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Immunological investigations to understand the outcome of the phase III efficacy studies of the Sanofi Pasteur dengue vaccine (Abstract no. 553). American Society of Tropical Medicine and Hygiene\u201464th Annual Meeting; 2015 October 25\u201329; Philadelphia, PA."},{"key":"ref50","unstructured":"World Health Organisation. Dengue vaccine research 2016 [30 April 2016]. Available from: <ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.who.int\/immunization\/research\/development\/dengue_vaccines\/en\/\" xlink:type=\"simple\">http:\/\/www.who.int\/immunization\/research\/development\/dengue_vaccines\/en\/<\/ext-link>."}],"container-title":["PLOS Neglected Tropical Diseases"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/dx.plos.org\/10.1371\/journal.pntd.0004821","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,5,16]],"date-time":"2020-05-16T21:18:47Z","timestamp":1589663927000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pntd.0004821"}},"subtitle":[],"editor":[{"given":"Amy C","family":"Morrison","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2016,7,14]]},"references-count":50,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2016,7,14]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pntd.0004821","relation":{},"ISSN":["1935-2735"],"issn-type":[{"value":"1935-2735","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,7,14]]}}}