[Translation] A phase III randomized, blinded, similar vaccine-controlled trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (Vero cells) and the efficacy of a simplified 4-injection schedule
采用非劣效试验方法,通过与同类上市疫苗(对照疫苗)比较,评价“冻干人用狂犬病疫苗(Vero细胞)”制品(试验疫苗)的免疫原性、免疫持久性和安全性;与此同时,通过与5剂免疫程序比较,评价4剂程序的免疫效果。
[Translation] The non-inferiority test method was used to evaluate the immunogenicity, immune persistence and safety of the "lyophilized human rabies vaccine (Vero cell)" product (experimental vaccine) by comparing it with similar marketed vaccines (control vaccine); at the same time, the immune effect of the 4-dose program was evaluated by comparing it with a 5-dose immunization program.