{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T08:17:31Z","timestamp":1790324251003,"version":"4.1.0"},"reference-count":32,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2016]]},"abstract":"<jats:sec>\n                    <jats:title\/>\n                    <jats:p>Each novel vaccine candidate needs to be evaluated for safety, immunogenicity, and protective efficacy in humans before it is licensed for use. After initial safety evaluation in healthy adults, each vaccine candidate follows a unique development path. This article on clinical development gives an overview on the development path based on the expectations of various guidelines issued by the World Health Organization (WHO), the European Medicines Agency (EMA), and the United States Food and Drug Administration (USFDA). The manuscript describes the objectives, study populations, study designs, study site, and outcome(s) of each phase (Phase I-III) of a clinical trial. Examples from the clinical development of a malaria vaccine candidate, a rotavirus vaccine, and two vaccines approved for human papillomavirus (HPV) have also been discussed. The article also tabulates relevant guidelines, which can be referred to while drafting the development path of a novel vaccine candidate.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.4103\/0022-3859.173187","type":"journal-article","created":{"date-parts":[[2016,1,5]],"date-time":"2016-01-05T04:36:01Z","timestamp":1451968561000},"page":"4-11","source":"Crossref","is-referenced-by-count":103,"title":["The clinical development process for a novel preventive vaccine"],"prefix":"10.4103","volume":"62","author":[{"given":"K","family":"Singh","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S","family":"Mehta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"R4-2-20240205","doi-asserted-by":"crossref","first-page":"89","DOI":"10.1191\/0962280204sm356ra","article-title":"Endpoints in vaccine trials","volume":"13","author":"Hudgens","year":"2004","journal-title":"Stat Methods Med Res"},{"key":"R5-2-20240205","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1385\/MB:17:1:43","article-title":"Vaccine trials","volume":"17","author":"Farrington","year":"2001","journal-title":"Mol Biotechnol"},{"key":"R7-2-20240205","doi-asserted-by":"crossref","first-page":"589","DOI":"10.1586\/erv.11.57","article-title":"The RTS,S vaccine candidate for malaria","volume":"10","author":"Regules","year":"2011","journal-title":"Expert Rev Vaccines"},{"key":"R8-2-20240205","doi-asserted-by":"crossref","first-page":"4880","DOI":"10.1016\/j.vaccine.2010.05.033","article-title":"The RTS,S malaria vaccine","volume":"28","author":"Casares","year":"2010","journal-title":"Vaccine"},{"key":"R9-2-20240205","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1586\/14760584.6.1.11","article-title":"RotarixTM (RIX4414): An oral human rotavirus vaccine","volume":"6","author":"O'Ryan","year":"2007","journal-title":"Expert Rev Vaccines"},{"key":"R10-2-20240205","doi-asserted-by":"crossref","first-page":"75","DOI":"10.2165\/0148581-200911010-00025","article-title":"Rotavirus vaccine RIX4414 (Rotarix): A review of its use in the prevention of rotavirus gastroenteritis","volume":"11","author":"McCormack","year":"2009","journal-title":"Paediatr Drugs"},{"key":"R13-2-20240205","doi-asserted-by":"crossref","first-page":"469","DOI":"10.1503\/cmaj.070948","article-title":"Prophylactic vaccination against human papillomavirus infection and disease in women: A systematic review of randomized clinical trials","volume":"177","author":"Rambout","year":"2007","journal-title":"CMAJ"},{"key":"R14-2-20240205","doi-asserted-by":"crossref","first-page":"K53","DOI":"10.1016\/j.vaccine.2008.06.002","article-title":"An update of prophylactic human papillomavirus L1 Virus-like particle vaccine clinical trial results","volume":"26","author":"Schiller","year":"2008","journal-title":"Vaccine"},{"key":"R15-2-20240205","doi-asserted-by":"crossref","first-page":"e3960","DOI":"10.1371\/journal.pone.0003960","article-title":"Safety and immunogenicity of a recombinant Plasmodium falciparum AMA1 malaria vaccine adjuvanted with Alhydrogel, Montanide ISA 720 or ASO2","volume":"3","author":"Roestenberg","year":"2008","journal-title":"PLoS One"},{"key":"R18-2-20240205","doi-asserted-by":"crossref","first-page":"5041","DOI":"10.1016\/j.vaccine.2013.08.087","article-title":"Assessment of causality of individual adverse events following immunization (AEFI): A WHO tool for global use","volume":"31","author":"Tozzi","year":"2013","journal-title":"Vaccine"},{"key":"R19-2-20240205","doi-asserted-by":"crossref","first-page":"237","DOI":"10.1097\/QCO.0b013e32811ebfb0","article-title":"Adverse events following immunization: Perception and evidence","volume":"20","author":"Bonhoeffer","year":"2007","journal-title":"Curr Opin Infect Dis"},{"key":"R22-2-20240205","doi-asserted-by":"crossref","first-page":"2282","DOI":"10.1016\/j.vaccine.2008.11.036","article-title":"Brighton Collaboration Methods Working Group. 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