GrippeBresilV2, Main, Exploration, bibRecord, 000050

Safety assessment of seasonal trivalent influenza vaccine produced by Instituto Butantan from 2013 to 2017.

Identifieur interne : 000050 ( Main/Exploration ); précédent : 000049; suivant : 000051

Safety assessment of seasonal trivalent influenza vaccine produced by Instituto Butantan from 2013 to 2017.

Auteurs : Vera Lúcia Gattás [Brésil] ; Patrícia Emília Braga [Brésil] ; Marcelo Eiji Koike [Brésil] ; Maria Beatriz Bastos Lucchesi [Brésil] ; Mayra Martho Moura De Oliveira [Brésil] ; Roberta De Oliveira Piorelli [Brésil] ; Vivian Queiroz [Brésil] ; Alexander Roberto Precioso [Brésil]

Source :

Revista do Instituto de Medicina Tropical de Sao Paulo [ 1678-9946 ] ; 2018.

RBID : pubmed:30570077

Descripteurs français

KwdFr :
- Adolescent (MeSH), Adulte (MeSH), Adulte d'âge moyen (MeSH), Brésil (MeSH), Enfant (MeSH), Enfant d'âge préscolaire (MeSH), Femelle (MeSH), Grippe humaine (prévention et contrôle), Grossesse (MeSH), Humains (MeSH), Jeune adulte (MeSH), Mâle (MeSH), Nourrisson (MeSH), Nouveau-né (MeSH), Saisons (MeSH), Sujet âgé (MeSH), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables).
MESH :
- administration et posologie : Vaccins antigrippaux.
- effets indésirables : Vaccins antigrippaux.
- prévention et contrôle : Grippe humaine.
- Adolescent, Adulte, Adulte d'âge moyen, Brésil, Enfant, Enfant d'âge préscolaire, Femelle, Grossesse, Humains, Jeune adulte, Mâle, Nourrisson, Nouveau-né, Saisons, Sujet âgé.
Wicri :
- geographic : Brésil.

English descriptors

KwdEn :
- Adolescent (MeSH), Adult (MeSH), Aged (MeSH), Brazil (MeSH), Child (MeSH), Child, Preschool (MeSH), Female (MeSH), Humans (MeSH), Infant (MeSH), Infant, Newborn (MeSH), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza, Human (prevention & control), Male (MeSH), Middle Aged (MeSH), Pregnancy (MeSH), Seasons (MeSH), Young Adult (MeSH).
MESH :
- chemical , administration & dosage : Influenza Vaccines.
- chemical , adverse effects : Influenza Vaccines.
- geographic : Brazil.
- prevention & control : Influenza, Human.
- Adolescent, Adult, Aged, Child, Child, Preschool, Female, Humans, Infant, Infant, Newborn, Male, Middle Aged, Pregnancy, Seasons, Young Adult.

Abstract

Vaccination has been a successful strategy in influenza prevention. However, despite the safety and efficacy of the vaccines, they can cause adverse events following immunization (AEFI). Moreover, due to the vaccination success, most of vaccine-preventable diseases (VPD) have become rare, and public attention has been shifted from VPD to the AEFI associated with vaccination. This manuscript describes the safety of Instituto Butantan (IB) seasonal trivalent influenza vaccine (TIV) from 2013 to 2017. AEFI data were received by the Department of Pharmacovigilance of IB (PV-IB), from January the 1st 2013 to December the 31st 2017, and were recorded in an electronic database (OpenClinica©). PV-IB received 1,415 Individual Case Safety Reports (ICSR) associated with the TIV; 1,253 ICSR with at least one AEFI were analyzed and 4,140 AEFI were identified. The other 162 (11.4%) cases did not present any symptom. Among the total of AEFI, 405 (9.8%) were classified as serious. AEFI with the highest incidence rates per 100,000 doses of TIV were: "local pain" (0.28), "local erythema" (0.23), "local warmth" (0.22), "local swelling" (0.20) and "fever" (0.19). PV-IB received 175 (4.2%) occurrences of SAE of special interest, of which 75 (1.8%) anaphylaxis/anaphylactic reactions, 56 (1.4%) neurological syndromes (including seven Guillain-Barré Syndrome) and 44 (1.1%) convulsion/febrile convulsion. The results of this manuscript suggested that Instituto Butantan trivalent influenza vaccine (IB-TIV) is safe, as most of the reported AEFI were classified as non-serious. AEFI described for the IB-TIV are in agreement with the ones described in the literature for similar vaccines.

DOI: 10.1590/S1678-9946201961004
PubMed: 30570077
PubMed Central: PMC6300789

Affiliations:

Links toward previous steps (curation, corpus...)

to stream Main, to step Corpus: 000034
to stream Main, to step Curation: 000034

Le document en format XML

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<term>Child, Preschool (MeSH)</term>
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<term>Influenza Vaccines (adverse effects)</term>
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<term>Enfant d'âge préscolaire (MeSH)</term>
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<term>Grippe humaine (prévention et contrôle)</term>
<term>Grossesse (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Jeune adulte (MeSH)</term>
<term>Mâle (MeSH)</term>
<term>Nourrisson (MeSH)</term>
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<term>Saisons (MeSH)</term>
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<front><div type="abstract" xml:lang="en">Vaccination has been a successful strategy in influenza prevention. However, despite the safety and efficacy of the vaccines, they can cause adverse events following immunization (AEFI). Moreover, due to the vaccination success, most of vaccine-preventable diseases (VPD) have become rare, and public attention has been shifted from VPD to the AEFI associated with vaccination. This manuscript describes the safety of Instituto Butantan (IB) seasonal trivalent influenza vaccine (TIV) from 2013 to 2017. AEFI data were received by the Department of Pharmacovigilance of IB (PV-IB), from January the 1st 2013 to December the 31st 2017, and were recorded in an electronic database (OpenClinica©). PV-IB received 1,415 Individual Case Safety Reports (ICSR) associated with the TIV; 1,253 ICSR with at least one AEFI were analyzed and 4,140 AEFI were identified. The other 162 (11.4%) cases did not present any symptom. Among the total of AEFI, 405 (9.8%) were classified as serious. AEFI with the highest incidence rates per 100,000 doses of TIV were: "local pain" (0.28), "local erythema" (0.23), "local warmth" (0.22), "local swelling" (0.20) and "fever" (0.19). PV-IB received 175 (4.2%) occurrences of SAE of special interest, of which 75 (1.8%) anaphylaxis/anaphylactic reactions, 56 (1.4%) neurological syndromes (including seven Guillain-Barré Syndrome) and 44 (1.1%) convulsion/febrile convulsion. The results of this manuscript suggested that Instituto Butantan trivalent influenza vaccine (IB-TIV) is safe, as most of the reported AEFI were classified as non-serious. AEFI described for the IB-TIV are in agreement with the ones described in the literature for similar vaccines.</div>
</front>
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<ELocationID EIdType="doi" ValidYN="Y">10.1590/S1678-9946201961004</ELocationID>
<Abstract><AbstractText>Vaccination has been a successful strategy in influenza prevention. However, despite the safety and efficacy of the vaccines, they can cause adverse events following immunization (AEFI). Moreover, due to the vaccination success, most of vaccine-preventable diseases (VPD) have become rare, and public attention has been shifted from VPD to the AEFI associated with vaccination. This manuscript describes the safety of Instituto Butantan (IB) seasonal trivalent influenza vaccine (TIV) from 2013 to 2017. AEFI data were received by the Department of Pharmacovigilance of IB (PV-IB), from January the 1st 2013 to December the 31st 2017, and were recorded in an electronic database (OpenClinica©). PV-IB received 1,415 Individual Case Safety Reports (ICSR) associated with the TIV; 1,253 ICSR with at least one AEFI were analyzed and 4,140 AEFI were identified. The other 162 (11.4%) cases did not present any symptom. Among the total of AEFI, 405 (9.8%) were classified as serious. AEFI with the highest incidence rates per 100,000 doses of TIV were: "local pain" (0.28), "local erythema" (0.23), "local warmth" (0.22), "local swelling" (0.20) and "fever" (0.19). PV-IB received 175 (4.2%) occurrences of SAE of special interest, of which 75 (1.8%) anaphylaxis/anaphylactic reactions, 56 (1.4%) neurological syndromes (including seven Guillain-Barré Syndrome) and 44 (1.1%) convulsion/febrile convulsion. The results of this manuscript suggested that Instituto Butantan trivalent influenza vaccine (IB-TIV) is safe, as most of the reported AEFI were classified as non-serious. AEFI described for the IB-TIV are in agreement with the ones described in the literature for similar vaccines.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Gattás</LastName>
<ForeName>Vera Lúcia</ForeName>
<Initials>VL</Initials>
<AffiliationInfo><Affiliation>Instituto Butantan, Divisão de Ensaios Clínicos e Farmacovigilância, São Paulo, São Paulo, Brazil.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Braga</LastName>
<ForeName>Patrícia Emília</ForeName>
<Initials>PE</Initials>
<AffiliationInfo><Affiliation>Instituto Butantan, Divisão de Ensaios Clínicos e Farmacovigilância, São Paulo, São Paulo, Brazil.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Koike</LastName>
<ForeName>Marcelo Eiji</ForeName>
<Initials>ME</Initials>
<AffiliationInfo><Affiliation>Instituto Butantan, Divisão de Ensaios Clínicos e Farmacovigilância, São Paulo, São Paulo, Brazil.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lucchesi</LastName>
<ForeName>Maria Beatriz Bastos</ForeName>
<Initials>MBB</Initials>
<AffiliationInfo><Affiliation>Instituto Butantan, Divisão de Ensaios Clínicos e Farmacovigilância, São Paulo, São Paulo, Brazil.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Oliveira</LastName>
<ForeName>Mayra Martho Moura de</ForeName>
<Initials>MMM</Initials>
<AffiliationInfo><Affiliation>Instituto Butantan, Divisão de Ensaios Clínicos e Farmacovigilância, São Paulo, São Paulo, Brazil.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Piorelli</LastName>
<ForeName>Roberta de Oliveira</ForeName>
<Initials>RO</Initials>
<AffiliationInfo><Affiliation>Instituto Butantan, Divisão de Ensaios Clínicos e Farmacovigilância, São Paulo, São Paulo, Brazil.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Queiroz</LastName>
<ForeName>Vivian</ForeName>
<Initials>V</Initials>
<AffiliationInfo><Affiliation>Instituto Butantan, Divisão de Ensaios Clínicos e Farmacovigilância, São Paulo, São Paulo, Brazil.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Precioso</LastName>
<ForeName>Alexander Roberto</ForeName>
<Initials>AR</Initials>
<AffiliationInfo><Affiliation>Instituto Butantan, Divisão de Ensaios Clínicos e Farmacovigilância, São Paulo, São Paulo, Brazil.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Universidade de São Paulo, Faculdade de Medicina, Departamento de Pediatria, São Paulo, São Paulo, Brazil.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT03057483</AccessionNumber>
</AccessionNumberList>
</DataBank>
</DataBankList>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016454">Review</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2018</Year>
<Month>12</Month>
<Day>20</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>Brazil</Country>
<MedlineTA>Rev Inst Med Trop Sao Paulo</MedlineTA>
<NlmUniqueID>7507484</NlmUniqueID>
<ISSNLinking>0036-4665</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="D001938" MajorTopicYN="N" Type="Geographic">Brazil</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D002675" MajorTopicYN="N">Child, Preschool</DescriptorName>
</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="D007231" MajorTopicYN="N">Infant, Newborn</DescriptorName>
</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="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="D011247" MajorTopicYN="N">Pregnancy</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D012621" MajorTopicYN="N">Seasons</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName>
</MeshHeading>
</MeshHeadingList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2018</Year>
<Month>08</Month>
<Day>15</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2018</Year>
<Month>11</Month>
<Day>27</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez"><Year>2018</Year>
<Month>12</Month>
<Day>21</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed"><Year>2018</Year>
<Month>12</Month>
<Day>21</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline"><Year>2019</Year>
<Month>2</Month>
<Day>7</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>epublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">30570077</ArticleId>
<ArticleId IdType="pii">S0036-46652019005000400</ArticleId>
<ArticleId IdType="doi">10.1590/S1678-9946201961004</ArticleId>
<ArticleId IdType="pmc">PMC6300789</ArticleId>
</ArticleIdList>
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</PubmedData>
</pubmed>
<affiliations><list><country><li>Brésil</li>
</country>
<region><li>État de São Paulo</li>
</region>
<settlement><li>São Paulo</li>
</settlement>
<orgName><li>Université de São Paulo</li>
</orgName>
</list>
<tree><country name="Brésil"><region name="État de São Paulo"><name sortKey="Gattas, Vera Lucia" sort="Gattas, Vera Lucia" uniqKey="Gattas V" first="Vera Lúcia" last="Gattás">Vera Lúcia Gattás</name>
</region>
<name sortKey="Braga, Patricia Emilia" sort="Braga, Patricia Emilia" uniqKey="Braga P" first="Patrícia Emília" last="Braga">Patrícia Emília Braga</name>
<name sortKey="Koike, Marcelo Eiji" sort="Koike, Marcelo Eiji" uniqKey="Koike M" first="Marcelo Eiji" last="Koike">Marcelo Eiji Koike</name>
<name sortKey="Lucchesi, Maria Beatriz Bastos" sort="Lucchesi, Maria Beatriz Bastos" uniqKey="Lucchesi M" first="Maria Beatriz Bastos" last="Lucchesi">Maria Beatriz Bastos Lucchesi</name>
<name sortKey="Oliveira, Mayra Martho Moura De" sort="Oliveira, Mayra Martho Moura De" uniqKey="Oliveira M" first="Mayra Martho Moura De" last="Oliveira">Mayra Martho Moura De Oliveira</name>
<name sortKey="Piorelli, Roberta De Oliveira" sort="Piorelli, Roberta De Oliveira" uniqKey="Piorelli R" first="Roberta De Oliveira" last="Piorelli">Roberta De Oliveira Piorelli</name>
<name sortKey="Precioso, Alexander Roberto" sort="Precioso, Alexander Roberto" uniqKey="Precioso A" first="Alexander Roberto" last="Precioso">Alexander Roberto Precioso</name>
<name sortKey="Precioso, Alexander Roberto" sort="Precioso, Alexander Roberto" uniqKey="Precioso A" first="Alexander Roberto" last="Precioso">Alexander Roberto Precioso</name>
<name sortKey="Queiroz, Vivian" sort="Queiroz, Vivian" uniqKey="Queiroz V" first="Vivian" last="Queiroz">Vivian Queiroz</name>
</country>
</tree>
</affiliations>
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Safety assessment of seasonal trivalent influenza vaccine produced by Instituto Butantan from 2013 to 2017.

Safety assessment of seasonal trivalent influenza vaccine produced by Instituto Butantan from 2013 to 2017.

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