Application of cluster randomization design in vaccine clinical trials
10.3760/cma.j.cn112338-20210622-00491
- VernacularTitle:整群随机设计在疫苗临床试验中的应用
- Author:
Shuyu GAO
1
;
Jingxin LI
;
Pengfei JIN
;
Fengcai ZHU
Author Information
1. 东南大学公共卫生学院，南京 210009
- Keywords:
Vaccine;
Clinical trial;
Herd protection
- From:
Chinese Journal of Epidemiology
2021;42(12):2221-2225
- CountryChina
- Language:Chinese
-
Abstract:
When the coverage of the vaccinated people reaches a certain percentage of the population, the herd protection will protect the unvaccinated persons. However, the traditional clinical evaluation of vaccines performing individual randomized design fails to evaluate the herd protection of vaccines. Compared with the individual randomized design, the cluster-randomized design can determine the overall protection by the vaccine more comprehensively. It has become increasingly common to perform a cluster-randomized design in clinical trials of vaccines in Phase Ⅲ and Ⅳ clinical trials. However, little is known about the application of cluster randomized design in vaccine clinical trials in China. We, at this moment, do a review of the application of random cluster design in vaccine clinical trials and provide references for future research in China.
