ArticleBMC public health2021
Enhanced passive safety surveillance of the quadrivalent inactivated split-virion influenza vaccine (IIV4) in Finland during the 2019/20 influenza season.
Article in BMC public health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed, 15 citations in OpenAlex.
- Challenges and future perspectives of enhanced passive safety surveillance of influenza vaccines in Europe.Therapeutic advances in drug safety · 2026Review
- Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the 2022/23 influenza season.Human vaccines & immunotherapeutics · 2024Article
- Three seasons of enhanced safety surveillance of a cell culture-based quadrivalent influenza vaccine.Human vaccines & immunotherapeutics · 2023Article
- Post-Marketing Safety Surveillance of Quadrivalent Influenza Vaccine (VaxigripTetra) in Children Aged 6 to 35 Months in South Korea.Infectious diseases and therapy · 2023Article
- Allergic adverse events following immunization: Data from post-marketing surveillance in Apulia region (South of Italy).Frontiers in immunology · 2023Observational
- [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
- Post-marketing Surveillance of a Quadrivalent Influenza Vaccine (Vaxigrip Tetra) in South Korea.Infectious diseases and therapy · 2022Article
- Enhanced passive safety surveillance of a quadrivalent inactivated split virion influenza vaccine in Finland during the influenza season 2020/21.BMC public health · 2022Article
- Safety of Using Traditional Chinese Medicine Injections in Primary Medical Institutions: Based on the Spontaneous Reporting System 2016-2020 in Henan Province, China.Frontiers in pharmacology · 2022Article
- The severity of adverse drug reactions and their influencing factors based on the ADR monitoring center of Henan Province.Scientific reports · 2021Article
- [Health Technology Assessment (HTA) of the introduction of influenza vaccination for Italian children with Fluenz TetraJournal of preventive medicine and hygiene · 2021Article
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsThe Enhanced Passive Safety Surveillance is a requirement of the European Medicines Agency (EMA) for seasonal influenza vaccines, aiming to rapidly detect any significant change in frequency or severity of expected reactogenicity or allergic events prior to widespread use of a vaccine in any particular year. The aim of this surveillance was to assess the quadrivalent inactivated split-virion influenza vaccine (IIV4) during routine immunization in Finland, as per the national immunization program for 2019/20. The primary objective was to investigate the suspected adverse drug reactions (ADR) occurring within 7 days following vaccination.
methodsPassive surveillance of individuals vaccinated with IIV4 was conducted within the first 4 to 6 weeks of the influenza season in Finland. Potential ADRs were reported via phone or posted adverse event forms. The vaccinee reporting rate and ADR reporting rate were calculated and compared with the known or expected safety data in order to identify any change which was clinically significant.
resultsData were collected from 939 individuals, with 56 reports received for 163 suspected ADRs. Of these, 38 individuals reported 117 suspected ADRs within 7 days following vaccination, corresponding to an ADR reporting rate of 12.46% (95% CI: 10.41, 14.74%); vaccination-site pain, vaccination-site reaction, and pyrexia were the most frequently reported ADRs. The 18-to-65 years of age category had an ADR reporting rate of 12.56%, the over-65 years of age category had an ADR reporting rate of 16.22%, and no ADRs were reported for individuals aged 6 months to 18 years. No serious suspected ADRs were reported at any time post-vaccination, and the ADR rates were comparable to those reported for IIV4 in the 2018/19 seasonal assessment. The frequency of suspected ADRs was generally aligned with those reported in the Summary of Product Characteristics (SmPC), with the exception of asthenia, somnolence, and erythema, which were slightly higher. No reporting pattern by type, frequency, or severity was identified for the suspected ADRs.
conclusionsNo clinically significant changes in what is known or expected for IIV4 was reported for the 2019/20 season, which supports the overall safety profile.
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