An early (3-6 weeks) active surveillance study to assess the safety of pandemic influenza vaccine Focetria in a province of Emilia-Romagna region, Italy - part one.
Identifieur interne : 001408 ( Ncbi/Merge ); précédent : 001407; suivant : 001409An early (3-6 weeks) active surveillance study to assess the safety of pandemic influenza vaccine Focetria in a province of Emilia-Romagna region, Italy - part one.
Auteurs : Silvia Candela [Italie] ; Sara Pergolizzi ; Pietro Ragni ; Silvio Cavuto ; Lucia Nobilio ; Simona Di Mario ; Valentina Dragosevic ; Nicola Groth ; Nicola MagriniSource :
- Vaccine [ 1873-2518 ] ; 2013.
Descripteurs français
- KwdFr :
- Adjuvants immunologiques (administration et posologie), Adolescent, Adulte, Adulte d'âge moyen, Effets secondaires indésirables des médicaments (anatomopathologie), Effets secondaires indésirables des médicaments (épidémiologie), Enfant, Enfant d'âge préscolaire, Femelle, Grossesse, Humains, Italie, Jeune adulte, Mâle, Nourrisson, Polysorbates (administration et posologie), Sous-type H1N1 du virus de la grippe A (immunologie), Squalène (administration et posologie), Sujet âgé, Sujet âgé de 80 ans ou plus, Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie), Études prospectives.
- MESH :
- administration et posologie : Adjuvants immunologiques, Polysorbates, Squalène, Vaccins antigrippaux.
- anatomopathologie : Effets secondaires indésirables des médicaments.
- effets indésirables : Vaccins antigrippaux.
- immunologie : Sous-type H1N1 du virus de la grippe A, Vaccins antigrippaux.
- épidémiologie : Effets secondaires indésirables des médicaments.
- Adolescent, Adulte, Adulte d'âge moyen, Enfant, Enfant d'âge préscolaire, Femelle, Grossesse, Humains, Italie, Jeune adulte, Mâle, Nourrisson, Sujet âgé, Sujet âgé de 80 ans ou plus, Études prospectives.
- Wicri :
- geographic : Italie.
English descriptors
- KwdEn :
- Adjuvants, Immunologic (administration & dosage), Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Drug-Related Side Effects and Adverse Reactions (epidemiology), Drug-Related Side Effects and Adverse Reactions (pathology), Female, Humans, Infant, Influenza A Virus, H1N1 Subtype (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Italy, Male, Middle Aged, Polysorbates (administration & dosage), Pregnancy, Prospective Studies, Squalene (administration & dosage), Young Adult.
- MESH :
- chemical , administration & dosage : Adjuvants, Immunologic, Influenza Vaccines, Polysorbates, Squalene.
- chemical , adverse effects : Influenza Vaccines.
- geographic : Italy.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- immunology : Influenza A Virus, H1N1 Subtype, Influenza Vaccines.
- pathology : Drug-Related Side Effects and Adverse Reactions.
- Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Female, Humans, Infant, Male, Middle Aged, Pregnancy, Prospective Studies, Young Adult.
Abstract
An observational, non-comparative, prospective, surveillance study of individuals vaccinated with the MF59-adjuvanted A/H1N1 influenza vaccine, Focetria, (Novartis Vaccines & Diagnostics, Siena, Italy), was performed in Italy during the 2009 A/H1N1 influenza pandemic.
DOI: 10.1016/j.vaccine.2012.06.030
PubMed: 22766247
Links toward previous steps (curation, corpus...)
- to stream PubMed, to step Corpus: 000C63
- to stream PubMed, to step Curation: 000C63
- to stream PubMed, to step Checkpoint: 000A76
Links to Exploration step
pubmed:22766247Le document en format XML
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xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Enfant</term><term>Enfant d'âge préscolaire</term><term>Femelle</term><term>Grossesse</term><term>Humains</term><term>Italie</term><term>Jeune adulte</term><term>Mâle</term><term>Nourrisson</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Études prospectives</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Italie</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">An observational, non-comparative, prospective, surveillance study of individuals vaccinated with the MF59-adjuvanted A/H1N1 influenza vaccine, Focetria, (Novartis Vaccines & Diagnostics, Siena, Italy), was performed in Italy during the 2009 A/H1N1 influenza pandemic.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">22766247</PMID><DateCompleted><Year>2013</Year><Month>08</Month><Day>12</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN><JournalIssue CitedMedium="Internet"><Volume>31</Volume><Issue>10</Issue><PubDate><Year>2013</Year><Month>Feb</Month><Day>27</Day></PubDate></JournalIssue><Title>Vaccine</Title><ISOAbbreviation>Vaccine</ISOAbbreviation></Journal><ArticleTitle>An early (3-6 weeks) active surveillance study to assess the safety of pandemic influenza vaccine Focetria in a province of Emilia-Romagna region, Italy - part one.</ArticleTitle><Pagination><MedlinePgn>1431-7</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2012.06.030</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S0264-410X(12)00884-5</ELocationID><Abstract><AbstractText Label="INTRODUCTION" NlmCategory="BACKGROUND">An observational, non-comparative, prospective, surveillance study of individuals vaccinated with the MF59-adjuvanted A/H1N1 influenza vaccine, Focetria, (Novartis Vaccines & Diagnostics, Siena, Italy), was performed in Italy during the 2009 A/H1N1 influenza pandemic.</AbstractText><AbstractText Label="METHOD" NlmCategory="METHODS">This study assessed the short-term (six-week) safety profile of the investigational vaccine in real time. After vaccination (N=7943), adverse events (AE) were assessed using both active (telephone) and passive (healthcare database) follow-up in enrolled vaccinated subjects, including infants (6-23 months), pregnant women, and the immunosuppressed. The treating physicians of all subjects experiencing AEs post-vaccination were consulted for clinical information on the conditions reported. All AEs were coded according to ICD-10.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">A total of 1583 AEs occurred during the study, 67 (4.2%) of which were serious adverse events (SAEs). One SAE was considered to be possibly related to vaccination (transitory and ill-defined neurologic disorder experienced by a 16-year-old asthmatic male). Three adverse events of special interest (AESI) were identified (convulsions experienced by two epileptic subjects), none of which were considered to be vaccine-related. Six individuals died during the study period, in each case the cause of death was not related to vaccination (four cases of severe underlying co-morbidity, one case of psychoactive drug misuse, and one case of acute myocardial infarction).</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">No cases of clinically relevant AEs, SAEs, or AESI were observed within a six-week period of vaccine administration. In accordance with existing clinical and post-marketing safety data, the results of this active surveillance study demonstrate a good safety profile for the MF59-adjuvanted A/H1N1 vaccine, Focetria, within the general population.</AbstractText><CopyrightInformation>Copyright © 2012 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Candela</LastName><ForeName>Silvia</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Servizio di Epidemiologia, Dipartimento di Sanità Pubblica, Azienda USL di Reggio Emilia, Via Amendola 2, 42122 Reggio Emilia, Italy. silvia.candela@gmail.com</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pergolizzi</LastName><ForeName>Sara</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Ragni</LastName><ForeName>Pietro</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Cavuto</LastName><ForeName>Silvio</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Nobilio</LastName><ForeName>Lucia</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Di Mario</LastName><ForeName>Simona</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Dragosevic</LastName><ForeName>Valentina</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Groth</LastName><ForeName>Nicola</ForeName><Initials>N</Initials></Author><Author ValidYN="Y"><LastName>Magrini</LastName><ForeName>Nicola</ForeName><Initials>N</Initials></Author><Author ValidYN="Y"><CollectiveName>SaFoH1N1 working group</CollectiveName></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01101074</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2012</Year><Month>07</Month><Day>02</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Vaccine</MedlineTA><NlmUniqueID>8406899</NlmUniqueID><ISSNLinking>0264-410X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000276">Adjuvants, Immunologic</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C089950">MF59 oil emulsion</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011136">Polysorbates</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C558220">focetria</NameOfSubstance></Chemical><Chemical><RegistryNumber>7QWM220FJH</RegistryNumber><NameOfSubstance UI="D013185">Squalene</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000276" MajorTopicYN="N">Adjuvants, Immunologic</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><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="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002675" MajorTopicYN="N">Child, Preschool</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="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007223" MajorTopicYN="N">Infant</DescriptorName></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="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007558" MajorTopicYN="N" Type="Geographic">Italy</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011136" MajorTopicYN="N">Polysorbates</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011247" MajorTopicYN="N">Pregnancy</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011446" MajorTopicYN="N">Prospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013185" MajorTopicYN="N">Squalene</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><InvestigatorList><Investigator ValidYN="Y"><LastName>Broccoli</LastName><ForeName>Serena</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Candela</LastName><ForeName>Silvia</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Cavuto</LastName><ForeName>Silvio</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Pergolizzi</LastName><ForeName>Sara</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Ragni</LastName><ForeName>Pietro</ForeName><Initials>P</Initials></Investigator><Investigator ValidYN="Y"><LastName>Moro</LastName><ForeName>Maria Luisa</ForeName><Initials>ML</Initials></Investigator><Investigator ValidYN="Y"><LastName>Nobilio</LastName><ForeName>Lucia</ForeName><Initials>L</Initials></Investigator><Investigator ValidYN="Y"><LastName>Di Mario</LastName><ForeName>Simona</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Magrini</LastName><ForeName>Nicola</ForeName><Initials>N</Initials></Investigator><Investigator ValidYN="Y"><LastName>Voci</LastName><ForeName>Claudio</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>Della Cioppa</LastName><ForeName>Giovanni</ForeName><Initials>G</Initials></Investigator><Investigator ValidYN="Y"><LastName>Dragosevic</LastName><ForeName>Valentina</ForeName><Initials>V</Initials></Investigator><Investigator ValidYN="Y"><LastName>Groth</LastName><ForeName>Nicola</ForeName><Initials>N</Initials></Investigator><Investigator ValidYN="Y"><LastName>Lattanzi</LastName><ForeName>Maria</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Taddei</LastName><ForeName>Laura</ForeName><Initials>L</Initials></Investigator><Investigator ValidYN="Y"><LastName>Apolone</LastName><ForeName>Giovanni</ForeName><Initials>G</Initials></Investigator><Investigator ValidYN="Y"><LastName>Candela</LastName><ForeName>Silvia</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Ciofi degli Atti</LastName><ForeName>Marta Luisa</ForeName><Initials>ML</Initials></Investigator><Investigator ValidYN="Y"><LastName>Grilli</LastName><ForeName>Roberto</ForeName><Initials>R</Initials></Investigator><Investigator ValidYN="Y"><LastName>Magrini</LastName><ForeName>Nicola</ForeName><Initials>N</Initials></Investigator><Investigator ValidYN="Y"><LastName>Mannino</LastName><ForeName>Salvatore</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Moro</LastName><ForeName>Maria Luisa</ForeName><Initials>ML</Initials></Investigator><Investigator ValidYN="Y"><LastName>Riccò</LastName><ForeName>Daniela</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Garattini</LastName><ForeName>Silvio</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Rezza</LastName><ForeName>Giovanni</ForeName><Initials>G</Initials></Investigator><Investigator ValidYN="Y"><LastName>Macini</LastName><ForeName>Pierluigi</ForeName><Initials>P</Initials></Investigator></InvestigatorList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2012</Year><Month>03</Month><Day>06</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2012</Year><Month>06</Month><Day>08</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2012</Year><Month>06</Month><Day>11</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2012</Year><Month>7</Month><Day>7</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2012</Year><Month>7</Month><Day>7</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2013</Year><Month>8</Month><Day>13</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">22766247</ArticleId><ArticleId IdType="pii">S0264-410X(12)00884-5</ArticleId><ArticleId IdType="doi">10.1016/j.vaccine.2012.06.030</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Italie</li></country></list><tree><noCountry><name sortKey="Cavuto, Silvio" sort="Cavuto, Silvio" uniqKey="Cavuto S" first="Silvio" last="Cavuto">Silvio Cavuto</name><name sortKey="Di Mario, Simona" sort="Di Mario, Simona" uniqKey="Di Mario S" first="Simona" last="Di Mario">Simona Di Mario</name><name sortKey="Dragosevic, Valentina" sort="Dragosevic, Valentina" uniqKey="Dragosevic V" first="Valentina" last="Dragosevic">Valentina Dragosevic</name><name sortKey="Groth, Nicola" sort="Groth, Nicola" uniqKey="Groth N" first="Nicola" last="Groth">Nicola Groth</name><name sortKey="Magrini, Nicola" sort="Magrini, Nicola" uniqKey="Magrini N" first="Nicola" last="Magrini">Nicola Magrini</name><name sortKey="Nobilio, Lucia" sort="Nobilio, Lucia" uniqKey="Nobilio L" first="Lucia" last="Nobilio">Lucia Nobilio</name><name sortKey="Pergolizzi, Sara" sort="Pergolizzi, Sara" uniqKey="Pergolizzi S" first="Sara" last="Pergolizzi">Sara Pergolizzi</name><name sortKey="Ragni, Pietro" sort="Ragni, Pietro" uniqKey="Ragni P" first="Pietro" last="Ragni">Pietro Ragni</name></noCountry><country name="Italie"><noRegion><name sortKey="Candela, Silvia" sort="Candela, Silvia" uniqKey="Candela S" first="Silvia" last="Candela">Silvia Candela</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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