{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,28]],"date-time":"2026-01-28T21:51:36Z","timestamp":1769637096297,"version":"3.49.0"},"reference-count":30,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2018,7,20]],"date-time":"2018-07-20T00:00:00Z","timestamp":1532044800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2018,7,20]],"date-time":"2018-07-20T00:00:00Z","timestamp":1532044800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["OPP1165083"],"award-info":[{"award-number":["OPP1165083"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Public Health"],"published-print":{"date-parts":[[2018,12]]},"DOI":"10.1186\/s12889-018-5809-7","type":"journal-article","created":{"date-parts":[[2018,7,20]],"date-time":"2018-07-20T08:45:36Z","timestamp":1532076336000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["Safety monitoring of ROTAVAC vaccine and etiological investigation of intussusception in India: study protocol"],"prefix":"10.1186","volume":"18","author":[{"name":"Indian Intussusception Surveillance Network","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samarasimha","family":"Reddy","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nayana P.","family":"Nair","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sidhartha","family":"Giri","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Venkata Raghava","family":"Mohan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacqueline E.","family":"Tate","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Umesh D.","family":"Parashar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohan D.","family":"Gupte","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rashmi","family":"Arora","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3656-564X","authenticated-orcid":false,"given":"Gagandeep","family":"Kang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2018,7,20]]},"reference":[{"key":"5809_CR1","doi-asserted-by":"publisher","first-page":"S96","DOI":"10.1093\/cid\/civ1013","volume":"62","author":"JE Tate","year":"2016","unstructured":"Tate JE, Burton AH, Boschi-Pinto C, Parashar UD, Agocs M, Serhan F, et al. Global, regional, and National Estimates of rotavirus mortality in children <5 years of age, 2000\u20132013. Clin Infect Dis. 2016;62:S96\u2013105.","journal-title":"Clin Infect Dis"},{"issue":"Supplement 1","key":"5809_CR2","doi-asserted-by":"publisher","first-page":"A5","DOI":"10.1016\/j.vaccine.2014.03.004","volume":"32","author":"J John","year":"2014","unstructured":"John J, Sarkar R, Muliyil J, Bhandari N, Bhan MK, Kang G. Rotavirus gastroenteritis in India, 2011\u20132013: Revised estimates of disease burden and potential impact of vaccines. Vaccine. 2014;32(Supplement 1):A5\u20139.","journal-title":"Vaccine"},{"key":"5809_CR3","first-page":"49","volume":"88","author":"WHO","year":"2013","unstructured":"WHO. Rotavirus vaccines. WHO position paper \u2013 January 2013. Wkly Epidemiol Rec. 2013;88:49\u201364.","journal-title":"Wkly Epidemiol Rec"},{"key":"5809_CR4","doi-asserted-by":"publisher","first-page":"2136","DOI":"10.1016\/S0140-6736(13)62630-6","volume":"383","author":"N Bhandari","year":"2014","unstructured":"Bhandari N, Rongsen-Chandola T, Bavdekar A, John J, Antony K, Taneja S, et al. Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial. Lancet. 2014;383:2136\u201343.","journal-title":"Lancet"},{"key":"5809_CR5","unstructured":"Shri JP Nadda launches Rotavirus vaccine as part of Universal Immunization Programme; terms it a \u201chistoric moment\u201d [Internet]. Available from: \n                    http:\/\/pib.nic.in\/newsite\/PrintRelease.aspx?relid=138342\n                    \n                   [cited 2018 Jun 17]."},{"key":"5809_CR6","unstructured":"Shri JP Nadda launches expansion of Rotavirus vaccine under Universal Immunization Programme [Internet]. Available from: \n                    http:\/\/pib.nic.in\/newsite\/PrintRelease.aspx?relid=158549\n                    \n                   [cited 2018 Jun 17]."},{"key":"5809_CR7","doi-asserted-by":"publisher","first-page":"564","DOI":"10.1056\/NEJM200102223440804","volume":"344","author":"TV Murphy","year":"2001","unstructured":"Murphy TV, Gargiullo PM, Massoudi MS, Nelson DB, Jumaan AO, Okoro CA, et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med. 2001;344:564\u201372.","journal-title":"N Engl J Med"},{"key":"5809_CR8","unstructured":"Advisory Committee on Immunization Practices (ACIP). Rotavirus vaccine for the prevention of rotavirus gastroenteritis among children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep Morb Mortal Wkly Rep Recomm Rep. 1999;48:1\u201320."},{"key":"5809_CR9","doi-asserted-by":"publisher","first-page":"1483","DOI":"10.1542\/peds.102.6.1483","volume":"102","author":"Diseases C on I","year":"1998","unstructured":"Diseases C on I. Prevention of rotavirus disease: guidelines for use of rotavirus vaccine. Pediatrics. 1998;102:1483\u201391.","journal-title":"Pediatrics"},{"key":"5809_CR10","first-page":"1007","volume":"48","author":"Centers for Disease Control and Prevention (CDC)","year":"1999","unstructured":"Centers for Disease Control and Prevention (CDC). Withdrawal of rotavirus vaccine recommendation. MMWR Morb Mortal Wkly Rep. 1999;48:1007.","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"5809_CR11","doi-asserted-by":"publisher","first-page":"10","DOI":"10.1155\/2000\/414396","volume":"11","author":"G Delage","year":"2000","unstructured":"Delage G. Rotavirus vaccine withdrawal in the United States; the role of postmarketing surveillance. Can J Infect Dis. 2000;11:10\u20132.","journal-title":"Can J Infect Dis"},{"key":"5809_CR12","doi-asserted-by":"publisher","first-page":"S377","DOI":"10.1016\/j.amepre.2015.09.005","volume":"49","author":"UD Parashar","year":"2015","unstructured":"Parashar UD, Cortese MM, Payne DC, Lopman B, Yen C, Tate JE. Value of post-licensure data on benefits and risks of vaccination to inform vaccine policy: the example of rotavirus vaccines. Am J Prev Med. 2015;49:S377\u201382.","journal-title":"Am J Prev Med"},{"key":"5809_CR13","doi-asserted-by":"publisher","first-page":"2580","DOI":"10.1080\/21645515.2016.1197452","volume":"12","author":"C Yen","year":"2016","unstructured":"Yen C, Healy K, Tate JE, Parashar UD, Bines J, Neuzil K, et al. Rotavirus vaccination and intussusception \u2013 science, surveillance, and safety: a review of evidence and recommendations for future research priorities in low and middle income countries. Hum Vaccines Immunother. 2016;12:2580\u20139.","journal-title":"Hum Vaccines Immunother"},{"key":"5809_CR14","doi-asserted-by":"publisher","first-page":"A179","DOI":"10.1016\/j.vaccine.2011.08.110","volume":"30","author":"JE Tate","year":"2012","unstructured":"Tate JE, Steele AD, Bines JE, Zuber PLF, Parashar UD. Research priorities regarding rotavirus vaccine and intussusception: a meeting summary. Vaccine. 2012;30:A179\u201384.","journal-title":"Vaccine"},{"key":"5809_CR15","doi-asserted-by":"publisher","first-page":"503","DOI":"10.1056\/NEJMoa1303164","volume":"370","author":"WK Yih","year":"2014","unstructured":"Yih WK, Lieu TA, Kulldorff M, Martin D, McMahill-Walraven CN, Platt R, et al. Intussusception risk after rotavirus vaccination in U.S. infants. N Engl J Med. 2014;370:503\u201312.","journal-title":"N Engl J Med"},{"key":"5809_CR16","doi-asserted-by":"publisher","first-page":"513","DOI":"10.1056\/NEJMoa1311738","volume":"370","author":"ES Weintraub","year":"2014","unstructured":"Weintraub ES, Baggs J, Duffy J, Vellozzi C, Belongia EA, Irving S, et al. Risk of intussusception after monovalent rotavirus vaccination. N Engl J Med. 2014;370:513\u20139.","journal-title":"N Engl J Med"},{"key":"5809_CR17","unstructured":"Julie Bines. WHO |Post-marketing surveillance of rotavirus vaccine safety [Internet]. WHO. Available from: \n                    http:\/\/www.who.int\/immunization\/documents\/WHO_IVB_09.01\/en\/\n                    \n                   [cited 2018 Jun 17]."},{"key":"5809_CR18","doi-asserted-by":"publisher","first-page":"169","DOI":"10.1016\/0046-8177(94)90274-7","volume":"25","author":"EA Montgomery","year":"1994","unstructured":"Montgomery EA, Popek EJ. Intussusception, adenovirus, and children: a brief reaffirmation. Hum Pathol. 1994;25:169\u201374.","journal-title":"Hum Pathol"},{"key":"5809_CR19","doi-asserted-by":"publisher","first-page":"154","DOI":"10.1136\/jcp.46.2.154","volume":"46","author":"HJ Porter","year":"1993","unstructured":"Porter HJ, Padfield CJ, Peres LC, Hirschowitz L, Berry PJ. Adenovirus and intranuclear inclusions in appendices in intussusception. J Clin Pathol. 1993;46:154\u20138.","journal-title":"J Clin Pathol"},{"key":"5809_CR20","doi-asserted-by":"publisher","first-page":"e641","DOI":"10.1016\/j.ijid.2011.05.008","volume":"15","author":"S Okimoto","year":"2011","unstructured":"Okimoto S, Hyodo S, Yamamoto M, Nakamura K, Kobayashi M. Association of viral isolates from stool samples with intussusception in children. Int J Infect Dis. 2011;15:e641\u20135.","journal-title":"Int J Infect Dis"},{"key":"5809_CR21","doi-asserted-by":"publisher","first-page":"452","DOI":"10.1016\/j.jpeds.2006.04.010","volume":"149","author":"JE Bines","year":"2006","unstructured":"Bines JE, Liem NT, Justice FA, Son TN, Kirkwood CD, de Campo M, et al. Risk factors for intussusception in infants in Vietnam and Australia: Adenovirus implicated, but not rotavirus. J Pediatr. 2006;149:452\u201360. e1","journal-title":"J Pediatr"},{"key":"5809_CR22","doi-asserted-by":"publisher","first-page":"i4515","DOI":"10.1136\/bmj.i4515","volume":"354","author":"I Petersen","year":"2016","unstructured":"Petersen I, Douglas I, Whitaker H. Self controlled case series methods: an alternative to standard epidemiological study designs. BMJ. 2016;354:i4515.","journal-title":"BMJ"},{"key":"5809_CR23","doi-asserted-by":"publisher","first-page":"569","DOI":"10.1016\/j.vaccine.2003.09.016","volume":"22","author":"JE Bines","year":"2004","unstructured":"Bines JE, Kohl KS, Forster J, Zanardi LR, Davis RL, Hansen J, et al. Acute intussusception in infants and children as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation. Vaccine. 2004;22:569\u201374.","journal-title":"Vaccine"},{"key":"5809_CR24","doi-asserted-by":"publisher","first-page":"472","DOI":"10.1128\/JCM.02658-12","volume":"51","author":"J Liu","year":"2013","unstructured":"Liu J, Gratz J, Amour C, Kibiki G, Becker S, Janaki L, et al. A laboratory-developed TaqMan Array card for simultaneous detection of 19 Enteropathogens. J Clin Microbiol. 2013;51:472\u201380.","journal-title":"J Clin Microbiol"},{"key":"5809_CR25","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1093\/biostatistics\/kxn013","volume":"10","author":"CP Farrington","year":"2009","unstructured":"Farrington CP, Whitaker HJ, Hocine MN. Case series analysis for censored, perturbed, or curtailed post-event exposures. Biostatistics. 2009;10:3\u201316.","journal-title":"Biostatistics"},{"key":"5809_CR26","doi-asserted-by":"publisher","first-page":"7","DOI":"10.1177\/0962280208092342","volume":"18","author":"HJ Whitaker","year":"2009","unstructured":"Whitaker HJ, Hocine MN, Farrington CP. The methodology of self-controlled case series studies. Stat Methods Med Res. 2009;18:7\u201326.","journal-title":"Stat Methods Med Res"},{"key":"5809_CR27","doi-asserted-by":"publisher","first-page":"904","DOI":"10.1093\/oxfordjournals.aje.a114174","volume":"122","author":"P Bruzzi","year":"1985","unstructured":"Bruzzi P, Green SB, Byar DP, Brinton LA, Schairer C. Estimating the population attributable risk for multiple risk factors using case-control data. Am J Epidemiol. 1985;122:904\u201314.","journal-title":"Am J Epidemiol"},{"key":"5809_CR28","doi-asserted-by":"publisher","first-page":"S246","DOI":"10.1093\/cid\/cis788","volume":"55","author":"WC Blackwelder","year":"2012","unstructured":"Blackwelder WC, Biswas K, Wu Y, Kotloff KL, Farag TH, Nasrin D, et al. Statistical methods in the global enteric multicenter study (GEMS). Clin Infect Dis. 2012;55:S246\u201353.","journal-title":"Clin Infect Dis"},{"key":"5809_CR29","unstructured":"Indian Public Health Standards - Governnment of India [Internet]. Available from: \n                    http:\/\/nhm.gov.in\/nhm\/nrhm\/guidelines\/indian-public-health-standards.html\n                    \n                   [cited 2018 May 5]."},{"key":"5809_CR30","unstructured":"Meeting on Future Directions for Rotavirus Vaccine Research in Developing Countries (2000: Geneva, Switzerland & WHO Department of Vaccines and Biologicals. Report of the meeting on future directions for rotavirus vaccine research in developing countries, Geneva, 9\u201311 February 2000. Available from: \n                    http:\/\/apps.who.int\/iris\/handle\/10665\/66497\n                    \n                   [cited 2018 Jun 17]."}],"container-title":["BMC Public Health"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12889-018-5809-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s12889-018-5809-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12889-018-5809-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,5,14]],"date-time":"2020-05-14T12:42:13Z","timestamp":1589460133000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcpublichealth.biomedcentral.com\/articles\/10.1186\/s12889-018-5809-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,7,20]]},"references-count":30,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2018,12]]}},"alternative-id":["5809"],"URL":"https:\/\/doi.org\/10.1186\/s12889-018-5809-7","relation":{},"ISSN":["1471-2458"],"issn-type":[{"value":"1471-2458","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,7,20]]},"assertion":[{"value":"17 June 2018","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"5 July 2018","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 July 2018","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Not applicable","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Venkata Raghava Mohan is an Associate Editor for BMC Public Health. The other authors declare that they have no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Publisher\u2019s Note"}}],"article-number":"898"}}