一项为期 8 年的前瞻性、观察性、多中心上市后安全性监测研究(2014-2022 年),在韩国针对 6 个月及以上年龄的受试者引入葛兰素史克四价季节性流感灭活疫苗(Fluarix Tetra)后进行。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-04-01 Epub Date: 2024-03-14 DOI:10.1007/s40264-024-01395-8
Gaël Dos Santos, Raghavendra Devadiga, Chun Soo Kim, Joon Bang
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引用次数: 0

摘要

导言:季节性流感给公共卫生带来了巨大负担。本研究旨在评估四价季节性流感灭活疫苗(IIV4,比利时葛兰素史克公司生产的 Fluarix Tetra)在韩国年龄≥6 个月受试者中的安全性:这项前瞻性、观察性、非比较性、多中心上市后监测研究在韩国对年龄≥3岁的受试者进行了为期6年(2014-2020年)的研究,并将研究扩展至年龄为6-35个月的受试者,为期4年(2018-2022年)。受试者根据当地处方信息在常规临床实践中接受 IIV4。接种后21天内记录不良事件(AEs):年龄≥3岁组包括701名受试者(平均31.97岁,年龄范围3-86岁,46.36%为男性),年龄6-35个月组包括687名受试者(平均16.31个月,47.02%为男性)。在年龄≥3岁的组别中,98名受试者(13.98%)报告了140例AE,其中34名受试者(4.85%)的42例为疫苗(ARV)不良反应。大多数 ARV 都在预料之中,主要是接种部位反应。有 7 例轻微的意外 ARV。在 6-35 个月大的群体中,149/687 名受试者(21.69%)报告了 248 例不良反应。25/687名受试者(3.64%,29起事件)报告了抗逆转录病毒药物不良反应,其中1起被视为意外。总计发生了 5 起严重的 AEs,其中没有一起被认为与此有关:结论:在对韩国年龄≥6个月的受试者进行的IIV4监测研究中,未发现任何安全性问题。这项研究结果表明,IIV4 用于所有年龄组的疫苗接种都是安全和耐受性良好的。
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An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014-2022) Following the Introduction of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older.

Introduction: Seasonal influenza is associated with substantial public health burden. The objective of this study was to assess the safety of inactivated quadrivalent seasonal influenza vaccine (IIV4, Fluarix Tetra, GSK, Belgium) in subjects aged ≥ 6 months in Korea.

Methods: This prospective, observational, non-comparative, multi-centre post-marketing surveillance study was conducted in Korea in subjects aged ≥ 3 years for 6 years (2014-2020) and extended to subjects aged 6-35 months for 4 years (2018-2022). Subjects received IIV4 in routine clinical practice according to local prescribing information. Adverse events (AEs) were recorded over 21 days post-vaccination.

Results: The group aged ≥ 3 years included 701 subjects (mean 31.97 years, range 3-86 years, 46.36% male), and the group aged 6-35 months included 687 subjects (mean 16.31 months, 47.02% male). In the group aged ≥ 3 years, 98 subjects (13.98%) reported 140 AEs, of which 42 events in 34 subjects (4.85%) were adverse reactions to vaccine (ARVs). Most of the ARVs were expected, mainly administration site reactions. There were seven mild unexpected ARVs. In the group aged 6-35 months, 248 AEs were reported in 149/687 subjects (21.69%). ARVs were reported in 25/687 subjects (3.64%, 29 events); one was considered unexpected. There were five serious AEs overall, none of which were considered related.

Conclusion: No safety concerns were found during this surveillance study of IIV4 in subjects aged ≥ 6 months in Korea. The findings of this study suggest IIV4 is safe and well tolerated for use in all age groups with a vaccine indication.

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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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