Intussusception following rotavirus vaccine administration: Post-marketing surveillance in the National Immunization Program in Australia
Abstract Introduction In Australia, post-marketing surveillance for intussusception following vaccination commenced with funding of RotaTeq ® and Rotarix ® vaccines under the National Immunization Program (NIP) in July 2007. Methods Two active surveillance mechanisms (hospital-based case ascertainme...
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description | Abstract Introduction In Australia, post-marketing surveillance for intussusception following vaccination commenced with funding of RotaTeq ® and Rotarix ® vaccines under the National Immunization Program (NIP) in July 2007. Methods Two active surveillance mechanisms (hospital-based case ascertainment and monthly reports from paediatricians) identified intussusception cases between 1st July 2007 and 31st December 2008 in four states. Linkage to vaccination records identified cases occurring within 1–7 and 1–21 days of rotavirus vaccination. Expected cases within the post-vaccination windows were calculated by applying rates of intussusception from national hospitalisation data over 6 years (mid-2000 to mid-2006), by age and state, to numbers vaccinated (by dose) according to the Australian Childhood Immunization Register. Results Combining exposure windows associated with all doses of rotavirus vaccine from 1 to 9 months of age, there was no evidence of an increased risk of intussusception following vaccination for either vaccine. However, in infants 1 to |
doi_str_mv | 10.1016/j.vaccine.2011.01.088 |
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Methods Two active surveillance mechanisms (hospital-based case ascertainment and monthly reports from paediatricians) identified intussusception cases between 1st July 2007 and 31st December 2008 in four states. Linkage to vaccination records identified cases occurring within 1–7 and 1–21 days of rotavirus vaccination. Expected cases within the post-vaccination windows were calculated by applying rates of intussusception from national hospitalisation data over 6 years (mid-2000 to mid-2006), by age and state, to numbers vaccinated (by dose) according to the Australian Childhood Immunization Register. Results Combining exposure windows associated with all doses of rotavirus vaccine from 1 to 9 months of age, there was no evidence of an increased risk of intussusception following vaccination for either vaccine. However, in infants 1 to <3 months of age, there was suggestive evidence of excess intussusception cases 1–7 and 1–21 days following dose 1 (1–7 days: RotaTeq ® relative risk (RR) = 5.3, 95% confidence interval [CI] 1.1,15.4; Rotarix ® RR 3.5, 95% CI 0.7,10.1; 1–21 days: RotaTeq ® RR 3.5, 95% CI 1.3, 7.6; Rotarix ® RR 1.5, 95% CI 0.4, 3.9). There was no evidence that clinical outcome of intussusception occurring within 21 days of rotavirus vaccination differed from that in cases occurring later post-vaccination. Conclusion Although we found no overall increase in intussusception following receipt of rotavirus vaccine, there was some evidence of an elevated risk following the first dose of both vaccines. Larger population-based studies using linked databases are required to provide more definitive evidence.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2011.01.088</identifier><identifier>PMID: 21316503</identifier><identifier>CODEN: VACCDE</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Adverse Drug Reaction Reporting Systems - statistics & numerical data ; Allergy and Immunology ; Applied microbiology ; Australia - epidemiology ; Biological and medical sciences ; childhood ; Children & youth ; confidence interval ; Diarrhea ; Fundamental and applied biological sciences. Psychology ; funding ; Humans ; Immunization ; Immunization Programs ; Infant ; infants ; Intussusception ; Intussusception - chemically induced ; Intussusception - epidemiology ; Microbiology ; Miscellaneous ; monitoring ; Population studies ; Post-marketing surveillance ; Product Surveillance, Postmarketing ; relative risk ; Risk Assessment ; Rotarix ; RotaTeq ; Rotavirus ; Rotavirus vaccine ; Rotavirus Vaccines - adverse effects ; vaccination ; Vaccines ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) ; Vaccines, Attenuated - adverse effects ; Virology</subject><ispartof>Vaccine, 2011-04, Vol.29 (16), p.3061-3066</ispartof><rights>Elsevier Ltd</rights><rights>2011 Elsevier Ltd</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Apr 5, 2011</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c599t-a0ffb91615cbc2dd9520a7260cdbfa8956b463089f34524478fff972bd81489e3</citedby><cites>FETCH-LOGICAL-c599t-a0ffb91615cbc2dd9520a7260cdbfa8956b463089f34524478fff972bd81489e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0264410X11001605$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24082163$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21316503$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Buttery, J.P</creatorcontrib><creatorcontrib>Danchin, M.H</creatorcontrib><creatorcontrib>Lee, K.J</creatorcontrib><creatorcontrib>Carlin, J.B</creatorcontrib><creatorcontrib>McIntyre, P.B</creatorcontrib><creatorcontrib>Elliott, E.J</creatorcontrib><creatorcontrib>Booy, R</creatorcontrib><creatorcontrib>Bines, J.E</creatorcontrib><creatorcontrib>for the PAEDS/APSU Study Group</creatorcontrib><creatorcontrib>PAEDS/APSU Study Group</creatorcontrib><title>Intussusception following rotavirus vaccine administration: Post-marketing surveillance in the National Immunization Program in Australia</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>Abstract Introduction In Australia, post-marketing surveillance for intussusception following vaccination commenced with funding of RotaTeq ® and Rotarix ® vaccines under the National Immunization Program (NIP) in July 2007. Methods Two active surveillance mechanisms (hospital-based case ascertainment and monthly reports from paediatricians) identified intussusception cases between 1st July 2007 and 31st December 2008 in four states. Linkage to vaccination records identified cases occurring within 1–7 and 1–21 days of rotavirus vaccination. Expected cases within the post-vaccination windows were calculated by applying rates of intussusception from national hospitalisation data over 6 years (mid-2000 to mid-2006), by age and state, to numbers vaccinated (by dose) according to the Australian Childhood Immunization Register. Results Combining exposure windows associated with all doses of rotavirus vaccine from 1 to 9 months of age, there was no evidence of an increased risk of intussusception following vaccination for either vaccine. However, in infants 1 to <3 months of age, there was suggestive evidence of excess intussusception cases 1–7 and 1–21 days following dose 1 (1–7 days: RotaTeq ® relative risk (RR) = 5.3, 95% confidence interval [CI] 1.1,15.4; Rotarix ® RR 3.5, 95% CI 0.7,10.1; 1–21 days: RotaTeq ® RR 3.5, 95% CI 1.3, 7.6; Rotarix ® RR 1.5, 95% CI 0.4, 3.9). There was no evidence that clinical outcome of intussusception occurring within 21 days of rotavirus vaccination differed from that in cases occurring later post-vaccination. Conclusion Although we found no overall increase in intussusception following receipt of rotavirus vaccine, there was some evidence of an elevated risk following the first dose of both vaccines. Larger population-based studies using linked databases are required to provide more definitive evidence.</description><subject>Adverse Drug Reaction Reporting Systems - statistics & numerical data</subject><subject>Allergy and Immunology</subject><subject>Applied microbiology</subject><subject>Australia - epidemiology</subject><subject>Biological and medical sciences</subject><subject>childhood</subject><subject>Children & youth</subject><subject>confidence interval</subject><subject>Diarrhea</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>funding</subject><subject>Humans</subject><subject>Immunization</subject><subject>Immunization Programs</subject><subject>Infant</subject><subject>infants</subject><subject>Intussusception</subject><subject>Intussusception - chemically induced</subject><subject>Intussusception - epidemiology</subject><subject>Microbiology</subject><subject>Miscellaneous</subject><subject>monitoring</subject><subject>Population studies</subject><subject>Post-marketing surveillance</subject><subject>Product Surveillance, Postmarketing</subject><subject>relative risk</subject><subject>Risk Assessment</subject><subject>Rotarix</subject><subject>RotaTeq</subject><subject>Rotavirus</subject><subject>Rotavirus vaccine</subject><subject>Rotavirus Vaccines - adverse effects</subject><subject>vaccination</subject><subject>Vaccines</subject><subject>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</subject><subject>Vaccines, Attenuated - adverse effects</subject><subject>Virology</subject><issn>0264-410X</issn><issn>1873-2518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkt-K1DAUxoso7rj6CGpBxKuOJ2nSJnuhLIt_BhZdWBe8C2majJltmzFpR9Y38K1NZqoLe7MQKIXf-c53zney7DmCJQJUvd0sd1IpO-glBoSWEB9jD7IFYnVZYIrYw2wBuCIFQfD9KHsSwgYAaIn44-wIoxJVFMpF9mc1jFMIU1B6O1o35MZ1nftlh3Xu3Sh31k8hnzvlsu3tYMPoZUJP8gsXxqKX_lqPqSBMfqdt18lB6dwO-fhD51_2qOzyVd9Pg_29_80vvFt72SfodEp6nZVPs0dGdkE_m7_H2dXHD9_OPhfnXz-tzk7PC0U5HwsJxjQcVYiqRuG25RSDrHEFqm2MZJxWDalKYNyUhGJCamaM4TVuWoYI47o8zt4cdLfe_Zx0GEVv4_TJtnZTEKyO22FQ0vvJqiasRARH8tUdcuMmH8cOIjplnJSIJj16oJR3IXhtxNbbuL4bgUCkUMVGzKsWKVQB8TEW617M6lPT6_Z_1b8UI_B6BmRQsjM-JmDDLUeAYVQl7uWBM9IJufaRubqMnShAHJnvW70_EDomsLPai6Csjnm21ms1itbZe82-u6Ogung00da1vtHhdi8iYAHiMt1oOlGEookqHuhfefXjAg</recordid><startdate>20110405</startdate><enddate>20110405</enddate><creator>Buttery, J.P</creator><creator>Danchin, M.H</creator><creator>Lee, K.J</creator><creator>Carlin, J.B</creator><creator>McIntyre, P.B</creator><creator>Elliott, E.J</creator><creator>Booy, R</creator><creator>Bines, J.E</creator><general>Elsevier Ltd</general><general>Elsevier</general><general>Elsevier Limited</general><scope>FBQ</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7RV</scope><scope>7T2</scope><scope>7T5</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20110405</creationdate><title>Intussusception following rotavirus vaccine administration: Post-marketing surveillance in the National Immunization Program in Australia</title><author>Buttery, J.P ; Danchin, M.H ; Lee, K.J ; Carlin, J.B ; McIntyre, P.B ; Elliott, E.J ; Booy, R ; Bines, J.E</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c599t-a0ffb91615cbc2dd9520a7260cdbfa8956b463089f34524478fff972bd81489e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adverse Drug Reaction Reporting Systems - statistics & numerical data</topic><topic>Allergy and Immunology</topic><topic>Applied microbiology</topic><topic>Australia - epidemiology</topic><topic>Biological and medical sciences</topic><topic>childhood</topic><topic>Children & youth</topic><topic>confidence interval</topic><topic>Diarrhea</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>funding</topic><topic>Humans</topic><topic>Immunization</topic><topic>Immunization Programs</topic><topic>Infant</topic><topic>infants</topic><topic>Intussusception</topic><topic>Intussusception - chemically induced</topic><topic>Intussusception - epidemiology</topic><topic>Microbiology</topic><topic>Miscellaneous</topic><topic>monitoring</topic><topic>Population studies</topic><topic>Post-marketing surveillance</topic><topic>Product Surveillance, Postmarketing</topic><topic>relative risk</topic><topic>Risk Assessment</topic><topic>Rotarix</topic><topic>RotaTeq</topic><topic>Rotavirus</topic><topic>Rotavirus vaccine</topic><topic>Rotavirus Vaccines - adverse effects</topic><topic>vaccination</topic><topic>Vaccines</topic><topic>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</topic><topic>Vaccines, Attenuated - adverse effects</topic><topic>Virology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Buttery, J.P</creatorcontrib><creatorcontrib>Danchin, M.H</creatorcontrib><creatorcontrib>Lee, K.J</creatorcontrib><creatorcontrib>Carlin, J.B</creatorcontrib><creatorcontrib>McIntyre, P.B</creatorcontrib><creatorcontrib>Elliott, E.J</creatorcontrib><creatorcontrib>Booy, R</creatorcontrib><creatorcontrib>Bines, J.E</creatorcontrib><creatorcontrib>for the PAEDS/APSU Study Group</creatorcontrib><creatorcontrib>PAEDS/APSU Study Group</creatorcontrib><collection>AGRIS</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Nursing & Allied Health Database</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Vaccine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Buttery, J.P</au><au>Danchin, M.H</au><au>Lee, K.J</au><au>Carlin, J.B</au><au>McIntyre, P.B</au><au>Elliott, E.J</au><au>Booy, R</au><au>Bines, J.E</au><aucorp>for the PAEDS/APSU Study Group</aucorp><aucorp>PAEDS/APSU Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Intussusception following rotavirus vaccine administration: Post-marketing surveillance in the National Immunization Program in Australia</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2011-04-05</date><risdate>2011</risdate><volume>29</volume><issue>16</issue><spage>3061</spage><epage>3066</epage><pages>3061-3066</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><coden>VACCDE</coden><abstract>Abstract Introduction In Australia, post-marketing surveillance for intussusception following vaccination commenced with funding of RotaTeq ® and Rotarix ® vaccines under the National Immunization Program (NIP) in July 2007. Methods Two active surveillance mechanisms (hospital-based case ascertainment and monthly reports from paediatricians) identified intussusception cases between 1st July 2007 and 31st December 2008 in four states. Linkage to vaccination records identified cases occurring within 1–7 and 1–21 days of rotavirus vaccination. Expected cases within the post-vaccination windows were calculated by applying rates of intussusception from national hospitalisation data over 6 years (mid-2000 to mid-2006), by age and state, to numbers vaccinated (by dose) according to the Australian Childhood Immunization Register. Results Combining exposure windows associated with all doses of rotavirus vaccine from 1 to 9 months of age, there was no evidence of an increased risk of intussusception following vaccination for either vaccine. However, in infants 1 to <3 months of age, there was suggestive evidence of excess intussusception cases 1–7 and 1–21 days following dose 1 (1–7 days: RotaTeq ® relative risk (RR) = 5.3, 95% confidence interval [CI] 1.1,15.4; Rotarix ® RR 3.5, 95% CI 0.7,10.1; 1–21 days: RotaTeq ® RR 3.5, 95% CI 1.3, 7.6; Rotarix ® RR 1.5, 95% CI 0.4, 3.9). There was no evidence that clinical outcome of intussusception occurring within 21 days of rotavirus vaccination differed from that in cases occurring later post-vaccination. Conclusion Although we found no overall increase in intussusception following receipt of rotavirus vaccine, there was some evidence of an elevated risk following the first dose of both vaccines. Larger population-based studies using linked databases are required to provide more definitive evidence.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>21316503</pmid><doi>10.1016/j.vaccine.2011.01.088</doi><tpages>6</tpages></addata></record> |
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subjects | Adverse Drug Reaction Reporting Systems - statistics & numerical data Allergy and Immunology Applied microbiology Australia - epidemiology Biological and medical sciences childhood Children & youth confidence interval Diarrhea Fundamental and applied biological sciences. Psychology funding Humans Immunization Immunization Programs Infant infants Intussusception Intussusception - chemically induced Intussusception - epidemiology Microbiology Miscellaneous monitoring Population studies Post-marketing surveillance Product Surveillance, Postmarketing relative risk Risk Assessment Rotarix RotaTeq Rotavirus Rotavirus vaccine Rotavirus Vaccines - adverse effects vaccination Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vaccines, Attenuated - adverse effects Virology |
title | Intussusception following rotavirus vaccine administration: Post-marketing surveillance in the National Immunization Program in Australia |
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