Rapid assessment of the reactogenicity of a 2016-2017 seasonal influenza vaccine: results from a feasibility study.
Identifieur interne : 000015 ( Main/Exploration ); précédent : 000014; suivant : 000016Rapid assessment of the reactogenicity of a 2016-2017 seasonal influenza vaccine: results from a feasibility study.
Auteurs : Anke L. Stuurman [Belgique] ; Thomas Verstraeten [Belgique] ; Antoon De Schryver [Belgique]Source :
- Expert review of vaccines [ 1744-8395 ] ; 2017.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Belgique, Effets secondaires indésirables des médicaments (anatomopathologie), Effets secondaires indésirables des médicaments (épidémiologie), Enquêtes et questionnaires, Envoi de messages textuels, Facteurs temps, Femelle, Grippe humaine (), Humains, Jeune adulte, Mâle, Sujet âgé, Surveillance post-commercialisation des produits de santé (), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Études de faisabilité.
- MESH :
- administration et posologie : Vaccins antigrippaux.
- anatomopathologie : Effets secondaires indésirables des médicaments.
- effets indésirables : Vaccins antigrippaux.
- épidémiologie : Effets secondaires indésirables des médicaments.
- Adolescent, Adulte, Adulte d'âge moyen, Belgique, Enquêtes et questionnaires, Envoi de messages textuels, Facteurs temps, Femelle, Grippe humaine, Humains, Jeune adulte, Mâle, Sujet âgé, Surveillance post-commercialisation des produits de santé, Études de faisabilité.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Belgium, Drug-Related Side Effects and Adverse Reactions (epidemiology), Drug-Related Side Effects and Adverse Reactions (pathology), Feasibility Studies, Female, Humans, Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza, Human (prevention & control), Male, Middle Aged, Product Surveillance, Postmarketing (methods), Surveys and Questionnaires, Text Messaging, Time Factors, Young Adult.
- MESH :
- chemical , administration & dosage : Influenza Vaccines.
- chemical , adverse effects : Influenza Vaccines.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- methods : Product Surveillance, Postmarketing.
- pathology : Drug-Related Side Effects and Adverse Reactions.
- prevention & control : Influenza, Human.
- Adolescent, Adult, Aged, Belgium, Feasibility Studies, Female, Humans, Male, Middle Aged, Surveys and Questionnaires, Text Messaging, Time Factors, Young Adult.
Abstract
BACKGROUND
The European Medicines Agency (EMA) calls for a strategy for enhanced safety surveillance of seasonal influenza vaccines.
OBJECTIVE
We assessed the feasibility of collecting reactogenicity data within one month of the start of the vaccination campaign in Belgium.
METHODS
One hundred subjects aged 18 to 65 years who had received inactivated seasonal influenza vaccine in occupational setting were enrolled. For 7 days after vaccination, subjects received a daily SMS with a link to a web-based questionnaire where reactogenicity events and their severity were solicited.
RESULTS
Data collection was completed by October 13th, 2016, before the peak of the vaccination campaign in Belgium. 68% of participants reported a local reaction and 65% a general reaction; 51% reported both a local and a general reaction.
CONCLUSION
Here we show that it has been possible to collect reactogenicity data in adults for enhanced safety surveillance in Belgium in a timely manner. The observed reactogenicity is higher compared to previous observations for this vaccine measured in clinical trials.
DOI: 10.1080/14760584.2017.1264272
PubMed: 27882801
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Stuurman</name><affiliation wicri:level="1"><nlm:affiliation>a P95 Epidemiology and Pharmacovigilance Consulting and Services , Leuven , Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>a P95 Epidemiology and Pharmacovigilance Consulting and Services , Leuven </wicri:regionArea><wicri:noRegion>Leuven </wicri:noRegion></affiliation></author><author><name sortKey="Verstraeten, Thomas" sort="Verstraeten, Thomas" uniqKey="Verstraeten T" first="Thomas" last="Verstraeten">Thomas Verstraeten</name><affiliation wicri:level="1"><nlm:affiliation>a P95 Epidemiology and Pharmacovigilance Consulting and Services , Leuven , Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>a P95 Epidemiology and Pharmacovigilance Consulting and Services , Leuven </wicri:regionArea><wicri:noRegion>Leuven </wicri:noRegion></affiliation></author><author><name sortKey="De Schryver, Antoon" sort="De Schryver, Antoon" uniqKey="De Schryver A" first="Antoon" last="De Schryver">Antoon De Schryver</name><affiliation wicri:level="1"><nlm:affiliation>b IDEWE Occupational Health Services , Leuven , Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>b IDEWE Occupational Health Services , Leuven </wicri:regionArea><wicri:noRegion>Leuven </wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:27882801</idno><idno type="pmid">27882801</idno><idno type="doi">10.1080/14760584.2017.1264272</idno><idno type="wicri:Area/Main/Corpus">000018</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000018</idno><idno type="wicri:Area/Main/Curation">000018</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000018</idno><idno type="wicri:Area/Main/Exploration">000018</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Rapid assessment of the reactogenicity of a 2016-2017 seasonal influenza vaccine: results from a feasibility study.</title><author><name sortKey="Stuurman, Anke L" sort="Stuurman, Anke L" uniqKey="Stuurman A" first="Anke L" last="Stuurman">Anke L. Stuurman</name><affiliation wicri:level="1"><nlm:affiliation>a P95 Epidemiology and Pharmacovigilance Consulting and Services , Leuven , Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>a P95 Epidemiology and Pharmacovigilance Consulting and Services , Leuven </wicri:regionArea><wicri:noRegion>Leuven </wicri:noRegion></affiliation></author><author><name sortKey="Verstraeten, Thomas" sort="Verstraeten, Thomas" uniqKey="Verstraeten T" first="Thomas" last="Verstraeten">Thomas Verstraeten</name><affiliation wicri:level="1"><nlm:affiliation>a P95 Epidemiology and Pharmacovigilance Consulting and Services , Leuven , Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>a P95 Epidemiology and Pharmacovigilance Consulting and Services , Leuven </wicri:regionArea><wicri:noRegion>Leuven </wicri:noRegion></affiliation></author><author><name sortKey="De Schryver, Antoon" sort="De Schryver, Antoon" uniqKey="De Schryver A" first="Antoon" last="De Schryver">Antoon De Schryver</name><affiliation wicri:level="1"><nlm:affiliation>b IDEWE Occupational Health Services , Leuven , Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>b IDEWE Occupational Health Services , Leuven </wicri:regionArea><wicri:noRegion>Leuven </wicri:noRegion></affiliation></author></analytic><series><title level="j">Expert review of vaccines</title><idno type="eISSN">1744-8395</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Belgium</term><term>Drug-Related Side Effects and Adverse Reactions (epidemiology)</term><term>Drug-Related Side Effects and Adverse Reactions (pathology)</term><term>Feasibility Studies</term><term>Female</term><term>Humans</term><term>Influenza Vaccines (administration & dosage)</term><term>Influenza Vaccines (adverse effects)</term><term>Influenza, Human (prevention & control)</term><term>Male</term><term>Middle Aged</term><term>Product Surveillance, Postmarketing (methods)</term><term>Surveys and Questionnaires</term><term>Text Messaging</term><term>Time Factors</term><term>Young Adult</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Belgique</term><term>Effets secondaires indésirables des médicaments (anatomopathologie)</term><term>Effets secondaires indésirables des médicaments (épidémiologie)</term><term>Enquêtes et questionnaires</term><term>Envoi de messages textuels</term><term>Facteurs temps</term><term>Femelle</term><term>Grippe humaine ()</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Sujet âgé</term><term>Surveillance post-commercialisation des produits de santé ()</term><term>Vaccins antigrippaux (administration et posologie)</term><term>Vaccins antigrippaux (effets indésirables)</term><term>Études de faisabilité</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" qualifier="administration et posologie" xml:lang="fr"><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Effets secondaires indésirables des médicaments</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Product Surveillance, Postmarketing</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</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>Effets secondaires indésirables des médicaments</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Belgium</term><term>Feasibility Studies</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Surveys and Questionnaires</term><term>Text Messaging</term><term>Time Factors</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Belgique</term><term>Enquêtes et questionnaires</term><term>Envoi de messages textuels</term><term>Facteurs temps</term><term>Femelle</term><term>Grippe humaine</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Sujet âgé</term><term>Surveillance post-commercialisation des produits de santé</term><term>Études de faisabilité</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>The European Medicines Agency (EMA) calls for a strategy for enhanced safety surveillance of seasonal influenza vaccines.</p></div><div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b></p><p>We assessed the feasibility of collecting reactogenicity data within one month of the start of the vaccination campaign in Belgium.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>One hundred subjects aged 18 to 65 years who had received inactivated seasonal influenza vaccine in occupational setting were enrolled. For 7 days after vaccination, subjects received a daily SMS with a link to a web-based questionnaire where reactogenicity events and their severity were solicited.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Data collection was completed by October 13th, 2016, before the peak of the vaccination campaign in Belgium. 68% of participants reported a local reaction and 65% a general reaction; 51% reported both a local and a general reaction.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSION</b></p><p>Here we show that it has been possible to collect reactogenicity data in adults for enhanced safety surveillance in Belgium in a timely manner. The observed reactogenicity is higher compared to previous observations for this vaccine measured in clinical trials.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27882801</PMID><DateCompleted><Year>2017</Year><Month>07</Month><Day>31</Day></DateCompleted><DateRevised><Year>2018</Year><Month>02</Month><Day>18</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1744-8395</ISSN><JournalIssue CitedMedium="Internet"><Volume>16</Volume><Issue>2</Issue><PubDate><Year>2017</Year><Month>02</Month></PubDate></JournalIssue><Title>Expert review of vaccines</Title><ISOAbbreviation>Expert Rev Vaccines</ISOAbbreviation></Journal><ArticleTitle>Rapid assessment of the reactogenicity of a 2016-2017 seasonal influenza vaccine: results from a feasibility study.</ArticleTitle><Pagination><MedlinePgn>187-191</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1080/14760584.2017.1264272</ELocationID><Abstract><AbstractText Label="BACKGROUND">The European Medicines Agency (EMA) calls for a strategy for enhanced safety surveillance of seasonal influenza vaccines.</AbstractText><AbstractText Label="OBJECTIVE">We assessed the feasibility of collecting reactogenicity data within one month of the start of the vaccination campaign in Belgium.</AbstractText><AbstractText Label="METHODS">One hundred subjects aged 18 to 65 years who had received inactivated seasonal influenza vaccine in occupational setting were enrolled. For 7 days after vaccination, subjects received a daily SMS with a link to a web-based questionnaire where reactogenicity events and their severity were solicited.</AbstractText><AbstractText Label="RESULTS">Data collection was completed by October 13th, 2016, before the peak of the vaccination campaign in Belgium. 68% of participants reported a local reaction and 65% a general reaction; 51% reported both a local and a general reaction.</AbstractText><AbstractText Label="CONCLUSION">Here we show that it has been possible to collect reactogenicity data in adults for enhanced safety surveillance in Belgium in a timely manner. The observed reactogenicity is higher compared to previous observations for this vaccine measured in clinical trials.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Stuurman</LastName><ForeName>Anke L</ForeName><Initials>AL</Initials><AffiliationInfo><Affiliation>a P95 Epidemiology and Pharmacovigilance Consulting and Services , Leuven , Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Verstraeten</LastName><ForeName>Thomas</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>a P95 Epidemiology and Pharmacovigilance Consulting and Services , Leuven , Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>De Schryver</LastName><ForeName>Antoon</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>b IDEWE Occupational Health Services , Leuven , Belgium.</Affiliation></AffiliationInfo></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>2016</Year><Month>12</Month><Day>01</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Expert Rev Vaccines</MedlineTA><NlmUniqueID>101155475</NlmUniqueID><ISSNLinking>1476-0584</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D001530" MajorTopicYN="N">Belgium</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D064420" MajorTopicYN="N">Drug-Related Side Effects and Adverse Reactions</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="Y">epidemiology</QualifierName><QualifierName UI="Q000473" MajorTopicYN="Y">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005240" MajorTopicYN="N">Feasibility Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName><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="D011358" MajorTopicYN="N">Product Surveillance, Postmarketing</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011795" MajorTopicYN="N">Surveys and Questionnaires</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D060145" MajorTopicYN="N">Text Messaging</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">Adults</Keyword><Keyword MajorTopicYN="Y">European Medicines Agency guidance</Keyword><Keyword MajorTopicYN="Y">enhanced safety surveillance</Keyword><Keyword MajorTopicYN="Y">reactogenicity</Keyword><Keyword MajorTopicYN="Y">seasonal influenza vaccine</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>11</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>8</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>11</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27882801</ArticleId><ArticleId IdType="doi">10.1080/14760584.2017.1264272</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Belgique</li></country></list><tree><country name="Belgique"><noRegion><name sortKey="Stuurman, Anke L" sort="Stuurman, Anke L" uniqKey="Stuurman A" first="Anke L" last="Stuurman">Anke L. Stuurman</name></noRegion><name sortKey="De Schryver, Antoon" sort="De Schryver, Antoon" uniqKey="De Schryver A" first="Antoon" last="De Schryver">Antoon De Schryver</name><name sortKey="Verstraeten, Thomas" sort="Verstraeten, Thomas" uniqKey="Verstraeten T" first="Thomas" last="Verstraeten">Thomas Verstraeten</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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