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Clinical Trials associated with Rabies Vaccine(MRC-5 Cell)(Anhui Zhifei Longcom Biologic Pharmacy) / Active, not recruitingPhase 3 冻干人用狂犬病疫苗(MRC-5细胞)5剂程序和4剂程序的免疫原性和安全性的随机、盲法、同类疫苗对照的Ⅲ期临床试验
[Translation] A randomized, blinded, similar vaccine-controlled phase III clinical trial of the immunogenicity and safety of a 5-dose schedule and a 4-dose schedule of freeze-dried human rabies vaccine (MRC-5 cells)
在10-60岁人群中:证明以5剂程序接种试验疫苗,首剂接种后14天,5剂试验组的免疫原性非劣效于对照组(5剂);证明以4剂程序接种试验疫苗,首剂接种后14天,4剂试验组的免疫原性非劣效于对照组(5剂);证明以5剂程序或4剂程序接种试验疫苗,全程接种后14天,抗体阳转率均达到100%;评价接种试验疫苗的安全性。
[Translation] In the population aged 10-60 years: It was demonstrated that when the trial vaccine was administered with a 5-dose schedule, 14 days after the first dose, the immunogenicity of the 5-dose trial group was non-inferior to that of the control group (5 doses); It was demonstrated that when the trial vaccine was administered with a 4-dose schedule, 14 days after the first dose, the immunogenicity of the 4-dose trial group was non-inferior to that of the control group (5 doses); It was demonstrated that when the trial vaccine was administered with a 5-dose schedule or a 4-dose schedule, 14 days after the full vaccination, the antibody seroconversion rate reached 100%; The safety of vaccination with the trial vaccine was evaluated.
100 Clinical Results associated with Rabies Vaccine(MRC-5 Cell)(Anhui Zhifei Longcom Biologic Pharmacy)
100 Translational Medicine associated with Rabies Vaccine(MRC-5 Cell)(Anhui Zhifei Longcom Biologic Pharmacy)
100 Patents (Medical) associated with Rabies Vaccine(MRC-5 Cell)(Anhui Zhifei Longcom Biologic Pharmacy)
100 Deals associated with Rabies Vaccine(MRC-5 Cell)(Anhui Zhifei Longcom Biologic Pharmacy)