[Translation] A multicenter, randomized, double-blind, parallel-controlled Phase IV clinical trial to evaluate the protective efficacy, safety, and immunogenicity of influenza virus split vaccine (15μg/subtype/0.5ml/dose) in people aged 9-59 years and ≥60 years
主要目的:
评价流感病毒裂解疫苗(15μg/亚型/0.5ml/剂)(以下简称“流感疫苗”)按1剂接种于9-59周岁和≥60周岁人群后14天,在1个流感流行季内,预防经实验室确诊(核酸检测RT-qPCR方法)流感病例的保护效力。 次要目的:
(1 )评价流感疫苗按1剂接种于9-59周岁和≥60周岁人群后14天,在1个流感流行季内,预防经实验室确诊(核酸检测RT-qPCR方法)重症流感病例的保护效力。
(2)评价流感疫苗按1剂接种于9-59周岁和≥60周岁人群后14天,在1个流感流行季内,预防经实验室确诊(病毒培养检测法)与疫苗毒株相匹配流感病例的保护效力。
(3)评价流感疫苗按1剂接种于9-59周岁和≥60周岁人群的安全性。 探索性目的:
(1)评价流感疫苗按1剂接种于9-59周岁和≥60周岁人群后第30天的免疫原性。探索不同人群、不同亚型的保护效力与免疫学指标相关性。
(2)评价流感疫苗按1剂接种于9-59周岁和≥60周岁人群后180天的免疫持久性。
[Translation] Primary objectives:
To evaluate the protective efficacy of influenza virus split vaccine (15μg/subtype/0.5ml/dose) (hereinafter referred to as "influenza vaccine") in preventing laboratory-confirmed influenza cases (nucleic acid detection RT-qPCR method) in people aged 9-59 years and ≥60 years 14 days after a single dose during an influenza epidemic season. Secondary objectives:
(1) To evaluate the protective efficacy of influenza vaccine in preventing laboratory-confirmed severe influenza cases (nucleic acid detection RT-qPCR method) in people aged 9-59 years and ≥60 years 14 days after a single dose during an influenza epidemic season.
(2) To evaluate the protective efficacy of influenza vaccine in preventing laboratory-confirmed influenza cases (virus culture detection method) with a matching vaccine strain in people aged 9-59 years and ≥60 years 14 days after a single dose during an influenza epidemic season.
(3) To evaluate the safety of influenza vaccine in people aged 9-59 years and ≥60 years. Exploratory objectives:
(1) To evaluate the immunogenicity of influenza vaccine at 30 days after a single dose in people aged 9-59 years and ≥60 years. To explore the correlation between the protective efficacy and immunological indicators of different populations and subtypes.
(2) To evaluate the immune persistence of influenza vaccine at 180 days after a single dose in people aged 9-59 years and ≥60 years.