Target- |
MechanismImmunostimulants |
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|
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Inactive Indication- |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
MechanismImmunostimulants |
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
随机、盲法、同类疫苗对照评价冻干人用狂犬病疫苗(无血清Vero细胞)5剂免疫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 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.
/ Active, not recruitingPhase 3 随机、盲法、阳性对照评价风疹减毒活疫苗(无血清MRC-5细胞)接种于18-50岁人群的免疫原性和安全性的Ⅲ期临床试验
[Translation] A randomized, blinded, positive-controlled phase III clinical trial to evaluate the immunogenicity and safety of live attenuated rubella vaccine (serum-free MRC-5 cells) in people aged 18-50 years
评价试验疫苗在18-50岁人群中接种的免疫原性和安全性
[Translation] To evaluate the immunogenicity and safety of the experimental vaccine in people aged 18-50 years
开放、单臂、单中心评价风疹减毒活疫苗(无血清MRC-5细胞)接种于18周岁及以上人群的安全性的I期临床试验
[Translation] An open, single-arm, single-center phase I clinical trial to evaluate the safety of live attenuated rubella vaccine (serum-free MRC-5 cells) in people aged 18 years and above
评价风疹减毒活疫苗(无血清MRC-5细胞)接种于18周岁及以上人群的安全性。
[Translation] To evaluate the safety of live attenuated Rubella vaccine (serum-free MRC-5 cells) in people aged 18 years and above.
100 Clinical Results associated with Tianjin Genstar Biotech Co., Ltd.
0 Patents (Medical) associated with Tianjin Genstar Biotech Co., Ltd.
100 Deals associated with Tianjin Genstar Biotech Co., Ltd.
100 Translational Medicine associated with Tianjin Genstar Biotech Co., Ltd.