{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,17]],"date-time":"2026-01-17T18:56:34Z","timestamp":1768676194734,"version":"3.49.0"},"reference-count":17,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2024,2,13]],"date-time":"2024-02-13T00:00:00Z","timestamp":1707782400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["R01 AI 136947"],"award-info":[{"award-number":["R01 AI 136947"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["R01 AI 139761"],"award-info":[{"award-number":["R01 AI 139761"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["R37 AI 29168"],"award-info":[{"award-number":["R37 AI 29168"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Statistics in Medicine"],"published-print":{"date-parts":[[2024,4,15]]},"abstract":"<jats:p>Both individually and cluster randomized study designs have been used for vaccine trials to assess the effects of vaccine on reducing the risk of disease or infection. The choice between individually and cluster randomized designs is often driven by the target estimand of interest (eg, direct versus total), statistical power, and, importantly, logistic feasibility. To combat emerging infectious disease threats, especially when the number of events from one single trial may not be adequate to obtain vaccine effect estimates with a desired level of precision, it may be necessary to combine information across multiple trials. In this article, we propose a model formulation to estimate the direct, indirect, total, and overall vaccine effects combining data from trials with two types of study designs: individual\u2010randomization and cluster\u2010randomization, based on a Cox proportional hazards model, where the hazard of infection depends on both vaccine status of the individual as well as the vaccine status of the other individuals in the same cluster. We illustrate the use of the proposed model and assess the potential efficiency gain from combining data from multiple trials, compared to using data from each individual trial alone, through two simulation studies, one of which is designed based on a cholera vaccine trial previously carried out in Matlab, Bangladesh.<\/jats:p>","DOI":"10.1002\/sim.10030","type":"journal-article","created":{"date-parts":[[2024,2,13]],"date-time":"2024-02-13T09:30:15Z","timestamp":1707816615000},"page":"1627-1639","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Methods for the estimation of direct and indirect vaccination effects by combining data from individual\u2010 and cluster\u2010randomized trials"],"prefix":"10.1002","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5007-193X","authenticated-orcid":false,"given":"Rui","family":"Wang","sequence":"first","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School  Boston Massachusetts USA"},{"name":"Department of Biostatistics Harvard T. H. Chan School of Public Health  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mengqi","family":"Cen","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yunda","family":"Huang","sequence":"additional","affiliation":[{"name":"Vaccine and Infectious Disease and Public Health Sciences Divisions Fred Hutchinson Cancer Research Center  Seattle Washington USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"George","family":"Qian","sequence":"additional","affiliation":[{"name":"Centre for Mathematical Modelling of Infectious Diseases London School of Hygiene &amp; Tropical Medicine  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natalie E.","family":"Dean","sequence":"additional","affiliation":[{"name":"Department of Biostatistics &amp; Bioinformatics Emory University  Atlanta Georgia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2364-5253","authenticated-orcid":false,"given":"Susan S.","family":"Ellenberg","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Epidemiology and Informatics University of Pennsylvania  Philadelphia Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0420-5068","authenticated-orcid":false,"given":"Thomas R.","family":"Fleming","sequence":"additional","affiliation":[{"name":"Department of Biostatistics University of Washington  Seattle Washington USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7320-4755","authenticated-orcid":false,"given":"Wenbin","family":"Lu","sequence":"additional","affiliation":[{"name":"Department of Statistics North Carolina State University  Raleigh North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2780-9382","authenticated-orcid":false,"given":"Ira M.","family":"Longini","sequence":"additional","affiliation":[{"name":"Department of Biostatistics University of Florida  Gainesville Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,2,13]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/17407745221110880"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)61117-5"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2110345"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-0-387-68636-3"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-94-015-7983-4_14"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1177\/003591571500801433"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(86)91944-6"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/65.1.141"},{"key":"e_1_2_7_10_1","volume-title":"Copula: Multivariate Dependence with Copulas","author":"Hofert M","year":"2023"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0040336"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1198\/016214508000000292"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/biom.13782"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.0006-341X.2001.01198.x"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.2157"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/bimj.202200113"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciab226"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/biom.13509"}],"container-title":["Statistics in Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/sim.10030","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,3,16]],"date-time":"2024-03-16T07:03:29Z","timestamp":1710572609000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/sim.10030"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,13]]},"references-count":17,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2024,4,15]]}},"alternative-id":["10.1002\/sim.10030"],"URL":"https:\/\/doi.org\/10.1002\/sim.10030","archive":["Portico"],"relation":{},"ISSN":["0277-6715","1097-0258"],"issn-type":[{"value":"0277-6715","type":"print"},{"value":"1097-0258","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2,13]]},"assertion":[{"value":"2023-03-20","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-01-22","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-02-13","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}