ArticleVaccines2021
Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study.
Article in Vaccines, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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Who cites it
19 citing papers in PubMed, 30 citations in OpenAlex.
- Adverse events following measles, mumps, rubella and varicella virus vaccine live (PROQUADVirology journal · 2025Article
- Active offer of Tdap vaccination in a cohort of healthcare workers of Maternal and Neonatal Department: Data from a large hospital in Southern Italy.Vaccine: X · 2024Article
- Influenza vaccine coverage in 6months-64 years-old patients affected by chronic diseases: A retrospective cohort study in Italy.Human vaccines & immunotherapeutics · 2023Article
- Determinants of compliance to influenza and COVID-19 vaccination in a cohort of solid organ transplant patients in Puglia, Southern Italy (2017-2022).Human vaccines & immunotherapeutics · 2023Article
- The Effect of Sex on the Incidence, Latency, Duration and Perceived Burden of Adverse Events Following Seasonal Influenza Vaccination in the Netherlands.Drug safety · 2023Article
- Three seasons of enhanced safety surveillance of a cell culture-based quadrivalent influenza vaccine.Human vaccines & immunotherapeutics · 2023Article
- Self-reported side effects following COVID-19 vaccination in athletes: A retrospective study.Human vaccines & immunotherapeutics · 2023Article
- Review
- Immunogenicity and Safety of Adjuvanted Recombinant Zoster Vaccine in Rheumatoid Arthritis Patients on Anti-Cellular Biologic Agents or JAK Inhibitors: A Prospective Observational Study.International journal of molecular sciences · 2023Observational
- Past and Future Influenza Vaccine Uptake Motivation: A Cross-Sectional Analysis among Italian Health Sciences Students.Vaccines · 2023Article
- COVID-19 vaccine acceptance and associated factors among health workers in West Guji zone, Southern Ethiopia: Cross-sectional study.Frontiers in public health · 2023Article
- Allergic adverse events following immunization: Data from post-marketing surveillance in Apulia region (South of Italy).Frontiers in immunology · 2023Observational
- Three doses of a recombinant conjugated SARS-CoV-2 vaccine early after allogeneic hematopoietic stem cell transplantation: predicting indicators of a high serologic response-a prospective, single-arm study.Frontiers in immunology · 2023Article
- Acceptance of recommended vaccinations during pregnancy: a cross-sectional study in Southern Italy.Frontiers in public health · 2023Article
- Measuring the importance of influencing factor for COVID-19 vaccination intention in China.Frontiers in public health · 2023Article
- Safety profile of MenB-FHBp vaccine among adolescents: data from surveillance of Adverse Events Following Immunization in Puglia (Italy), 2018-2020.Human vaccines & immunotherapeutics · 2022Observational
- [Health Technology Assessment: a value-based tool for the evaluation of healthcare technologies. Reassessment of the cell-culture-derived quadrivalent influenza vaccine: Flucelvax TetraJournal of preventive medicine and hygiene · 2022Article
- Real-Life Safety Profile of the 9-Valent HPV Vaccine Based on Data from the Puglia Region of Southern Italy.Vaccines · 2022Article
- Article
Corrections and comments
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Authors and funding
11 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Since the influenza season 2018/19, the Italian Ministry of Health recommended a dose of cell-based quadrivalent vaccine (Flucelvax Tetra) for HCWs (healthcare workers), because this vaccine seemed more efficacious in the prevention of AH3N2 virus. Due to the lack of pre-registration data, the safety profile of this new vaccine must be investigated in post-marketing surveillance. The aim of our study is to evaluate, through a post-marketing active surveillance program developed during the 2019/20 influenza season, any Adverse Events Following Immunization (AEFIs) that happened in the 7 days after immunization with Flucelvax Tetra. The study was carried out in a sample of HCWs of Policlinico General University-Hospital (Apulia, South Italy). AEFIs were classified as 'serious' or 'not serious' according to the WHO (World Health Organization) guidelines; the WHO causality assessment algorithm was applied to classify serious AEFIs. A total of 741 HCWs were enrolled, and 430 AEFIs (reporting rate: 58.0 (95%CI: 54.4-61.6) × 100 enrolled) were recorded. Of these, 429 of 430 (99.8%; reporting rate: 57.8 (95%CI: 54.2-61.5) × 100 enrolled) were classified as not serious and one (0.2%; reporting rate: 0.13 (0.03-0.75) × 100 enrolled) was classified as serious. Local reactions were the adverse reaction reported most frequently (88%); regarding the serious AEFI, causality assessment excluded the causal link with the administration of the vaccine. All the AEFIs resolved without sequelae. Flucelvax Tetra showed a profile of high safety. Due to their characteristics of greater sensitivity than passive surveillance, active surveillance programs can be useful in defining the safety profiles of a given vaccine/drug in certain population subgroups.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.