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6至35月龄健康儿童四价流感亚单位疫苗的安全性和免疫原性:一项随机、盲法和阳性对照的III期临床试验。

The Safety and Immunogenicity of a Quadrivalent Influenza Subunit Vaccine in Healthy Children Aged 6-35 Months: A Randomized, Blinded and Positive-Controlled Phase III Clinical Trial.

作者信息

Huang Lili, Li Guangfu, Zhang Yuhui, Zhao Xue, Wang Kai, Jia Chunyu, Zhang Wei, Tan Jiebing, Chen Xiaofen, Li Qin, Jiang Hongyan, An Rui, Leng Wenna, Yang Yongli, An Youcai, Wang Yanxia, Zhang Yaodong

机构信息

Henan Provincial Centre for Disease Control and Prevention, Zhengzhou 450016, China.

Ab&B Bio-Tech Co., Ltd. JS, Taizhou 225300, China.

出版信息

Vaccines (Basel). 2025 Apr 26;13(5):467. doi: 10.3390/vaccines13050467.

Abstract

: Influenza is a serious contagious disease caused by influenza virus. It is particularly dangerous for children, potentially leading to severe and even fatal complications. The aim of this study was to evaluate the safety and immunogenicity of two candidate quadrivalent influenza subunit vaccines in children aged 6-35 months. : The subjects were randomly divided into three groups at a 1:1:1 ratio and received the corresponding vaccines: QIV-Sub-HD (Quadrivalent Influenza Subunit Vaccine, High Dose), QIV-Sub-LD (Quadrivalent Influenza Subunit Vaccine, Low Dose) and QIV-Split-LD (Quadrivalent Influenza Split-Virion Vaccine, Low Dose). Adverse events were recorded at 30 min, 0-7 days and 8-28 and 30 days after each dose of immunization. Serious adverse events (SAEs) were collected and reported within 6 months after the full vaccination. Blood samples were collected before the first dose and on 28 days, 3 months and 6 months after full vaccination for antibody detection to evaluate the immunogenicity and duration of immune responses. : The results showed that the relative and absolute criteria met the goals set by the clinical trial protocol, indicating that both vaccines are immunogenic. From the first dose to 30 days after full vaccination, the total incidence of adverse reactions in the QIV-Sub-HD, QIV-Sub-LD and QIV-Split-LD groups was 29.64%, 33.33% and 29.64%, respectively. The main symptoms were fever, cough, diarrhea and vomiting. No new safety concerns were identified. : The quadrivalent influenza subunit vaccines candidate, manufactured by Ab&B Bio-tech Co., Ltd. JS., are safe and immunogenic in children aged 6-35 months.

摘要

流感是一种由流感病毒引起的严重传染病。它对儿童尤其危险,可能导致严重甚至致命的并发症。本研究的目的是评估两种候选四价流感亚单位疫苗在6至35个月大儿童中的安全性和免疫原性。

受试者按1:1:1的比例随机分为三组,并接种相应疫苗:QIV-Sub-HD(四价流感亚单位疫苗,高剂量)、QIV-Sub-LD(四价流感亚单位疫苗,低剂量)和QIV-Split-LD(四价裂解流感病毒疫苗,低剂量)。在每次接种疫苗后30分钟、0至7天、8至28天和30天记录不良事件。收集并报告全程接种后6个月内的严重不良事件(SAE)。在首次接种前以及全程接种后28天、3个月和6个月采集血样进行抗体检测,以评估免疫原性和免疫反应持续时间。

结果表明,相对标准和绝对标准均符合临床试验方案设定的目标,表明两种疫苗均具有免疫原性。从首次接种到全程接种后30天,QIV-Sub-HD组、QIV-Sub-LD组和QIV-Split-LD组的不良反应总发生率分别为29.64%、33.33%和29.64%。主要症状为发热、咳嗽、腹泻和呕吐。未发现新的安全问题。

由Ab&B生物科技有限公司JS生产的候选四价流感亚单位疫苗在6至35个月大的儿童中是安全且具有免疫原性的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f07/12116156/cbda6eae2173/vaccines-13-00467-g001.jpg

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