Target- |
MechanismImmunostimulants |
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Inactive Indication- |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Not yet recruitingPhase 3 评价四价流感病毒裂解疫苗在3周岁及以上人群中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 3 years and above
评价四价流感病毒裂解疫苗在3周岁及以上人群中的免疫原性和安全性
[Translation] Evaluation of the immunogenicity and safety of quadrivalent influenza virus split vaccine in people aged 3 years and above
/ Active, not recruitingPhase 1 评价四价流感病毒裂解疫苗在 6-35 月龄和 3 岁及以上健康人群中接种安全性和免疫原性的开放、单臂Ⅰ期临床试验
[Translation] An open, single-arm phase I clinical trial to evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy subjects aged 6-35 months and 3 years and above
1、主要目的
初步评价 15μg/亚型/剂四价流感病毒裂解疫苗(0.5ml,预灌封)以全程单剂免疫程序在 3 岁及以上健康人群中接种和 7.5μg/亚型/剂四价流感病毒裂解疫苗(0.25ml,预灌封)以全程两剂(间隔 28 天)免疫程序在 6-35 月龄健康婴幼儿中接种的安全性。
2、次要目的
初步评价 15μg/亚型/剂四价流感病毒裂解疫苗(0.5ml,预灌封)以全程单剂免疫程序在 3 岁及以上健康人群中接种和 7.5μg/亚型/剂四价流感病毒裂解疫苗(0.25ml,预灌封)以全程两剂(间隔 28 天)免疫程序在 6-35 月龄健康婴幼儿中接种的免疫原性。
[Translation] 1. Primary objective
To preliminarily evaluate the safety of 15μg/subtype/dose quadrivalent influenza virus split vaccine (0.5ml, prefilled) in a full single-dose immunization schedule in healthy people aged 3 years and above, and 7.5μg/subtype/dose quadrivalent influenza virus split vaccine (0.25ml, prefilled) in a full two-dose immunization schedule (28 days apart) in healthy infants and young children aged 6-35 months.
2. Secondary objective
To preliminarily evaluate the immunogenicity of 15μg/subtype/dose quadrivalent influenza virus split vaccine (0.5ml, prefilled) in a full single-dose immunization schedule in healthy people aged 3 years and above, and 7.5μg/subtype/dose quadrivalent influenza virus split vaccine (0.25ml, prefilled) in a full two-dose immunization schedule (28 days apart) in healthy infants and young children aged 6-35 months.
100 Clinical Results associated with Changchun Haijiya Biotechnology Co., Ltd.
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