{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T03:39:34Z","timestamp":1783395574669,"version":"3.54.6"},"reference-count":30,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2024,12,19]],"date-time":"2024-12-19T00:00:00Z","timestamp":1734566400000},"content-version":"vor","delay-in-days":18,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000016","name":"U.S. Department of Health and Human Services","doi-asserted-by":"publisher","award":["HHSO100201600004I"],"award-info":[{"award-number":["HHSO100201600004I"]}],"id":[{"id":"10.13039\/100000016","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004330","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":[[2024,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Influenza A\/Hong Kong\/125\/2017 (H7N9) virus poses a pandemic risk owing to its evolving nature. This study evaluated the immunogenicity and safety of an AS03\u2010adjuvanted H7N9 vaccine in adults (18\u201364\u2009years [younger] and \u226565\u2009years [older]).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Participants (younger, <jats:italic>n<\/jats:italic>\u2009=\u2009418; older, <jats:italic>n<\/jats:italic>\u2009=\u2009420) were randomized to receive one of six adjuvanted vaccines (hemagglutinin [1.9\u2009\u03bcg, 3.75\u2009\u03bcg, and 7.5\u2009\u03bcg] with AS03<jats:sub>A<\/jats:sub> or AS03<jats:sub>B<\/jats:sub>) or placebo. The co\u2010primary objectives were to determine whether the adjuvanted vaccines elicit an immune response against the vaccine\u2010homologous virus 21\u2009days after the second vaccine dose and to evaluate the safety of the vaccines.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>H7N9 AS03\u2010adjuvanted vaccines at various doses showed a humoral immune response but failed to meet CBER immunogenicity criteria. However, a trend of increased immune responses was observed with the AS03<jats:sub>A<\/jats:sub> adjuvant versus the AS03<jats:sub>B<\/jats:sub> adjuvant, particularly in older adults. In both age groups, injection site pain and fatigue occurred more frequently with adjuvanted vaccines. No reported serious adverse events were vaccine\u2010related.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This study did not achieve its primary objective at any dose level. The modest immune response to AS03\u2010adjuvanted vaccines, consistent with other studies using similar antigens, highlights the need for continued research for H7N9 pandemic preparedness.<\/jats:p><jats:p><jats:bold>Trial Registration:<\/jats:bold> NCT04789577 [<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link>]<\/jats:p><\/jats:sec>","DOI":"10.1111\/irv.70020","type":"journal-article","created":{"date-parts":[[2024,12,20]],"date-time":"2024-12-20T03:41:27Z","timestamp":1734666087000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Immunogenicity and Safety of AS03\u2010Adjuvanted H7N9 Influenza Vaccine in Adults (18\u201364 and \u226565\u2009Years): A Phase 1\/2, Randomized, Placebo\u2010Controlled Trial"],"prefix":"10.1111","volume":"18","author":[{"given":"Andrew","family":"Hastie","sequence":"first","affiliation":[{"name":"GSK  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanya","family":"Clarke","sequence":"additional","affiliation":[{"name":"GSK  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Germain","sequence":"additional","affiliation":[{"name":"GSK  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thierry","family":"Ollinger","sequence":"additional","affiliation":[{"name":"GSK  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Lese","sequence":"additional","affiliation":[{"name":"GSK  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vinay","family":"Gupta","sequence":"additional","affiliation":[{"name":"GSK  Bangalore India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,12,19]]},"reference":[{"key":"e_1_2_14_2_1","unstructured":"Centers for Disease Control and Prevention.Types of Influenza Viruses. accessed November 27 2023 http:\/\/www.cdc.gov\/flu\/about\/viruses\/types.htm."},{"key":"e_1_2_14_3_1","unstructured":"Centers for Disease Control and Prevention.Influenza Type A Viruses. accessed November 27 2023 http:\/\/www.cdc.gov\/flu\/avianflu\/influenza\u2010a\u2010virus\u2010subtypes.htm."},{"key":"e_1_2_14_4_1","doi-asserted-by":"publisher","DOI":"10.3201\/eid2308.170600"},{"key":"e_1_2_14_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/cr.2017.129"},{"key":"e_1_2_14_6_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.1240532"},{"key":"e_1_2_14_7_1","doi-asserted-by":"publisher","DOI":"10.1080\/22221751.2022.2155072"},{"key":"e_1_2_14_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chom.2018.08.006"},{"key":"e_1_2_14_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11427-018-9365-7"},{"key":"e_1_2_14_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/MCP.0000000000000047"},{"key":"e_1_2_14_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiw414"},{"key":"e_1_2_14_12_1","doi-asserted-by":"publisher","DOI":"10.1128\/JVI.02044-13"},{"key":"e_1_2_14_13_1","doi-asserted-by":"publisher","DOI":"10.1128\/JVI.02765-13"},{"key":"e_1_2_14_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jit474"},{"key":"e_1_2_14_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2009.01.116"},{"key":"e_1_2_14_16_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0049704"},{"key":"e_1_2_14_17_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0087962"},{"key":"e_1_2_14_18_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc1313186"},{"key":"e_1_2_14_19_1","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.3008761"},{"key":"e_1_2_14_20_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.12854"},{"key":"e_1_2_14_21_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2015.7916"},{"key":"e_1_2_14_22_1","first-page":"68","article-title":"Immunosenescence and Challenges of Vaccination Against Influenza in the Aging Population","volume":"3","author":"Reber A. J.","year":"2012","journal-title":"Aging and Disease"},{"key":"e_1_2_14_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2017.02.057"},{"key":"e_1_2_14_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.virol.2017.05.010"},{"key":"e_1_2_14_25_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiu359"},{"key":"e_1_2_14_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2011.04.011"},{"key":"e_1_2_14_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2022.03.055"},{"key":"e_1_2_14_28_1","doi-asserted-by":"publisher","DOI":"10.1128\/JVI.00216-20"},{"key":"e_1_2_14_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)61297-5"},{"key":"e_1_2_14_30_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jis427"},{"key":"e_1_2_14_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jfma.2011.02.006"}],"container-title":["Influenza and Other Respiratory Viruses"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/irv.70020","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,2]],"date-time":"2025-03-02T11:58:08Z","timestamp":1740916688000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/irv.70020"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12]]},"references-count":30,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2024,12]]}},"alternative-id":["10.1111\/irv.70020"],"URL":"https:\/\/doi.org\/10.1111\/irv.70020","archive":["Portico"],"relation":{},"ISSN":["1750-2640","1750-2659"],"issn-type":[{"value":"1750-2640","type":"print"},{"value":"1750-2659","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,12]]},"assertion":[{"value":"2024-03-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-10-01","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-12-19","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70020"}}