【摘要】 疫苗是一类适用对象为健康人群的特殊药物，临床试验是疫苗上市应用前的关键环节。本文结合疫苗临床试验实践和监管机构要求，基于我国疫苗临床试验现状，参考相关法律法规和技术指导原则，探讨了不同设计情形下疫苗临床试验实施中的关键控制点，包括疫苗临床试验实施的组织管理、疫苗安全性评估、免疫原性终点、保护效力终点的确定和病例收集、试验的盲态维持、知情同意书签署、受试者随访的依从性等，以期为疫苗临床试验的组织管理和实施提供参考。更多还原

【Abstract】 Vaccines are special drugs intended for healthy populations, and vaccine clinical trials are a crucial step before market approval. This article introduces the practices of vaccine clinical trials and the requirements of domestic and foreign regulatory agencies. Based on the current status of vaccine clinical trials in China and referencing relevant laws, regulations,and technical guidelines, we discuss the key control measures in the implementation of vaccine clinical trials under different design scenarios, including organizational management, safety assessment of trial vaccines, determination of immunogenicity and protective efficacy endpoints, blinding maintenance during the trial, the process of informed consent signing, and compliance in subject follow-up. The aim is to provide the organizational management and implementation of vaccine clinical trials.更多还原