Ai Lizhe, Gao Zhao, Lv Huakun, Zhang Jikai, Xu Na, Zhao Hui, Lu Qiang, Zhu Hongcai, Shi Nianmin, Wei Wei, Liu Dawei, Yu Qiong
Department of Epidemiology and Biostatistics, School of Public Health, Jilin University, Changchun 130021, China.
Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China.
Vaccine. 2025 Feb 6;46:126653. doi: 10.1016/j.vaccine.2024.126653. Epub 2024 Dec 26.
(1) Background: The administration of a live attenuated influenza vaccine (LAIV) has emerged as a viable option for preventing pediatric infections. The LAIV vaccine is available in China based on efficacy results. However, LAIV immunogenicity in children aged 3-17 years old in China has not yet to be studied and reported broadly. (2) Methods: This is a substudy investigating the immunogenicity and safety of the LAIV under a Phase 3, multicentre, randomized, double-blind, placebo-controlled trial. A total of 3000 participants were enrolled in a randomized, double-blind, placebo-controlled trial, split in half between vaccine and placebo, was conducted to evaluate a single LAIV dose in this age group. Hemagglutination inhibition (HI) antibody titers and incidence of adverse events were used to evaluate immunogenicity and safety, respectively. (3) Results: Although there was no significant difference in frequencies of all solicited or unsolicited AEs, nasal congestion, headache, and muscle pain were statistically significantly more frequent in vaccine recipients as compared to placebo Seroconversions and geometric mean fold increases in HI antibody titers against all strains were significantly higher in the vaccine group than in the placebo group. (4) Conclusions: The LAIV is safe and immunogenic in Chinese children and adolescents.
(1) 背景：接种减毒活流感疫苗（LAIV）已成为预防儿童感染的一种可行选择。基于有效性结果，LAIV疫苗在中国已可获得。然而，中国3至17岁儿童的LAIV免疫原性尚未得到广泛研究和报道。(2) 方法：这是一项在3期多中心随机双盲安慰剂对照试验中调查LAIV免疫原性和安全性的子研究。共有3000名参与者被纳入一项随机双盲安慰剂对照试验，该试验分为疫苗组和安慰剂组，每组各半，旨在评估该年龄组单剂LAIV的效果。血凝抑制（HI）抗体滴度和不良事件发生率分别用于评估免疫原性和安全性。(3) 结果：尽管所有预期或非预期不良事件的发生频率没有显著差异，但与安慰剂相比，疫苗接种者出现鼻塞、头痛和肌肉疼痛的频率在统计学上显著更高。疫苗组针对所有毒株的血清转化和HI抗体滴度的几何平均倍数增长均显著高于安慰剂组。(4) 结论：LAIV在中国儿童和青少年中是安全且具有免疫原性的。
