{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,6]],"date-time":"2026-02-06T22:58:59Z","timestamp":1770418739250,"version":"3.49.0"},"reference-count":22,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2020,6,24]],"date-time":"2020-06-24T00:00:00Z","timestamp":1592956800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Influenza Resp Viruses"],"published-print":{"date-parts":[[2020,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>We have developed an AS03\u2010adjuvanted H5N1 influenza vaccine produced in an EB66<jats:sup>\u00ae<\/jats:sup> cell culture platform (KD\u2010295).<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>In accordance with Japanese guidelines for development of pandemic prototype vaccines, the phase II study was conducted in a double\u2010blind, randomized, parallel\u2010group comparison study and the phase III study was conducted in an open\u2010label, non\u2010randomized, uncontrolled study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Healthy adult volunteers aged 20\u00a0\u2010\u00a064\u00a0years enrolled in the phase II and III studies (N\u00a0=\u00a0248 and N\u00a0=\u00a0369) received KD\u2010295 intramuscularly twice with a 21\u2010day interval. After administration, immune response and adverse events were evaluated. In the phase II study, four different vaccine formulations were compared: MA (3.75\u00a0\u03bcg hemagglutinin [HA] antigen\u00a0+\u00a0AS03 adjuvant system), MB (3.75\u00a0\u03bcg\u00a0HA\u00a0+\u00a01\/2AS03), HA (7.5\u00a0\u03bcg\u00a0HA\u00a0+\u00a0AS03), and HB (7.5\u00a0\u03bcg\u00a0HA\u00a0+\u00a01\/2AS03). In the phase III study, the MA formulation was further evaluated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the phase II study, all four vaccine formulations were well\u2010tolerated and no SAE related to vaccination were observed. The MA formulation was slightly more immunogenic and less reactogenic among the vaccine formulations. Therefore, the MA formulation was selected for the phase III study, and it was well\u2010tolerated and no serious adverse drug reactions were observed. The vaccine fulfilled the three immunogenicity criteria described in the Japanese guidelines.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>These data indicate that the MA formulation of KD\u2010295 was well\u2010tolerated and highly immunogenic and it can be considered a useful pandemic and pre\u2010pandemic influenza vaccine.<\/jats:p><\/jats:sec>","DOI":"10.1111\/irv.12755","type":"journal-article","created":{"date-parts":[[2020,6,24]],"date-time":"2020-06-24T20:22:55Z","timestamp":1593030175000},"page":"551-563","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Clinical phase II and III studies of an AS03\u2010adjuvanted H5N1 influenza vaccine produced in an EB66<sup>\u00ae<\/sup> cell culture platform"],"prefix":"10.1111","volume":"14","author":[{"given":"Masafumi","family":"Endo","sequence":"first","affiliation":[{"name":"KM Biologics Co., Ltd. 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