Successful methodology for large-scale surveillance of severe events following influenza vaccination in Canada, 2011 and 2012.
Identifieur interne : 000179 ( Main/Exploration ); précédent : 000178; suivant : 000180Successful methodology for large-scale surveillance of severe events following influenza vaccination in Canada, 2011 and 2012.
Auteurs : J A Bettinger [Canada] ; I. Rouleau ; M C Gariepy ; W R Bowie ; L. Valiquette ; O G Vanderkooi ; J D Kellner ; B L Coleman ; S A Mcneil ; A. Mccarthy ; G. De SerresSource :
- Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin [ 1560-7917 ] ; 2015.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Canada (épidémiologie), Enquêtes et questionnaires, Femelle, Grippe humaine (), Grippe humaine (épidémiologie), Humains, Immunisation (effets indésirables), Mâle, Personnel de santé, Sous-type H1N1 du virus de la grippe A (immunologie), Sujet âgé, Surveillance de la population (), Systèmes de signalement des effets indésirables des médicaments, Vaccination (), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Épidémiosurveillance, Études cas-témoins, Évaluation de programme.
- MESH :
- administration et posologie : Vaccins antigrippaux.
- effets indésirables : Immunisation, Vaccins antigrippaux.
- immunologie : Sous-type H1N1 du virus de la grippe A.
- épidémiologie : Canada, Grippe humaine.
- Adulte, Adulte d'âge moyen, Enquêtes et questionnaires, Femelle, Grippe humaine, Humains, Mâle, Personnel de santé, Sujet âgé, Surveillance de la population, Systèmes de signalement des effets indésirables des médicaments, Vaccination, Épidémiosurveillance, Études cas-témoins, Évaluation de programme.
- Wicri :
- geographic : Canada.
English descriptors
- KwdEn :
- Adult, Adverse Drug Reaction Reporting Systems, Aged, Canada (epidemiology), Case-Control Studies, Epidemiological Monitoring, Female, Health Personnel, Humans, Immunization (adverse effects), Influenza A Virus, H1N1 Subtype (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza, Human (epidemiology), Influenza, Human (prevention & control), Male, Middle Aged, Population Surveillance (methods), Program Evaluation, Surveys and Questionnaires, Vaccination (methods).
- MESH :
- chemical , administration & dosage : Influenza Vaccines.
- chemical , adverse effects : Influenza Vaccines.
- geographic , epidemiology : Canada.
- adverse effects : Immunization.
- epidemiology : Influenza, Human.
- immunology : Influenza A Virus, H1N1 Subtype.
- methods : Population Surveillance, Vaccination.
- prevention & control : Influenza, Human.
- Adult, Adverse Drug Reaction Reporting Systems, Aged, Case-Control Studies, Epidemiological Monitoring, Female, Health Personnel, Humans, Male, Middle Aged, Program Evaluation, Surveys and Questionnaires.
Abstract
In 2011 and 2012, a nationwide Canadian vaccine safety surveillance network rapidly collected safety data from healthcare workers (HCW) during the first weeks of the annual influenza vaccination campaign. This network provided the first available post-marketing safety data on seasonal influenza vaccines with information on background rates as a comparator. In 2012, these data were used to investigate a possible safety concern regarding a particular vaccine. An online questionnaire was provided to participating HCW two weeks before the annual influenza vaccination campaign for controls, and eight days after influenza vaccination for vaccinees. Control and vaccinees were requested to report health events occurring in the seven days prior to receiving the questionnaire. Control data were used to calculate background rates. HCW reporting a severe event were followed-up by telephone within 48 hours of the online report to validate the report and check on their health status. More than 22,000 vaccinated HCW were enrolled and surveyed over two seasons and > 90% reported no severe event following vaccination. Validated severe event rates were similar in vaccinated HCW and unvaccinated HCW (2.2% vs 2.3%; p < 0.70). The questionnaire was accurately completed for most reported symptoms, matched the validated report and was able to detect events of interest. Prior to the safety concern, the implicated vaccine was in use at one centre. Reassuring safety data were provided to public health authorities 48 hours after the vaccine was temporarily suspended. Data from this and similar networks can be used for rapid evaluation of vaccine safety and for safety assessment as required by the European Medicines Agency in 2015.
DOI: 10.2807/1560-7917.es2015.20.29.21189
PubMed: 26227369
Affiliations:
Links toward previous steps (curation, corpus...)
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Rouleau</name></author><author><name sortKey="Gariepy, M C" sort="Gariepy, M C" uniqKey="Gariepy M" first="M C" last="Gariepy">M C Gariepy</name></author><author><name sortKey="Bowie, W R" sort="Bowie, W R" uniqKey="Bowie W" first="W R" last="Bowie">W R Bowie</name></author><author><name sortKey="Valiquette, L" sort="Valiquette, L" uniqKey="Valiquette L" first="L" last="Valiquette">L. Valiquette</name></author><author><name sortKey="Vanderkooi, O G" sort="Vanderkooi, O G" uniqKey="Vanderkooi O" first="O G" last="Vanderkooi">O G Vanderkooi</name></author><author><name sortKey="Kellner, J D" sort="Kellner, J D" uniqKey="Kellner J" first="J D" last="Kellner">J D Kellner</name></author><author><name sortKey="Coleman, B L" sort="Coleman, B L" uniqKey="Coleman B" first="B L" last="Coleman">B L Coleman</name></author><author><name sortKey="Mcneil, S A" sort="Mcneil, S A" uniqKey="Mcneil S" first="S A" last="Mcneil">S A Mcneil</name></author><author><name sortKey="Mccarthy, A" sort="Mccarthy, A" uniqKey="Mccarthy A" first="A" last="Mccarthy">A. Mccarthy</name></author><author><name sortKey="De Serres, G" sort="De Serres, G" uniqKey="De Serres G" first="G" last="De Serres">G. De Serres</name></author></analytic><series><title level="j">Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin</title><idno type="eISSN">1560-7917</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Adverse Drug Reaction Reporting Systems</term><term>Aged</term><term>Canada (epidemiology)</term><term>Case-Control Studies</term><term>Epidemiological Monitoring</term><term>Female</term><term>Health Personnel</term><term>Humans</term><term>Immunization (adverse effects)</term><term>Influenza A Virus, H1N1 Subtype (immunology)</term><term>Influenza Vaccines (administration & dosage)</term><term>Influenza Vaccines (adverse effects)</term><term>Influenza, Human (epidemiology)</term><term>Influenza, Human (prevention & control)</term><term>Male</term><term>Middle Aged</term><term>Population Surveillance (methods)</term><term>Program Evaluation</term><term>Surveys and Questionnaires</term><term>Vaccination (methods)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Canada (épidémiologie)</term><term>Enquêtes et questionnaires</term><term>Femelle</term><term>Grippe humaine ()</term><term>Grippe humaine (épidémiologie)</term><term>Humains</term><term>Immunisation (effets indésirables)</term><term>Mâle</term><term>Personnel de santé</term><term>Sous-type H1N1 du virus de la grippe A (immunologie)</term><term>Sujet âgé</term><term>Surveillance de la population ()</term><term>Systèmes de signalement des effets indésirables des médicaments</term><term>Vaccination ()</term><term>Vaccins antigrippaux (administration et posologie)</term><term>Vaccins antigrippaux (effets indésirables)</term><term>Épidémiosurveillance</term><term>Études cas-témoins</term><term>Évaluation de programme</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>Canada</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Immunization</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Immunisation</term><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Sous-type H1N1 du virus de la grippe A</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza A Virus, H1N1 Subtype</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Population Surveillance</term><term>Vaccination</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Canada</term><term>Grippe humaine</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Adverse Drug Reaction Reporting Systems</term><term>Aged</term><term>Case-Control Studies</term><term>Epidemiological Monitoring</term><term>Female</term><term>Health Personnel</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Program Evaluation</term><term>Surveys and Questionnaires</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Enquêtes et questionnaires</term><term>Femelle</term><term>Grippe humaine</term><term>Humains</term><term>Mâle</term><term>Personnel de santé</term><term>Sujet âgé</term><term>Surveillance de la population</term><term>Systèmes de signalement des effets indésirables des médicaments</term><term>Vaccination</term><term>Épidémiosurveillance</term><term>Études cas-témoins</term><term>Évaluation de programme</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Canada</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In 2011 and 2012, a nationwide Canadian vaccine safety surveillance network rapidly collected safety data from healthcare workers (HCW) during the first weeks of the annual influenza vaccination campaign. This network provided the first available post-marketing safety data on seasonal influenza vaccines with information on background rates as a comparator. In 2012, these data were used to investigate a possible safety concern regarding a particular vaccine. An online questionnaire was provided to participating HCW two weeks before the annual influenza vaccination campaign for controls, and eight days after influenza vaccination for vaccinees. Control and vaccinees were requested to report health events occurring in the seven days prior to receiving the questionnaire. Control data were used to calculate background rates. HCW reporting a severe event were followed-up by telephone within 48 hours of the online report to validate the report and check on their health status. More than 22,000 vaccinated HCW were enrolled and surveyed over two seasons and > 90% reported no severe event following vaccination. Validated severe event rates were similar in vaccinated HCW and unvaccinated HCW (2.2% vs 2.3%; p < 0.70). The questionnaire was accurately completed for most reported symptoms, matched the validated report and was able to detect events of interest. Prior to the safety concern, the implicated vaccine was in use at one centre. Reassuring safety data were provided to public health authorities 48 hours after the vaccine was temporarily suspended. Data from this and similar networks can be used for rapid evaluation of vaccine safety and for safety assessment as required by the European Medicines Agency in 2015.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26227369</PMID><DateCompleted><Year>2015</Year><Month>11</Month><Day>13</Day></DateCompleted><DateRevised><Year>2019</Year><Month>06</Month><Day>09</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1560-7917</ISSN><JournalIssue CitedMedium="Internet"><Volume>20</Volume><Issue>29</Issue><PubDate><Year>2015</Year><Month>Jul</Month><Day>23</Day></PubDate></JournalIssue><Title>Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin</Title><ISOAbbreviation>Euro Surveill.</ISOAbbreviation></Journal><ArticleTitle>Successful methodology for large-scale surveillance of severe events following influenza vaccination in Canada, 2011 and 2012.</ArticleTitle><Pagination><MedlinePgn>21189</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">21189</ELocationID><Abstract><AbstractText>In 2011 and 2012, a nationwide Canadian vaccine safety surveillance network rapidly collected safety data from healthcare workers (HCW) during the first weeks of the annual influenza vaccination campaign. This network provided the first available post-marketing safety data on seasonal influenza vaccines with information on background rates as a comparator. In 2012, these data were used to investigate a possible safety concern regarding a particular vaccine. An online questionnaire was provided to participating HCW two weeks before the annual influenza vaccination campaign for controls, and eight days after influenza vaccination for vaccinees. Control and vaccinees were requested to report health events occurring in the seven days prior to receiving the questionnaire. Control data were used to calculate background rates. HCW reporting a severe event were followed-up by telephone within 48 hours of the online report to validate the report and check on their health status. More than 22,000 vaccinated HCW were enrolled and surveyed over two seasons and > 90% reported no severe event following vaccination. Validated severe event rates were similar in vaccinated HCW and unvaccinated HCW (2.2% vs 2.3%; p < 0.70). The questionnaire was accurately completed for most reported symptoms, matched the validated report and was able to detect events of interest. Prior to the safety concern, the implicated vaccine was in use at one centre. Reassuring safety data were provided to public health authorities 48 hours after the vaccine was temporarily suspended. Data from this and similar networks can be used for rapid evaluation of vaccine safety and for safety assessment as required by the European Medicines Agency in 2015.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Bettinger</LastName><ForeName>J A</ForeName><Initials>JA</Initials><AffiliationInfo><Affiliation>Vaccine Evaluation Center, BC Children's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rouleau</LastName><ForeName>I</ForeName><Initials>I</Initials></Author><Author ValidYN="Y"><LastName>Gariepy</LastName><ForeName>M C</ForeName><Initials>MC</Initials></Author><Author ValidYN="Y"><LastName>Bowie</LastName><ForeName>W R</ForeName><Initials>WR</Initials></Author><Author ValidYN="Y"><LastName>Valiquette</LastName><ForeName>L</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Vanderkooi</LastName><ForeName>O G</ForeName><Initials>OG</Initials></Author><Author ValidYN="Y"><LastName>Kellner</LastName><ForeName>J D</ForeName><Initials>JD</Initials></Author><Author ValidYN="Y"><LastName>Coleman</LastName><ForeName>B L</ForeName><Initials>BL</Initials></Author><Author ValidYN="Y"><LastName>McNeil</LastName><ForeName>S A</ForeName><Initials>SA</Initials></Author><Author ValidYN="Y"><LastName>McCarthy</LastName><ForeName>A</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>De Serres</LastName><ForeName>G</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><CollectiveName>Public Health Agency of Canada/Canadian Institutes for Health Research Influenza Research Network</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>07</Month><Day>23</Day></ArticleDate></Article><MedlineJournalInfo><Country>Sweden</Country><MedlineTA>Euro Surveill</MedlineTA><NlmUniqueID>100887452</NlmUniqueID><ISSNLinking>1025-496X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016907" MajorTopicYN="Y">Adverse Drug Reaction Reporting Systems</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002170" MajorTopicYN="N" Type="Geographic">Canada</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016022" MajorTopicYN="N">Case-Control Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D062665" MajorTopicYN="N">Epidemiological Monitoring</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006282" MajorTopicYN="N">Health Personnel</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007114" MajorTopicYN="N">Immunization</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D053118" MajorTopicYN="N">Influenza A Virus, H1N1 Subtype</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011159" MajorTopicYN="N">Population Surveillance</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015397" MajorTopicYN="N">Program Evaluation</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011795" MajorTopicYN="N">Surveys and Questionnaires</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014611" MajorTopicYN="N">Vaccination</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>8</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>8</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>11</Month><Day>14</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26227369</ArticleId><ArticleId IdType="doi">10.2807/1560-7917.es2015.20.29.21189</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Canada</li></country></list><tree><noCountry><name sortKey="Bowie, W R" sort="Bowie, W R" uniqKey="Bowie W" first="W R" last="Bowie">W R Bowie</name><name sortKey="Coleman, B L" sort="Coleman, B L" uniqKey="Coleman B" first="B L" last="Coleman">B L Coleman</name><name sortKey="De Serres, G" sort="De Serres, G" uniqKey="De Serres G" first="G" last="De Serres">G. De Serres</name><name sortKey="Gariepy, M C" sort="Gariepy, M C" uniqKey="Gariepy M" first="M C" last="Gariepy">M C Gariepy</name><name sortKey="Kellner, J D" sort="Kellner, J D" uniqKey="Kellner J" first="J D" last="Kellner">J D Kellner</name><name sortKey="Mccarthy, A" sort="Mccarthy, A" uniqKey="Mccarthy A" first="A" last="Mccarthy">A. Mccarthy</name><name sortKey="Mcneil, S A" sort="Mcneil, S A" uniqKey="Mcneil S" first="S A" last="Mcneil">S A Mcneil</name><name sortKey="Rouleau, I" sort="Rouleau, I" uniqKey="Rouleau I" first="I" last="Rouleau">I. Rouleau</name><name sortKey="Valiquette, L" sort="Valiquette, L" uniqKey="Valiquette L" first="L" last="Valiquette">L. Valiquette</name><name sortKey="Vanderkooi, O G" sort="Vanderkooi, O G" uniqKey="Vanderkooi O" first="O G" last="Vanderkooi">O G Vanderkooi</name></noCountry><country name="Canada"><noRegion><name sortKey="Bettinger, J A" sort="Bettinger, J A" uniqKey="Bettinger J" first="J A" last="Bettinger">J A Bettinger</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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