{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T07:37:02Z","timestamp":1767857822284,"version":"3.49.0"},"reference-count":25,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2015,5,27]],"date-time":"2015-05-27T00:00:00Z","timestamp":1432684800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2015,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p><jats:italic>Rotarix<\/jats:italic><jats:sup>TM<\/jats:sup> was launched in November 2011 in Japan to prevent rotavirus gastroenteritis. Some studies suggest that <jats:italic>Rotarix<\/jats:italic><jats:sup>TM<\/jats:sup> may have a temporal association with a risk of intussusception (IS). We assessed a possible association between IS and <jats:italic>Rotarix<\/jats:italic><jats:sup>TM<\/jats:sup> vaccination in Japan.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>All IS cases spontaneously reported post\u2010vaccination (Brighton collaboration levels 1, 2, and 3) were extracted from the GlaxoSmithKline spontaneous report database on the 11th of January 2013. Expected numbers of IS cases were estimated using the number of vaccine doses distributed and the Japanese incidence rate of IS stratified by month of age. The observed versus expected analysis considered the IS cases for each risk period (7 and 30\u2009days post\u2010vaccination) and for each vaccine dose (two doses).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Before January 2013, approximately 601\u2009000 <jats:italic>Rotarix<\/jats:italic><jats:sup>TM<\/jats:sup> doses were distributed in Japan. For a risk period of 7\u2009days post\u2010dose 1 and post\u2010dose 2, 10 and five IS cases were observed, whereas 3.4 and 7.6 were expected, providing an observed\u2010to\u2010expected ratio of 2.96 (95% confidence interval [CI]: 1.42; 5.45) and 0.66 (95% CI: 0.21; 1.53), respectively. For a risk period of 30\u2009days post\u2010dose 1 and post\u2010dose 2, 14 and eight cases were observed, whereas 14.5 and 32.7 were expected, providing an observed\u2010to\u2010expected ratio of 0.97 (95% CI: 0.53; 1.62) and 0.24 (95% CI: 0.11; 0.48), respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>A statistically significant excess of IS cases was observed within 7\u2009days post\u2010dose 1, but not post\u2010dose 2. These results are consistent with previous observations in large post\u2010marketing safety studies in other world regions. \u00a9 2015 The Authors. <jats:italic>Pharmacoepidemiology and Drug Safety<\/jats:italic> published by John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.3800","type":"journal-article","created":{"date-parts":[[2015,5,27]],"date-time":"2015-05-27T17:10:09Z","timestamp":1432746609000},"page":"765-770","source":"Crossref","is-referenced-by-count":20,"title":["Post\u2010marketing monitoring of intussusception after rotavirus vaccination in Japan"],"prefix":"10.1002","volume":"24","author":[{"given":"Vincent","family":"Bauchau","sequence":"first","affiliation":[{"name":"Safety Department GSK Vaccines  Wavre Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7354-6475","authenticated-orcid":false,"given":"Lionel","family":"Van Holle","sequence":"additional","affiliation":[{"name":"Safety Department GSK Vaccines  Wavre Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olivia","family":"Mahaux","sequence":"additional","affiliation":[{"name":"Safety Department GSK Vaccines  Wavre Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katsiaryna","family":"Holl","sequence":"additional","affiliation":[{"name":"Health Economics Department GSK Vaccines  Wavre Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keiji","family":"Sugiyama","sequence":"additional","affiliation":[{"name":"Japan Vaccine Co., Ltd.  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hubert","family":"Buyse","sequence":"additional","affiliation":[{"name":"Safety Department GSK Vaccines  Wavre Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,5,27]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/174.Supplement_1.S65"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/00006454-200104000-00008"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejm200102223440804"},{"key":"e_1_2_11_5_1","volume-title":"Acute Intussusception in Infants and Young Children: Incidence, Clinical Presentation and Management: A Global Perspective. 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April 2009\u2013conclusions and recommendations","volume":"84","year":"2009","journal-title":"Wkly Epidemiol Rec"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1303164"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1311738"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2012-2554"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cit520"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1097\/INF.0b013e318253add3"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1012952"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2011.01.088"},{"key":"e_1_2_11_22_1","unstructured":"Pharmaceuticals and medical devices agency Japan. 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