Enhanced Safety Surveillance of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season.

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-06-29 DOI:10.1007/s40264-024-01456-y
Ignacio Salamanca de la Cueva, Jennifer E Gerber, Andrew Hastie, Carlos Brotons, Falko Panzer, Jean-Yves Pirçon, Paul Talsma, Tamara Eckermann, Vanja Nikic, Xavier Martinez Gomez, Hannah Alsdurf
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引用次数: 0

Abstract

Background: Seasonal influenza is prevented through annual vaccination, especially in children and older adults. These vaccines are annually updated based on World Health Organization recommendations and require continuous safety monitoring.

Objective: We assessed the frequency and severity of adverse events within 7 days of administering GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4) in Belgium, Germany, and Spain during the 2022/2023 influenza season.

Methods: In this enhanced safety surveillance study, adults who received GSK's IIV4 and parents/guardians/legally acceptable representatives of vaccinated children (aged 6 months-17 years) were invited to complete adverse drug reaction cards reporting adverse events within 7 days post-vaccination.

Results: In total, 1332 participants (53.6% female) received at least one dose of GSK's IIV4, including 43 children who received two doses. Overall, 97.8% of adverse drug reaction cards were completed and returned in the study. All participants in Belgium were adults, while 54.7% and 7.4% in Spain and Germany, respectively, were pediatric participants aged 6 months-17 years. After Dose 1, across all age groups, 49.8% of participants reported at least one adverse event. The most common adverse events (cumulative frequency >5%) following Dose 1 were injection-site pain (37.6%), fatigue (15.0%), headache (13.2%), injection-site swelling (9.3%), myalgia (7.6%), and injection-site erythema (7.4%). Across all countries, adverse events were most common in adults aged 18-65 years (59.7%), followed by those aged 3-17 years (47.0%), >65 years (35.7%), and 6-35 months (23.5%). After Dose 2, 18.6% of participants reported at least one adverse event, with general disorders and administration site conditions again being the most frequent.

Conclusions: Across all age and risk groups for serious disease, no serious adverse events related to GSK's IIV4 were reported within 7 days post-vaccination. This study supports and confirms the acceptable safety profile of GSK's IIV4 across all recommended age groups.

Clinical trial registration: ClinicalTrials.gov number: not applicable.

Abstract Image

2022/2023 年流感季节期间在比利时、德国和西班牙加强对葛兰素史克四价灭活季节性流感疫苗的安全性监测。
背景:季节性流感可通过每年接种疫苗来预防,尤其是儿童和老年人。这些疫苗每年都会根据世界卫生组织的建议进行更新,需要持续进行安全性监测:我们评估了 2022/2023 年流感季节期间比利时、德国和西班牙接种葛兰素史克四价季节性流感灭活疫苗(IIV4)后 7 天内不良事件的发生频率和严重程度:在这项强化安全性监测研究中,我们邀请接种了葛兰素史克四价灭活疫苗的成年人和接种儿童(6 个月至 17 岁)的父母/监护人/合法代表填写药物不良反应卡,报告接种后 7 天内发生的不良事件:共有 1332 名参与者(53.6% 为女性)至少接种了一剂葛兰素史克的 IIV4 疫苗,其中 43 名儿童接种了两剂。总体而言,97.8%的药物不良反应卡在研究中完成并交回。比利时的所有参与者均为成年人,而西班牙和德国分别有 54.7% 和 7.4% 的参与者为 6 个月至 17 岁的儿童。第 1 剂后,在所有年龄组中,49.8% 的参与者报告了至少一种不良反应。第一剂后最常见的不良反应(累计频率>5%)为注射部位疼痛(37.6%)、疲劳(15.0%)、头痛(13.2%)、注射部位肿胀(9.3%)、肌痛(7.6%)和注射部位红斑(7.4%)。在所有国家中,不良事件最常见于 18-65 岁的成年人(59.7%),其次是 3-17 岁(47.0%)、65 岁以上(35.7%)和 6-35 个月(23.5%)的人群。在剂量 2 之后,18.6% 的参与者报告了至少一种不良事件,其中最常见的仍然是一般疾病和用药部位疾病:结论:在所有年龄组和严重疾病风险组中,接种后 7 天内未出现与葛兰素史克公司 IIV4 疫苗相关的严重不良事件。这项研究支持并证实了葛兰素史克公司的IIV4在所有推荐年龄组中均具有可接受的安全性:临床试验注册:ClinicalTrials.gov 编号:不适用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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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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