{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,30]],"date-time":"2025-12-30T11:12:56Z","timestamp":1767093176412,"version":"3.40.5"},"reference-count":21,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2020,3,27]],"date-time":"2020-03-27T00:00:00Z","timestamp":1585267200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmaceutical Statistics"],"published-print":{"date-parts":[[2020,9]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>In recent years, many vaccines have been developed for the prevention of a variety of diseases. Although the primary objective of vaccination is to prevent disease, vaccination can also reduce the severity of disease in those individuals who develop breakthrough disease. Observations of apparent mitigation of breakthrough disease in vaccine recipients have been reported for a number of vaccine\u2010preventable diseases such as Herpes Zoster, Influenza, Rotavirus, and Pertussis. The burden\u2010of\u2010illness (BOI) score was developed to incorporate the incidence of disease as well as the severity and duration of disease. A severity\u2010of\u2010illness score <jats:italic>S<\/jats:italic>\u2009&gt;\u20090 is assigned to individuals who develop disease and a score of 0 is assigned to uninfected individuals. In this article, we derive the vaccine efficacy statistic (which is the standard statistic for presenting efficacy outcomes in vaccine clinical trials) based on BOI scores, and we extend the method to adjust for baseline covariates. Also, we illustrate it with data from a clinical trial in which the efficacy of a Herpes Zoster vaccine was evaluated.<\/jats:p>","DOI":"10.1002\/pst.2020","type":"journal-article","created":{"date-parts":[[2020,3,27]],"date-time":"2020-03-27T08:47:25Z","timestamp":1585298845000},"page":"636-645","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["<scp>Burden\u2010of\u2010illness<\/scp> vaccine efficacy"],"prefix":"10.1002","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4805-5118","authenticated-orcid":false,"given":"Andrea","family":"Callegaro","sequence":"first","affiliation":[{"name":"GSK Vaccines, Rue de l'Institut  Rixensart Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Desmond","family":"Curran","sequence":"additional","affiliation":[{"name":"GSK Vaccines, Avenue Fleming  Wavre Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sean","family":"Matthews","sequence":"additional","affiliation":[{"name":"GSK Vaccines, Avenue Fleming  Wavre Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,3,27]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780131803"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1541-0420.2008.01131.x"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19991030)18:20<2749::AID-SIM195>3.0.CO;2-C"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.790"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1191\/0962280202sm289ra"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1541-0420.2005.00516.x"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1037\/h0037350"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1177\/0962280214532911"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.0006-341X.2002.00021.x"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/1541-0420.00063"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.1394"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa051016"},{"key":"e_1_2_12_14_1","unstructured":"European Medicines Agency. Zostavax: summary of product characteristics [online]. Available from URL:http:\/\/www.emea.europa.eu\/humandocs\/PDFs\/EPAR\/zostavax\/H-674-PI-en.pdf"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bbmt.2019.07.036"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpain.2004.06.001"},{"key":"e_1_2_12_17_1","unstructured":"YehST. Using trapezoidal rule for the area under a curve calculation. Proceedings of the 27th Annual SAS User Group International (SUGI 27) Orlando FL;2002."},{"key":"e_1_2_12_18_1","first-page":"1","article-title":"Efficacy and safety of an Adjuvanted herpes zoster subunit vaccine in autologous hematopoietic stem cell transplant recipients 18\u2009years of age or older: first results of the phase 3 randomized, placebo\u2010controlled Zoe\u2010HSCT clinical trial","volume":"1","author":"Serna L","year":"2018","journal-title":"ASBMT"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1093\/gerona\/gly150"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cir959"},{"key":"e_1_2_12_21_1","first-page":"133","article-title":"Study in active immunization against pertussis","volume":"38","author":"Kendrick P","year":"1939","journal-title":"Am J Hygeine Sect B"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.inf.0000197565.45345.4e"}],"container-title":["Pharmaceutical Statistics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpst.2020","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pst.2020","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/pst.2020","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pst.2020","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,25]],"date-time":"2023-08-25T13:35:56Z","timestamp":1692970556000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pst.2020"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,3,27]]},"references-count":21,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2020,9]]}},"alternative-id":["10.1002\/pst.2020"],"URL":"https:\/\/doi.org\/10.1002\/pst.2020","archive":["Portico"],"relation":{},"ISSN":["1539-1604","1539-1612"],"issn-type":[{"type":"print","value":"1539-1604"},{"type":"electronic","value":"1539-1612"}],"subject":[],"published":{"date-parts":[[2020,3,27]]},"assertion":[{"value":"2018-11-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-03-02","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-03-27","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}