EV71 vaccine(Enimmune)(EV71 vaccine(Enimmune)) - 在研适应症：肠道病毒感染_专利_临床

概要

基本信息

药物类型

预防性疫苗

别名-

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染

在研适应症

肠道病毒感染

非在研适应症-

原研机构

Enimmune Corp.

在研机构

Enimmune Corp.

非在研机构-

权益机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 EV71 vaccine(Enimmune) 相关的临床试验

NCT05099029

/ Active, not recruiting临床3期

A Phase III, Multiple-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of an Adjuvanted, Inactivated Enterovirus 71 (EV71) Vaccine in Healthy Infants and Children

The objectives of this study are to evaluate the EV71vaccine efficacy, immune response and safety profiles after two injections of the cell culture-based inactivated EV71 vaccine with adjuvant Al(OH)3 administrated in pediatric population aged 2 months to 6 years old.

开始日期2018-06-27

申办/合作机构

Enimmune Corp.

NCT03268083

/ Completed临床2期

An Open-Label, Dose-Finding, Phase II Study to Evaluate the Immunogenicity and Safety of the Bioreactor-generated EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 2 to 35 Months Old

The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant Al(OH)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2 to 35 months old infants/toddlers.

开始日期2016-07-01

申办/合作机构

Enimmune Corp.

NCT02777411

/ Completed临床2期

An Open-label, Dose-finding, Phase II Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old

The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant AlPO4 at 0.5-μg, 1-μg, 2-μg and 5-μg dose (if required) in children aged 3 to 6 years old and 0.25-μg (if required), 0.5-μg, 1-μg and 2-μg (if required) in 6 to 35 months old infants/toddlers.

开始日期2014-12-01

申办/合作机构

Enimmune Corp.

100 项与 EV71 vaccine(Enimmune) 相关的临床结果

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100 项与 EV71 vaccine(Enimmune) 相关的转化医学

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100 项与 EV71 vaccine(Enimmune) 相关的专利（医药）

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100 项与 EV71 vaccine(Enimmune) 相关的药物交易

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