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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Veröffentlicht in:Vaccine 2011-04, Vol.29 (16), p.3061-3066
Hauptverfasser: Buttery, J.P, Danchin, M.H, Lee, K.J, Carlin, J.B, McIntyre, P.B, Elliott, E.J, Booy, R, Bines, J.E
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container_end_page 3066
container_issue 16
container_start_page 3061
container_title Vaccine
container_volume 29
creator Buttery, J.P
Danchin, M.H
Lee, K.J
Carlin, J.B
McIntyre, P.B
Elliott, E.J
Booy, R
Bines, J.E
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 &lt;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 &amp; numerical data ; Allergy and Immunology ; Applied microbiology ; Australia - epidemiology ; Biological and medical sciences ; childhood ; Children &amp; 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>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=24082163$$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 &lt;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. 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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 &amp; 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 &amp; 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 &amp; 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Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health &amp; 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 &amp; 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 &lt;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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source MEDLINE; Elsevier ScienceDirect Journals
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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