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Clinical Trials associated with Influenza Vaccine (Split Virion), Inactivated, Quadrivalent (Shenzhen Kangtai)评价四价流感病毒裂解疫苗在6~35月龄人群中接种的安全性和初步免疫原性的随机、盲法、阳性对照Ⅰ期临床试验
[Translation] A randomized, blinded, positive-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of a quadrivalent influenza virus split vaccine in people aged 6 to 35 months
主要目的:评价四价流感病毒裂解疫苗在6~35月龄人群中接种的安全性。
次要目的:评价四价流感病毒裂解疫苗在6~35月龄人群中接种的免疫原性。
[Translation] Primary objective: To evaluate the safety of quadrivalent influenza virus split vaccine in individuals aged 6 to 35 months.
Secondary objective: To evaluate the immunogenicity of quadrivalent influenza virus split vaccine in individuals aged 6 to 35 months.
评价四价流感病毒裂解疫苗在3岁及以上健康人群中接种的免疫原性和安全性的随机、盲法、阳性对照III期临床试验
[Translation] A randomized, blinded, positive-controlled phase III clinical trial to evaluate the immunogenicity and safety of quadrivalent influenza virus split vaccine in healthy people aged 3 years and above
主要目的:(1)证明3岁及以上健康人群接种1剂四价流感病毒裂解疫苗28天后,4种疫苗型别HI抗体血清阳转率(SCR)和几何平均滴度(GMT)均非劣效于对照组相同型别;(2)评价60岁以下健康人群接种1剂试验疫苗28天后,4种疫苗型别HI抗体SCR和血清保护率(SPR);(3)评价60岁及以上健康人群接种1剂试验疫苗28天后,4种疫苗型别HI抗体SCR和SPR。次要目的:(1)评价在3岁及以上健康人群中接种1剂四价流感病毒裂解疫苗的免疫原性;(2)评价在3岁及以上健康人群中接种1剂四价流感病毒裂解疫苗的安全性。
[Translation] Primary objectives: (1) To demonstrate that 28 days after one dose of quadrivalent influenza virus split vaccine was administered to healthy people aged 3 years and above, the seroconversion rate (SCR) and geometric mean titer (GMT) of HI antibodies of the four vaccine types were non-inferior to those of the same type in the control group; (2) To evaluate the SCR and seroprotection rate (SPR) of HI antibodies of the four vaccine types in healthy people under 60 years of age 28 days after one dose of the trial vaccine; (3) To evaluate the SCR and SPR of HI antibodies of the four vaccine types in healthy people aged 60 years and above 28 days after one dose of the trial vaccine. Secondary objectives: (1) To evaluate the immunogenicity of one dose of quadrivalent influenza virus split vaccine in healthy people aged 3 years and above; (2) To evaluate the safety of one dose of quadrivalent influenza virus split vaccine in healthy people aged 3 years and above.
评价四价流感病毒裂解疫苗在3岁及以上健康人群中接种的安全性和免疫原性的单中心、开放Ⅰ期临床试验
[Translation] A single-center, open-label phase I clinical trial to evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy people aged 3 years and above
主要目的:评价在3岁及以上健康人群中接种1剂四价流感病毒裂解疫苗的安全性。次要目的:初步评价在3岁及以上健康人群中接种1剂四价流感病毒裂解疫苗的免疫原性。
[Translation] Primary objective: To evaluate the safety of one dose of quadrivalent influenza virus split vaccine in healthy people aged 3 years and above. Secondary objective: To preliminarily evaluate the immunogenicity of one dose of quadrivalent influenza virus split vaccine in healthy people aged 3 years and above.
100 Clinical Results associated with Influenza Vaccine (Split Virion), Inactivated, Quadrivalent (Shenzhen Kangtai)
100 Translational Medicine associated with Influenza Vaccine (Split Virion), Inactivated, Quadrivalent (Shenzhen Kangtai)
100 Patents (Medical) associated with Influenza Vaccine (Split Virion), Inactivated, Quadrivalent (Shenzhen Kangtai)
100 Deals associated with Influenza Vaccine (Split Virion), Inactivated, Quadrivalent (Shenzhen Kangtai)