4,3]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.idc.2017.07.005"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jir171"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1702090"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa041747"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cix1144"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/s1473\u20103099(09)70233\u20106"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/acn3.545"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamacardio.2019.0549"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/rmv.2243"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2005.08.105"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1315727"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2015.07.006"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1086\/599790"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2019.01.063"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1080\/14760584.2018.1471989"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2020.09.004"},{"key":"e_1_2_10_18_1","unstructured":"Sanofi Pasteur.Summary of Product Characteristics. 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