1
Clinical Trials associated with Rabies Vaccine(Vero Cell)(Anhui Zhifei Longcom Biologic Pharmacy) / Active, not recruitingPhase 3 随机、盲法、同类疫苗对照评价冻干人用狂犬病疫苗(Vero细胞)5剂程序和4剂(2-1-1)程序的免疫原性和安全性的Ⅲ期临床试验
[Translation] A randomized, blinded, similar vaccine-controlled phase III clinical trial to evaluate the immunogenicity and safety of a 5-dose schedule and a 4-dose (2-1-1) schedule of freeze-dried human rabies vaccine (Vero cells)
证明在免前抗体阴性人群中,以5剂程序接种试验疫苗或对照疫苗,首剂疫苗接种后14天,5剂试验组的免疫原性非劣效于5剂对照组;
证明在免前抗体阴性人群中,以4剂程序接种试验疫苗或对照疫苗,首剂疫苗接种后14天,4剂试验组的免疫原性非劣效于4剂对照组;
与同类上市疫苗比较,评价接种试验疫苗的安全性。
[Translation] Prove that in the population with negative pre-immune antibodies, the test vaccine or control vaccine is vaccinated with a 5-dose schedule, and 14 days after the first dose of the vaccine, the immunogenicity of the 5-dose test group is non-inferior to that of the 5-dose control group;
Prove that in the population with negative pre-immune antibodies, the test vaccine or control vaccine is vaccinated with a 4-dose schedule, and 14 days after the first dose of the vaccine, the immunogenicity of the 4-dose test group is non-inferior to that of the 4-dose control group;
Compare with similar marketed vaccines, evaluate the safety of vaccination with the test vaccine.
100 Clinical Results associated with Rabies Vaccine(Vero Cell)(Anhui Zhifei Longcom Biologic Pharmacy)
100 Translational Medicine associated with Rabies Vaccine(Vero Cell)(Anhui Zhifei Longcom Biologic Pharmacy)
100 Patents (Medical) associated with Rabies Vaccine(Vero Cell)(Anhui Zhifei Longcom Biologic Pharmacy)
100 Deals associated with Rabies Vaccine(Vero Cell)(Anhui Zhifei Longcom Biologic Pharmacy)