Consideration of clinical trial design for human rabies vaccines with different immunization schedules
10.3760/cma.j.cn112309-20211009-00335
- VernacularTitle:人用狂犬病疫苗不同免疫程序临床试验设计要点的考虑
- Author:
Xia DENG
1
;
Bo LIU
;
Chenyan GAO
Author Information
1. 国家药品监督管理局药品审评中心，北京 100022
- Keywords:
Human rabies vaccine;
Immunization schedule;
Clinical trial
- From:
Chinese Journal of Microbiology and Immunology
2021;41(12):974-978
- CountryChina
- Language:Chinese
-
Abstract:
This article referred to the relevant guidelines for vaccine clinical trials and the accumulated experience in the development and review of human rabies vaccines, as well as combined the technical recommendations for human rabies vaccines from major health facilities such as WHO, to discuss the key considerations in the design of clinical trials for human rabies vaccines, including control vaccines, evaluation of efficacy endpoints, clinical subjects, the sample size, immunity persistence, re-exposure immunization schedule and post-marketing study. This article aimed to provide reference for the design of human rabies vaccine clinical trials.
