{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,28]],"date-time":"2025-10-28T14:56:45Z","timestamp":1761663405208},"reference-count":23,"publisher":"Elsevier BV","issue":"45","license":[{"start":{"date-parts":[[2015,11,1]],"date-time":"2015-11-01T00:00:00Z","timestamp":1446336000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"}],"content-domain":{"domain":["clinicalkey.jp","clinicalkey.com","clinicalkey.es","clinicalkey.com.au","clinicalkey.fr","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Vaccine"],"published-print":{"date-parts":[[2015,11]]},"DOI":"10.1016\/j.vaccine.2015.09.022","type":"journal-article","created":{"date-parts":[[2015,9,26]],"date-time":"2015-09-26T07:17:34Z","timestamp":1443251854000},"page":"6078-6084","update-policy":"http:\/\/dx.doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":11,"title":["A clinical phase I study of an EB66 cell-derived H5N1 pandemic vaccine adjuvanted with AS03"],"prefix":"10.1016","volume":"33","author":[{"given":"Takeshi","family":"Naruse","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tadashi","family":"Fukuda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tetsuro","family":"Tanabe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Munetaka","family":"Ichikawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshiaki","family":"Oda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shinji","family":"Tochihara","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuhiko","family":"Kimachi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoichiro","family":"Kino","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kohji","family":"Ueda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.vaccine.2015.09.022_bib0120","series-title":"WHO global influenza preparedness plan: The role of WHO and recommendations for national measures before and during pandemics","author":"World Health Organization","year":"2005"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0125","series-title":"The White Paper on Annual Health, Labor and Welfare \u2013 Social Security \u2013 2012","article-title":"Chapter 4 Ensuring healthful and safe living: Part 2 Responses to current political challenges","author":"Ministry of Health. Labor and Welfare","year":"2012"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0130","doi-asserted-by":"crossref","first-page":"e1665","DOI":"10.1371\/journal.pone.0001665","article-title":"Broad Clade 2 cross-reactive immunity induced by an adjuvanted clade 1 rH5N1 pandemic influenza vaccine","volume":"3","author":"Leroux-Roels","year":"2008","journal-title":"PLoS ONE"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0135","doi-asserted-by":"crossref","first-page":"580","DOI":"10.1016\/S0140-6736(07)61297-5","article-title":"Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial","volume":"370","author":"Leroux-Roels","year":"2007","journal-title":"Lancet"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0140","doi-asserted-by":"crossref","first-page":"1644","DOI":"10.1086\/652701","article-title":"Safety and cross-reactive immunogenicity of candidate AS03-adjuvanted prepandemic H5N1 influenza vaccines: a randomized controlled phase 1\/2 trial in adults","volume":"201","author":"Langley","year":"2010","journal-title":"J Infect Dis"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0145","first-page":"419","article-title":"The avian EB66\u00ae cell line, application to vaccines, and therapeutic protein production","volume":"64","author":"Brown","year":"2010","journal-title":"PDA J Pharm Sci Technol"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0150","doi-asserted-by":"crossref","first-page":"1870","DOI":"10.1016\/j.vaccine.2013.01.042","article-title":"Optimal approaches to data collection and analysis of potential immune mediated disorders in clinical trials of new vaccines","volume":"31","author":"Tavares Da Silva","year":"2013","journal-title":"Vaccine"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0155","doi-asserted-by":"crossref","first-page":"81","DOI":"10.1111\/j.1348-0421.2009.00191.x","article-title":"Immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1, NIBRG-14) vaccine administered by intramuscular or subcutaneous injection","volume":"54","author":"Ikeno","year":"2010","journal-title":"Microbiol Immunol"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0160","doi-asserted-by":"crossref","first-page":"261","DOI":"10.1111\/j.1750-2659.2008.00066.x","article-title":"Characterization of a whole, inactivated influenza (H5N1) vaccine","volume":"2","author":"Tada","year":"2008","journal-title":"Influenza Other Respir Viruses"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0165","doi-asserted-by":"crossref","first-page":"279","DOI":"10.2165\/00063030-200822050-00001","article-title":"Prepandemic influenza vaccine H5N1 (split virion, inactivated, adjuvanted) [Prepandrix\u2122]: a review of its use as an active immunization against influenza A subtype H5N1 virus","volume":"22","author":"Carter","year":"2008","journal-title":"BioDrugs"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0170","doi-asserted-by":"crossref","first-page":"840","DOI":"10.1016\/j.vaccine.2009.10.019","article-title":"Dose ranging of adjuvant and antigen in a cell culture H5N1 influenza vaccine: safety and immunogenicity of a phase 1\/2 clinical trial","volume":"28","author":"Keitel","year":"2010","journal-title":"Vaccine"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0175","doi-asserted-by":"crossref","first-page":"2573","DOI":"10.1056\/NEJMoa073121","article-title":"A clinical trial of a whole-virus H5N1 vaccine derived from cell culture","volume":"358","author":"Ehrlich","year":"2008","journal-title":"N Engl J Med"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0180","doi-asserted-by":"crossref","first-page":"401","DOI":"10.1586\/erv.09.15","article-title":"Current status and progress of prepandemic and pandemic influenza vaccine development","volume":"8","author":"Leroux-Roels","year":"2009","journal-title":"Expert Rev Vaccines"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0185","series-title":"Module 2: common technical document summaries","article-title":"Clinical overview: adsorbed influenza vaccine (H5N1) SEIKEN 1mL","author":"Pharmaceuticals and Medical Devices Agency website. Tokyo, Japan: Denka Seiken Co., Ltd","year":"2013"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0190","series-title":"Narcolepsy in association with pandemic influenza vaccination: a multi-country European epidemiological investigation: technical report","author":"European Centre for Disease Prevention and Control","year":"2012"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0195","doi-asserted-by":"crossref","first-page":"e33536","DOI":"10.1371\/journal.pone.0033536","article-title":"AS03-adjuvanted AH1N1 vaccine associated with an abrupt increase in the incidence of childhood narcolepsy in Finland","volume":"7","author":"Nohynek","year":"2012","journal-title":"PLoS ONE"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0200","series-title":"Occurrence of narcolepsy with cataplexy among children and adolescents in relation to the H1N1 pandemic and Pandemrix vaccinations: Results of a case inventory study by the MPA in Sweden during 2009\u20132010","author":"Medical Products Agency","year":"2011"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0205","series-title":"Investigation of an increase in the incidence of narcolepsy in children and adolescents in 2009 and 2010: final report of National Narcolepsy Study Steering Committee","author":"National Narcolepsy Study Steering Committee","year":"2012"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0210","series-title":"Etude NarcoFlu-VF (NarcoFlu VAESCO-France): Version 2.0. 2012","author":"Centre Hospitalier et Universitaire de Bordeaux Inserm Universite Bordeaux Segalen","year":"2012"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0215","doi-asserted-by":"crossref","first-page":"f794","DOI":"10.1136\/bmj.f794","article-title":"Risk of narcolepsy in children and young people receiving AS03-adjuvanted pandemic A\/H1N1 2009 influenza vaccine: retrospective analysis","volume":"346","author":"Miller","year":"2013","journal-title":"BMJ"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0220","doi-asserted-by":"crossref","first-page":"1315","DOI":"10.1212\/WNL.0b013e31828ab26f","article-title":"Increased childhood incidence of narcolepsy in western Sweden after H1N1 influenza vaccination","volume":"80","author":"Szak\u00e1cs","year":"2013","journal-title":"Neurology"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0225","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1093\/cid\/ciu948","article-title":"Allergic reactions after egg-free recombinant influenza vaccine: reports to the US vaccine adverse event reporting system","volume":"60","author":"Woo","year":"2015","journal-title":"Clin Infect Dis"},{"key":"10.1016\/j.vaccine.2015.09.022_bib0230","doi-asserted-by":"crossref","first-page":"443","DOI":"10.1007\/s10875-010-9490-6","article-title":"H5N1influenza vaccine formulated with AS03A induces strong cross-reactive and polyfunctional CD4 T-cell responses","volume":"31","author":"Moris","year":"2011","journal-title":"J Clin Immunol"}],"container-title":["Vaccine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0264410X15012864?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0264410X15012864?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2018,9,19]],"date-time":"2018-09-19T05:27:59Z","timestamp":1537334879000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0264410X15012864"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,11]]},"references-count":23,"journal-issue":{"issue":"45","published-print":{"date-parts":[[2015,11]]}},"alternative-id":["S0264410X15012864"],"URL":"https:\/\/doi.org\/10.1016\/j.vaccine.2015.09.022","relation":{},"ISSN":["0264-410X"],"issn-type":[{"value":"0264-410X","type":"print"}],"subject":[],"published":{"date-parts":[[2015,11]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"A clinical phase I study of an EB66 cell-derived H5N1 pandemic vaccine adjuvanted with AS03","name":"articletitle","label":"Article Title"},{"value":"Vaccine","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.vaccine.2015.09.022","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"Copyright \u00a9 2015 Elsevier Ltd. All rights reserved.","name":"copyright","label":"Copyright"}]}}