Active pharmacovigilance of the seasonal trivalent influenza vaccine produced by Instituto Butantan: a prospective cohort study of five target groups

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dc.contributorCentro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributorCentro de Segurança Clínica e Gestão de Riscospt_BR
dc.contributor.authorVanni, Taziopt_BR
dc.contributor.authorThomé, Beatrizpt_BR
dc.contributor.authorOliveira, Mayra Martho Moura dept_BR
dc.contributor.authorGattás, Vera Lúciapt_BR
dc.contributor.authorSalomão, Maria da Graçapt_BR
dc.contributor.authorKoike, Marcelo Eijipt_BR
dc.contributor.authorLucchesi, Maria Beatriz Bastospt_BR
dc.contributor.authorBraga, Patrícia Emíliapt_BR
dc.contributor.authorPiorelli, Roberta de Oliveirapt_BR
dc.contributor.authorViscondi, Juliana Yukari Koidarapt_BR
dc.contributor.authorMondini, Gabriellapt_BR
dc.contributor.authorSilva, Anderson dapt_BR
dc.contributor.authorEspinola, Heloisa Maxímopt_BR
dc.contributor.authorSantos, Joane do Pradopt_BR
dc.contributor.authorWeckx, Lily Yinpt_BR
dc.contributor.authorMenang, Olgapt_BR
dc.contributor.authorSoquet, Murielpt_BR
dc.contributor.authorPrecioso, Alexander Robertopt_BR
dc.contributor.authorRocha, Samanta Hosokawa Dias de Nóvoapt_BR
dc.date.accessioned2021-02-16T17:33:06Z-
dc.date.available2021-02-16T17:33:06Z-
dc.date.issued2021pt_BR
dc.identifier.citationVanni T, Thomé B, Oliveira MMM, Gattas VL, Salomão MG, Koike ME, et al. Active pharmacovigilance of the seasonal trivalent influenza vaccine produced by Instituto Butantan: a prospective cohort study of five target groups. PloS One. 2021 Fev;16(2)e0246540. doi:10.1371/journal.pone.0246540.pt_BR
dc.identifier.urihttps://repositorio.butantan.gov.br/handle/butantan/3536-
dc.description.abstractActive pharmacovigilance studies are pivotal to better characterize vaccine safety. Methods: These are multicenter prospective cohort studies to evaluate the safety of the 2017 and 2018 seasonal trivalent influenza vaccines (TIVs) manufactured by Instituto Butantan, by means of active pharmacovigilance practices. Elderly, children, healthcare workers, pregnant women, and women in the puerperium period were invited to participate in the study during the 2017 and 2018 Brazilian national seasonal influenza vaccination campaigns. Following immunization, participants were observed for 30 minutes and they received a participant card to register adverse events information. All safety information registered were checked at a clinical site visit 14 days after immunization and by a telephone contact 42 days after immunization for unsolicited Adverse Events (AE) and Guillain-Barré Syndrome (GBS). Results: A total of 942 volunteers participated in the two studies: 305 elderly, 109 children, 108 pregnant women, 32 women in the postpartum period, and 388 health workers. Overall, the median number of AR per participant ranged from 1 to 4. The lowest median number of AR per participant was observed among healthcare workers (1 AR per participant) and the highest among pregnant women (4 AR per participant). Overall, local pain (46.6%) was the most frequent solicited local AR. The most frequent systemic ARs were: headache (22.5%) followed by fatigue (16.0%), and malaise (11.0%). The majority of solicited ARs (96%) were mild, Grades 1 or 2), only 3% were Grade 3, and 1% was Grade 4. No serious AEs, including Guillain-Barré Syndrome, were reported up to 42 days postvaccination. Conclusion: The results from the two studies confirmed that the 2017 and 2018 seasonal trivalent influenza vaccines produced by Instituto Butantan were safe and that active pharmacovigilance studies should be considered, when it is feasible, as an important initiative to monitor vaccine safety in the post-marketing period.pt_BR
dc.description.sponsorshipInstituto Butantanpt_BR
dc.format.extente0246540pt_BR
dc.language.isoEnglishpt_BR
dc.relation.ispartofPloS Onept_BR
dc.rightsOpen Accesspt_BR
dc.titleActive pharmacovigilance of the seasonal trivalent influenza vaccine produced by Instituto Butantan: a prospective cohort study of five target groupspt_BR
dc.typeArticlept_BR
dc.identifier.doi10.1371/journal.pone.0246540pt_BR
dc.identifier.urlhttps://doi.org/10.1371/journal.pone.0246540pt_BR
dc.contributor.externalUniversidade de São Paulo (USP)pt_BR
dc.contributor.externalUniversity of Oxfordpt_BR
dc.contributor.externalUniversidade Federal de Roraima (UFRR)pt_BR
dc.contributor.externalUniversidade Federal de São Paulo (UNIFESP)pt_BR
dc.contributor.externalCenter for Vaccine Innovation and Access, PATH, Genevapt_BR
dc.identifier.citationvolume16pt_BR
dc.identifier.citationissue2pt_BR
dc.relation.ispartofabbreviatedPloS Onept_BR
dc.identifier.citationabntv. 16, n. 2, e0246540, fev. 2021pt_BR
dc.identifier.citationvancouver2021 Fev;16(2)e0246540pt_BR
dc.contributor.butantanVanni, Tazio|:Pesquisador|:Centro de Segurança Clínica e Gestão de Riscos:Centro de Ensaios Clínicos e Farmacovigilância|:PrimeiroAutor:Autor de correspondênciapt_BR
dc.contributor.butantanOliveira, Mayra Martho Moura de|:Técnico|:Centro de Segurança Clínica e Gestão de Riscos:Centro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributor.butantanGattás, Vera Lúcia|:Pesquisador|:Centro de Segurança Clínica e Gestão de Riscos:Centro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributor.butantanSalomão, Maria da Graça|:Pesquisador|:Centro de Segurança Clínica e Gestão de Riscos:Centro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributor.butantanKoike, Marcelo Eiji|:Técnico|:Centro de Segurança Clínica e Gestão de Riscos:Centro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributor.butantanLucchesi, Maria Beatriz Bastos|:Pesquisador|:Centro de Segurança Clínica e Gestão de Riscos:Centro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributor.butantanBraga, Patrícia Emília|:Pesquisador|:Centro de Segurança Clínica e Gestão de Riscos:Centro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributor.butantanPiorelli, Roberta de Oliveira|:Pesquisador|:Centro de Segurança Clínica e Gestão de Riscos:HBV - Hospital Vital Brazilpt_BR
dc.contributor.butantanViscondi, Juliana Yukari Koidara|:Técnico|:Centro de Segurança Clínica e Gestão de Riscospt_BR
dc.contributor.butantanSilva, Anderson da|:Técnico|:Centro de Segurança Clínica e Gestão de Riscos:Centro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributor.butantanEspinola, Heloisa Maxímo|:Técnico|:Centro de Segurança Clínica e Gestão de Riscos:Centro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributor.butantanSantos, Joane do Prado|:Técnico|:Centro de Segurança Clínica e Gestão de RiscosCentro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributor.butantanPrecioso, Alexander Roberto|:Pesquisador|:Centro de Segurança Clínica e Gestão de Riscos:Centro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.sponsorship.butantanInstituto Butantan¦¦pt_BR
dc.identifier.bvsccBR78.1pt_BR
dc.identifier.bvsdbIBProdpt_BR
dc.description.dbindexedYespt_BR
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