{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T09:07:30Z","timestamp":1774602450851,"version":"3.50.1"},"reference-count":19,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2024,4,30]],"date-time":"2024-04-30T00:00:00Z","timestamp":1714435200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"CSL Seqirus, Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Influenza pandemics pose a serious risk to the global population, with the potential for high morbidity and mortality. An adjuvanted H5N1 vaccine (aH5N1) has been approved for prophylaxis against the avian influenza virus H5N1, which is a likely cause of future pandemics. In this phase-III, stratified, randomized, controlled, observer-blind, multicenter study, we evaluated the safety and immunogenicity of aH5N1 in four separate groups of adults: adults 18\u201360 years of age who were healthy or had high-risk medical conditions and older adults \u226561 years of age who were healthy or had high-risk medical conditions. Subjects were randomly assigned to aH5N1 or the comparator, adjuvanted trivalent seasonal influenza vaccine (aTIV). Antibody responses to aH5N1 were increased in all four subgroups and, within each age stratum, largely consistent between healthy subjects and those with medical conditions. Injection-site pain was reported by 66\u201373% of younger and 36\u201342% of older\u2013aH5N1 recipients, and fatigue and myalgia were reported by 22\u201341% of subjects across age and health subgroups. No serious adverse events or deaths were considered related to the study vaccine. In conclusion, aH5N1 increased antibody responses regardless of age or health status and demonstrated a clinically acceptable safety and tolerability profile.<\/jats:p>","DOI":"10.3390\/vaccines12050481","type":"journal-article","created":{"date-parts":[[2024,5,3]],"date-time":"2024-05-03T08:02:22Z","timestamp":1714723342000},"page":"481","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Safety, Tolerability, and Immunogenicity of aH5N1 Vaccine in Adults with and without Underlying Medical Conditions"],"prefix":"10.3390","volume":"12","author":[{"given":"Tomas","family":"Jelinek","sequence":"first","affiliation":[{"name":"Berlin Center for Travel and Tropical Medicine, 10117 Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tino F.","family":"Schwarz","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Klinikum W\u00fcrzburg Mitte, Standort Juliusspital, 97070 W\u00fcrzburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emil","family":"Reisinger","sequence":"additional","affiliation":[{"name":"Medical Faculty, Universit\u00e4tsmedizin Rostock, 18057 Rostock, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Malfertheiner","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology and Infectious Diseases, Otto von Guericke University, 39106 Magdeburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eve","family":"Versage","sequence":"additional","affiliation":[{"name":"Seqirus, Clinical Development, Cambridge, MA 02139, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6493-3393","authenticated-orcid":false,"given":"Esther","family":"Van Twuijver","sequence":"additional","affiliation":[{"name":"Seqirus, Clinical Development, 1105 BJ Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Hohenboken","sequence":"additional","affiliation":[{"name":"Seqirus, Clinical Development, Cambridge, MA 02139, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2024,4,30]]},"reference":[{"key":"ref_1","unstructured":"Centers for Disease Control and Prevention (2023, May 18). 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Note for Guidance on Harmonisation of Requirements for Influenza Vaccines, European Agency for the Evaluation of Medicinal Products."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"1388","DOI":"10.1016\/j.vaccine.2011.12.009","article-title":"Safety and immunogenicity of an MF59\u00ae-adjuvanted A\/H5N1 pre-pandemic influenza vaccine in adults and the elderly","volume":"30","author":"Vesikari","year":"2012","journal-title":"Vaccine"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"ofz107","DOI":"10.1093\/ofid\/ofz107","article-title":"Safety and immunogenicity of MF59-adjuvanted cell culture-derived A\/H5N1 subunit influenza virus vaccine: Dose-finding clinical trials in adults and the elderly","volume":"6","author":"Frey","year":"2019","journal-title":"Open Forum Infect. 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