Clinical development and evaluation of human respiratory syncytial virus vaccines
CHEN Yan
WANG Hai-xue
Abstract：Human respiratory syncytial virus (RSV) is a common respiratory virus that is widely prevalent worldwide. RSV can infect people of all ages,but it is mainly concentrated in high-risk groups such as children,elderly,and immunocompromised individuals,bringing a heavy disease burden to children under 5 years old and the elderly population. Vaccines are one of the important means to prevent RSV infection,transmission,and progression of illness. The WHO has listed RSV vaccines as one of the world's top priority vaccines to research and develop. At present,three RSV vaccines have been approved for marketing abroad,and several imported RSV vaccines have obtained clinical trial licenses in China,but have not yet been approved for marketing. This article summarizes the key points of confirmatory clinical trials of RSV vaccines that have already been marketed,as well as the technical guidelines for clinical development of RSV vaccines abroad. Based on relevant domestic work foundations and technical literatures,the feasibility and reference experiences of such vaccines in clinical development in China are analyzed and discussed,providing references for sponsors and clinical researchers.
Keywords：human respiratory syncytial virusvaccinesclinical developmentguidelines
Publication Date：2025-01-14
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：9( 43-51 )