[Translation] A randomized, blinded, similar vaccine-controlled phase III clinical trial to evaluate the immunogenicity and safety of a 5-dose immunization schedule of a freeze-dried human rabies vaccine (serum-free Vero cells)
研究冻干人用狂犬病疫苗(无血清Vero细胞)免疫原性和安全性。证明首剂接种后14天,实验组免前阴性人群的抗体阳转率和抗体几何均值(GMC)非劣效于对照组。全程免疫后14天,实验组免前阴性人群的抗体阳性率非劣效于对照组。评价受试人群以5剂免疫程序接种试验疫苗的安全性。
[Translation] To study the immunogenicity and safety of freeze-dried human rabies vaccine (serum-free Vero cells). To prove that 14 days after the first dose, the antibody conversion rate and antibody geometric mean (GMC) of the pre-immunization negative population in the experimental group were non-inferior to those in the control group. 14 days after the full course of immunization, the antibody positivity rate of the pre-immunization negative population in the experimental group was non-inferior to that of the control group. To evaluate the safety of the experimental population inoculated with the test vaccine in a 5-dose immunization schedule.