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Clinical Trials associated with Influenza Vaccine (Split Virion), Inactivated, Quadrivalent (Toyouvax)四价流感病毒裂解疫苗(MDCK细胞)接种于6月龄及以上健康人群的安全性、耐受性及初步探索免疫原性的单中心、盲法、安慰剂与阳性疫苗平行对照设计的Ⅰ期临床试验
[Translation] A single-center, blinded, placebo- and positive vaccine-controlled phase I clinical trial of the safety, tolerability, and preliminary exploration of immunogenicity of quadrivalent influenza virus split vaccine (MDCK cells) in healthy people aged 6 months and above
主要目的:
四价流感病毒裂解疫苗(MDCK细胞)在6月龄及以上健康人群中接种的安全性。
次要目的:
四价流感病毒裂解疫苗(MDCK细胞)在6月龄及以上健康人群中接种的免疫原性。
探索性目的:
探索3~8岁人群以2种免疫程序接种四价流感病毒裂解疫苗(MDCK细胞)的免疫原性。
[Translation] Primary objective:
Safety of quadrivalent influenza virus split vaccine (MDCK cells) in healthy people aged 6 months and above.
Secondary objective:
Immunogenicity of quadrivalent influenza virus split vaccine (MDCK cells) in healthy people aged 6 months and above.
Exploratory objective:
Explore the immunogenicity of quadrivalent influenza virus split vaccine (MDCK cells) in 2 immunization schedules in people aged 3 to 8 years.
四价流感病毒裂解疫苗(成人规格)在中国 3 岁及以上健康人群中进行的单中心、随机、双盲、同类制品平行对照Ⅲ期临床试验
[Translation] A single-center, randomized, double-blind, parallel-controlled phase III clinical trial of quadrivalent influenza virus split vaccine (adult specification) in healthy people aged 3 years and above in China
主要目的:评价试验疫苗在 3 周岁及以上人群中接种的免疫原性。
次要目的:评价试验疫苗在 3 周岁及以上人群中接种的安全性。
[Translation] Primary objective: To evaluate the immunogenicity of the trial vaccine in people aged 3 years and above.
Secondary objective: To evaluate the safety of the trial vaccine in people aged 3 years and above.
四价流感病毒裂解疫苗(成人规格)在中国3岁及以上健康人群中进行的单中心、开放式设计I/II期临床试验
[Translation] A single-center, open-label phase I/II clinical trial of quadrivalent influenza virus split vaccine (adult specification) in healthy people aged 3 years and above in China
主要目的是初步评价四价流感病毒裂解疫苗的安全性和耐受性。次要目的是探索四价流感病毒裂解疫苗在 3-8 周岁人群中 2 针次免疫程序的免疫原性和安全性。所有受试者接种后观察30分钟即时反应、0~7天的全身和局部不良事件、0~28/30天不良事件,报告免后6个月严重不良事件。检测受试者免前和末次免疫后30天外周静脉血血清中HI抗体,评价试验疫苗的免疫原性。
[Translation] The primary objective is to preliminarily evaluate the safety and tolerability of the quadrivalent influenza virus split vaccine. The secondary objective is to explore the immunogenicity and safety of the two-dose immunization program of the quadrivalent influenza virus split vaccine in people aged 3-8 years. All subjects were observed for immediate reactions within 30 minutes after vaccination, systemic and local adverse events within 0-7 days, and adverse events within 0-28/30 days, and serious adverse events were reported 6 months after vaccination. HI antibodies were detected in the peripheral venous serum of the subjects before immunization and 30 days after the last immunization to evaluate the immunogenicity of the trial vaccine.
100 Clinical Results associated with Influenza Vaccine (Split Virion), Inactivated, Quadrivalent (Toyouvax)
100 Translational Medicine associated with Influenza Vaccine (Split Virion), Inactivated, Quadrivalent (Toyouvax)
100 Patents (Medical) associated with Influenza Vaccine (Split Virion), Inactivated, Quadrivalent (Toyouvax)
100 Deals associated with Influenza Vaccine (Split Virion), Inactivated, Quadrivalent (Toyouvax)