| アブストラクト | OBJECTIVE: The vaccines for measles, mumps, rubella and varicella (MMR and V) have been mandatory in Italy since 2017. Two different vaccination strategies are suggested for the first dose: trivalent MMR and a separate V vaccine or the tetravalent MMRV vaccine. Our aim is to compare the safety profile of MMRV and MMR-V vaccines through the passive adverse event reporting system in the Veneto region and to perform a case-by-case review of a few conditions of interest (febrile and afebrile seizures, ataxia, encephalitis, Guillain-Barre Syndrome, thrombocytopenia, neutropenia and Henoch-Schonlein Purpura). Age and sex differences were also explored. METHODS: We identified all reports following MMRV or MMR-V vaccination in the Veneto Region and received into the National Pharmacovigilance Network between 2007 and April 30, 2022. RESULTS: 9,510 reports were retrieved, of which 5,662 (59.5 %) were related to MMRV and 3,848 (40.5 %) to MMR-V. No safety signals were detected supporting the evidence that MMRV and MMR-V vaccinations have a good safety profile. The reporting rate (RR) for serious events between 2007 and 2022 resulted in 13.67 per 10,000 administered doses for MMRV and 10.90 for MMR-V. CONCLUSION: Passive surveillance data show a significantly higher rate of serious events for males 0-2 years old, both overall and stratified per vaccination strategy. Further studies are needed to confirm this observation. The analyses suggest that retrieved differences do not have a significant impact on the overall safety of both formulations. |
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| ジャーナル名 | Preventive medicine reports |
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| Pubmed追加日 | 2024/4/12 |
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| 投稿者 | Soriolo, Nicola; Benoni, Roberto; Dalla Valle, Diana; Zunino, Francesco; Olivieri, Adele; Campagna, Irene; Tardivo, Stefano; Augusta Gonella, Laura; Russo, Francesca; Tonon, Michele; Da Re, Filippo; Moretti, Ugo; Zanoni, Giovanna; Moretti, Francesca |
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| 組織名 | University of Verona, Diagnostics and Public Health Department, Section of;Hygiene and Preventive Medicine, Verona, Italy.;Pharmacology, Verona, Italy.;Directorate for Prevention, Food Safety, Veterinary - Public Health Veneto;Region, Italy.;University Hospital of Verona, Pathology and Diagnostics Department, Immunology;Unit, Verona, Italy.;University of Verona, Neurosciences, Biomedicine and Movement Sciences;Department, Verona, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38606113/ |
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