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Clinical Trials associated with Influenza vaccine (split virion, quadrivalent)(Anhui Zhifei Longcom Biopharmaceutical)A Randomized, Blind, Position-controlled Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Quadrivalent Influenza Virus Split Vaccine in 6-35 Months of Age
A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose (0.5ml/ dose) group and the control group in a ratio of 1:1:1. They were inoculated with 2 doses of quadrivalent influenza virus split vaccine (experimental vaccine or control vaccine) at 0 and 28 days of immunization program to observe the Immunogenicity and safety.
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 people aged 6-35 months
主要目的:评价在6-35月龄儿童按0、28天程序接种2剂高剂量试验疫苗(0.5ml/剂)或低剂量试验疫苗(0.25ml/剂),全程接种30天后的免疫原性。
次要目的:评价在6-35月龄儿童按0、28天程序接种2剂高剂量试验疫苗(0.5ml/剂)或低剂量试验疫苗(0.25ml/剂)的安全性。
[Translation] Primary objective: To evaluate the immunogenicity of children aged 6-35 months who received 2 doses of high-dose experimental vaccine (0.5 ml/dose) or low-dose experimental vaccine (0.25 ml/dose) on a 0- and 28-day schedule, 30 days after the full vaccination.
Secondary objective: To evaluate the safety of children aged 6-35 months who received 2 doses of high-dose experimental vaccine (0.5 ml/dose) or low-dose experimental vaccine (0.25 ml/dose) on a 0- and 28-day schedule.
评价四价流感病毒裂解疫苗按不同剂量在6~35月龄人群中接种的安全性和免疫原性的单中心、随机、盲法Ⅰ期临床试验
[Translation] A single-center, randomized, blinded phase I clinical trial to evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine at different doses in people aged 6 to 35 months
主要目的:四价流感病毒裂解疫苗按不同剂量在6~35月龄人群中接种的安全性。 免疫原性探索性目的(适用于第二阶段):探索四价流感病毒裂解疫苗按不同剂量在6~35月龄人群中接种的免疫原性。
[Translation] Primary objective: To investigate the safety of different doses of quadrivalent influenza virus split vaccine in people aged 6 to 35 months. Immunogenicity Exploratory objective (applicable to Phase II): To investigate the immunogenicity of different doses of quadrivalent influenza virus split vaccine in people aged 6 to 35 months.
100 Clinical Results associated with Influenza vaccine (split virion, quadrivalent)(Anhui Zhifei Longcom Biopharmaceutical)
100 Translational Medicine associated with Influenza vaccine (split virion, quadrivalent)(Anhui Zhifei Longcom Biopharmaceutical)
100 Patents (Medical) associated with Influenza vaccine (split virion, quadrivalent)(Anhui Zhifei Longcom Biopharmaceutical)
100 Deals associated with Influenza vaccine (split virion, quadrivalent)(Anhui Zhifei Longcom Biopharmaceutical)