{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T19:40:42Z","timestamp":1777578042438,"version":"3.51.4"},"reference-count":35,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2018,7,26]],"date-time":"2018-07-26T00:00:00Z","timestamp":1532563200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["5 R21 HD080214"],"award-info":[{"award-number":["5 R21 HD080214"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007327","name":"Gillings School of Public Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007327","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005539","name":"Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005539","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100011082","name":"School of Medicine, University of North Carolina at Chapel Hill","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011082","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Paediatric Perinatal Epid"],"published-print":{"date-parts":[[2018,9]]},"abstract":"Abstract<\/jats:title>Background<\/jats:title>The aim of this study was to evaluate the short\u2010term risk of adverse events associated with rotavirus vaccine (RV<\/jats:styled-content>) in infants, overall and by vaccine formulation (three\u2010dose pentavalent, RV<\/jats:styled-content>5; two\u2010dose monovalent, RV<\/jats:styled-content>1).<\/jats:p><\/jats:sec>Methods<\/jats:title>We identified US<\/jats:styled-content> newborns with commercial insurance during 2006\u20102014 receiving a diphtheria\u2010tetanus\u2010pertussis vaccine (DT<\/jats:styled-content>aP) dose and assessed if RV<\/jats:styled-content> was administered concurrently. We followed infants for 30\u00a0days after each dose for diagnoses of intussusception, other gastrointestinal events, seizures, Kawasaki disease, thrombocytopenia, otitis media, all\u2010cause emergency department visits, and all\u2010cause hospitalisations. We estimated adjusted hazard ratios (HR<\/jats:styled-content>) and 95% confidence intervals (CI<\/jats:styled-content>) with multivariable Cox proportional hazards models comparing: (a) those receiving DTaP+RV vs those receiving DT<\/jats:styled-content>aP alone; and (b) RV<\/jats:styled-content>5 vs RV<\/jats:styled-content>1. Analyses were performed separately within DT<\/jats:styled-content>aP doses and then meta\u2010analysed across doses.<\/jats:p><\/jats:sec>Results<\/jats:title>We identified 1\u00a0031\u00a0431 first DT<\/jats:styled-content>aP doses, 821\u00a0833\u00a0second doses, and 615\u00a0293 third doses; 79.2% had a concurrent RV<\/jats:styled-content>, 94.1% of which were RV<\/jats:styled-content>5. Absolute risks of serious outcomes were very low. Compared to infants who received DT<\/jats:styled-content>aP alone, infants who received RV+DTaP did not experience consistently increased risk of intussusception (hazard ratio [HR<\/jats:styled-content>] 1.13, 95% confidence interval [CI<\/jats:styled-content>] 0.68, 1.88) or any other outcome except for otitis media after dose 2: HR<\/jats:styled-content> 1.11, 95% CI<\/jats:styled-content> 1.08, 1.15. This increased otitis media risk was not as pronounced in RV<\/jats:styled-content>5 when comparing RV<\/jats:styled-content>5 to RV<\/jats:styled-content>1; HR<\/jats:styled-content> 0.92, 95% CI<\/jats:styled-content> 0.89, 0.95.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>These data were not consistent with an increased risk of intussusception or other adverse events following vaccination with RV<\/jats:styled-content>, except potentially for a small increased risk of otitis media, particularly in RV<\/jats:styled-content>1.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ppe.12496","type":"journal-article","created":{"date-parts":[[2018,7,26]],"date-time":"2018-07-26T19:40:05Z","timestamp":1532634005000},"page":"448-457","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Rotavirus vaccination and short\u2010term risk of adverse events in US<\/scp> infants"],"prefix":"10.1111","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0994-5820","authenticated-orcid":false,"given":"J. Bradley","family":"Layton","sequence":"first","affiliation":[{"name":"Department of Epidemiology Gillings School of Global Public Health University of North Carolina at Chapel Hill Research Triangle Park North Carolina"},{"name":"RTI Health Solutions Research Triangle Park North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne M.","family":"Butler","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases Washington University School of Medicine in St. Louis St. Louis Missouri"},{"name":"Division of Public Health Sciences Department of Surgery Washington University School of Medicine St. Louis Missouri"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine A.","family":"Panozzo","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School Boston Massachusetts"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. Alan","family":"Brookhart","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Gillings School of Global Public Health University of North Carolina at Chapel Hill Research Triangle Park North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,7,26]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.inf.0000215234.91997.21"},{"key":"e_1_2_8_3_1","first-page":"1","article-title":"Prevention of rotavirus gastroenteritis among infants and children: recommendations of the Advisory Committee on Immunization Practices (ACIP)","volume":"58","author":"Cortese MM","year":"2009","journal-title":"MMWR Recomm Rep"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwu001"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0073825"},{"key":"e_1_2_8_6_1","unstructured":"HealthyPeople.gov.Immunization and infectious diseases. US Office of Disease Prevention & Health Promotion;2017.https:\/\/www.healthypeople.gov\/2020\/topics-objectives\/topic\/immunization-and-infectious-diseases\/objectives. Accessed June 22 2017."},{"key":"e_1_2_8_7_1","first-page":"577","article-title":"C, Prevention. Intussusception among recipients of rotavirus vaccine\u2013United States, 1998\u20101999","volume":"48","author":"Centers for Disease","year":"1999","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2011.01.088"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1012952"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cit520"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1311738"},{"key":"e_1_2_8_12_1","first-page":"598","article-title":"Risk of intussusception following administration of a pentavalent rotavirus vaccine in US Infants","volume":"307","author":"Shu IM","year":"2012","journal-title":"JAMA J Am Med Assoc"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1303164"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1440-1754.2008.01434.x"},{"key":"e_1_2_8_15_1","doi-asserted-by":"crossref","first-page":"674","DOI":"10.47102\/annals-acadmedsg.V35N10p674","article-title":"The epidemiology of paediatric intussusception in Singapore: 1997 to 2004","volume":"35","author":"Boudville IC","year":"2006","journal-title":"Ann Acad Med Singapore"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/MPG.0b013e3181d3273f"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2009.09.003"},{"key":"e_1_2_8_18_1","first-page":"660","article-title":"Retrospective surveillance for intussusception in children aged less than five years in a South Indian tertiary\u2010care hospital","volume":"27","author":"Bhowmick K","year":"2009","journal-title":"J Health Popul Nutr"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0031-1279735"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1097\/INF.0b013e3181fefdc0"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1080\/00365540802415509"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pediatrneurol.2010.03.002"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.7883\/yoken.JJID.2009.279"},{"key":"e_1_2_8_24_1","unstructured":"Centers for Disease Control and Prevention.VFC childhood vaccine supply policy 2009. Atlanta: Centers for Disease Control and Prevention;2010.https:\/\/www.cdc.gov\/vaccines\/programs\/vfc\/about\/vac-supply-policy\/supply-2009.html. Accessed June 19 2017."},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1093\/jpids\/piw034"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1097\/INF.0b013e31824213b1"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2016.04.050"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2007-1590"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamapediatrics.2013.3924"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4085"},{"key":"e_1_2_8_31_1","first-page":"255","article-title":"Risk of intussusception after rotavirus vaccination","volume":"114","author":"Koch J","year":"2017","journal-title":"Dtsch Arztebl Int"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF01645965"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.2.6204.1551"},{"key":"e_1_2_8_34_1","doi-asserted-by":"publisher","DOI":"10.1093\/pch\/15.8.519"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1097\/INF.0b013e3181af8605"},{"key":"e_1_2_8_36_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cit671"}],"container-title":["Paediatric and Perinatal Epidemiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fppe.12496","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ppe.12496","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,16]],"date-time":"2023-09-16T02:35:25Z","timestamp":1694831725000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ppe.12496"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,7,26]]},"references-count":35,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2018,9]]}},"alternative-id":["10.1111\/ppe.12496"],"URL":"https:\/\/doi.org\/10.1111\/ppe.12496","archive":["Portico"],"relation":{},"ISSN":["0269-5022","1365-3016"],"issn-type":[{"value":"0269-5022","type":"print"},{"value":"1365-3016","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,7,26]]},"assertion":[{"value":"2018-02-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-06-12","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-07-26","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}