Post-Marketing Active Surveillance of Adverse Events Following Quadrivalent Subunit Influenza Vaccine in Healthy Participants Aged ≥ 3 Years in China.

IF 5.3 3区医学 Q1 INFECTIOUS DISEASES

Infectious Diseases and Therapy Pub Date : 2026-05-08 DOI:10.1007/s40121-026-01354-z

Mingwei Wei, Yu Pan, Kangning Wang, Ming Li, Shaowen Tang, Qianqian Huang, Hongying Chen, Zengqiang Kou, Na Xie, Xiang Guo, Jing An, Jikai Zhang, A Kezhong, Yanjun Chen, Youcai An, Liuyang Kang, Hang Tao, Hongxing Pan

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引用次数: 0

Abstract

Introduction: The observational phase IV study through an active surveillance system aimed to assess the safety of the subunit influenza vaccine in healthy individuals aged ≥ 3 years and explore the feasibility of using an active adverse event (AE) surveillance system based on a WeChat Mini Program incorporating electronic diary cards (e-diary cards) in China.

Methods: Between October 30, 2023, and April 28, 2025, a multi-center, open-label, single-arm prospective active surveillance study was conducted. Healthy individuals aged 3 years and above who voluntarily and at their own expense came to the outpatient department to receive the target vaccine (Ab&B Biotech Co., Ltd., Jiangsu, China) were recruited as research participants. The WeChat Mini Program was employed to record baseline information and the occurrence of AEs and adverse drug reactions (ADRs) within 28 days after vaccination. A post hoc subgroup analysis was conducted to assess the safety characteristics of participants in different age groups.

Results: Among the 42,881 participants, 495 (11.54‰) reported a total of 682 AEs. No vaccine-related serious adverse events (SAEs) were reported. A total of 293 participants (6.83‰) reported 374 ADRs. Among these, 29 participants (0.68‰) reported 34 unsolicited ADRs, including pharyngalgia (n = 10, 0.23‰) and rhinorrhea (n = 4, 0.09‰) among others. The incidence rates (IR) of AEs across 3-8, 9-17, 18-64, ≥ 65 years groups, from youngest to oldest, were 16.29‰ (n = 269), 10.63‰ (n = 58), 10.53‰ (n = 145), and 3.21‰ (n = 23). A statistically significant difference in AE incidence was observed among the age groups (P < 0.001).

Conclusions: The vaccine demonstrated a favorable safety profile in healthy individuals aged 3 years and above. Moreover, the active surveillance method with the Mini Program was helpful in detecting very rare ADRs.

Trial registration: NCT073326896. Retrospectively registered.

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中国≥3岁健康受试者接种四价亚单位流感疫苗后不良事件的上市后主动监测

本观察性IV期研究通过主动监测系统，旨在评估亚单位流感疫苗在≥3岁健康个体中的安全性，并探索在中国使用基于微信小程序结合电子日记卡（e-diary cards）的主动不良事件（AE）监测系统的可行性。方法：在2023年10月30日至2025年4月28日期间，进行了一项多中心、开放标签、单臂前瞻性主动监测研究。招募自愿自费到门诊接种目标疫苗的3岁及以上健康个体作为研究参与者（Ab&B Biotech Co., Ltd, Jiangsu, China）。采用微信小程序记录接种后28天内的基线信息及不良反应（ae）和药物不良反应（adr）发生情况。进行了一项事后亚组分析，以评估不同年龄组参与者的安全性特征。结果：在42,881名参与者中，495名（11.54‰）报告了总共682例ae。无疫苗相关严重不良事件（SAEs）报告。共有293名参与者（6.83‰）报告了374例adr。其中，29名参与者（0.68‰）报告了34个非主动adr，包括咽痛（n = 10, 0.23‰）和鼻漏（n = 4, 0.09‰）等。3 ~ 8岁、9 ~ 17岁、18 ~ 64岁、≥65岁年龄组ae的发生率依次为16.29‰（n = 269）、10.63‰（n = 58）、10.53‰（n = 145）、3.21‰（n = 23）。不同年龄组的AE发病率差异有统计学意义(P)。结论：该疫苗在3岁及以上的健康人群中具有良好的安全性。此外，小程序的主动监测方法有助于发现非常罕见的adr。试验注册：NCT073326896。回顾注册。

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

Infectious Diseases and Therapy Medicine-Microbiology (medical)

CiteScore

8.60

自引率

1.90%

发文量

136

审稿时长

6 weeks

期刊介绍： Infectious Diseases and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of infectious disease therapies and interventions, including vaccines and devices. Studies relating to diagnostic products and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, bacterial and fungal infections, viral infections (including HIV/AIDS and hepatitis), parasitological diseases, tuberculosis and other mycobacterial diseases, vaccinations and other interventions, and drug-resistance, chronic infections, epidemiology and tropical, emergent, pediatric, dermal and sexually-transmitted diseases.