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Clinical Trials associated with Rabies Vaccine(Hualan Biological Bacterin)评价暴露后按照4剂或5剂基础免疫接种冻干人用狂犬病疫苗(Vero细胞)后的抗体持久性及观察2剂加强免疫后效果的Ⅳ期临床研究
[Translation] A phase IV clinical study to evaluate the antibody persistence after 4 or 5 doses of primary immunization with freeze-dried human rabies vaccine (Vero cells) and to observe the effect of 2 doses of booster immunization
主要目的:
评价暴露后按照4剂免疫程序(2-1-1)或者5剂免疫程序(1-1-1-1-1)基础免疫全程接种华兰生物疫苗股份有限公司(以下简称“华兰生物”或“申办方”)正常市售冻干人用狂犬病疫苗(Vero细胞)(以下简称“试验疫苗”)的抗体持久性。为再暴露的加强免疫提供科学的临床依据。
次要目的:
评价暴露后按照4剂免疫程序(2-1-1)或者5剂免疫程序(1-1-1-1-1)基础免疫全程接种试验疫苗的安全性。
评价完成暴露后基础免疫全程接种的人群在不同时间节点进行2剂(0,3天)加强免疫试验疫苗的免疫原性和安全性。
[Translation] Main purpose:
To evaluate the antibody persistence of the normal commercially available freeze-dried human rabies vaccine (Vero cells) (hereinafter referred to as the "experimental vaccine") of Hualan Bio-Vaccine Co., Ltd. (hereinafter referred to as "Hualan Bio-Vaccine" or "the sponsor") after the 4-dose immunization schedule (2-1-1) or 5-dose immunization schedule (1-1-1-1-1) after exposure. Provide scientific clinical basis for booster immunization after re-exposure.
Secondary purpose:
To evaluate the safety of the experimental vaccine after the 4-dose immunization schedule (2-1-1) or 5-dose immunization schedule (1-1-1-1-1) after exposure.
To evaluate the immunogenicity and safety of the experimental vaccine after 2 doses (0, 3 days) of booster immunization at different time points for people who have completed the full course of basic immunization after exposure.
评价冻干人用狂犬病疫苗(Vero细胞)免疫原性和安全性的随机、盲法、同类疫苗对照试验的Ⅲ期临床试验
[Translation] A randomized, blinded, similar vaccine-controlled phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (Vero cells)
评价华兰生物研制的冻干人用狂犬病疫苗(Vero细胞)在9岁~65岁健康人群中以两种不同免疫程序接种后的安全性和免疫原性
[Translation] To evaluate the safety and immunogenicity of the freeze-dried human rabies vaccine (Vero cells) developed by Hualan Biotechnology in healthy people aged 9 to 65 years after two different immunization schedules
Evaluation With Rabies Vaccine (Vero Cell) of Two Different Immune Procedure in the Healthy Crowd the Immunogenicity and Safety of Randomized, Blinded, Similar Vaccine Against Ⅲ Phase of Clinical Trials
To evaluate the safety and immunogenicity of lyophilized human rabies vaccine (Vero cell) developed by Hualan Biological in healthy people aged 9 to 65 years with two different immunization schedules.
100 Clinical Results associated with Rabies Vaccine(Hualan Biological Bacterin)
100 Translational Medicine associated with Rabies Vaccine(Hualan Biological Bacterin)
100 Patents (Medical) associated with Rabies Vaccine(Hualan Biological Bacterin)
100 Deals associated with Rabies Vaccine(Hualan Biological Bacterin)