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更新于：2025-07-08

Cell culture-derived influenza subunit vaccine(Novartis AG)

更新于：2025-07-08

概要

概要

基本信息

药物类型

预防性疫苗

别名

A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like, and B/Malaysia/ 2506/2004-like、cell culture-derived trivalent influenza vaccine、cTIV

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病

在研适应症-

非在研适应症

流感病毒感染

原研机构

Novartis AG

在研机构-

非在研机构

Novartis AG

权益机构-

最高研发阶段无进展临床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

项与 Cell culture-derived influenza subunit vaccine(Novartis AG) 相关的临床试验

NCT00645411

/ Completed临床2/3期

A Combined Phase II/III, Observer-Blind, Randomized, Multi-center Study to Evaluate Safety, Tolerability and Immunogenicity of Trivalent Subunit Influenza Vaccines, Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Children and Adolescents

The present study is the first study designed to evaluate safety, tolerability and immunogenicity of the cell culture-derived influenza vaccine in healthy children and adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and safety will be assessed in children and adolescents 9 to 17 years of age (Cohort 1) prior to enrolling additional children and adolescents 9 to 17 years of age (Cohort 2) and children 3 to 8 years of age (Cohort 3).

开始日期2007-10-01

申办/合作机构

Novartis AG

NCT00579345

/ Completed临床3期

A Phase III, Single-Blind, Multi-Center, Extension Study to Evaluate Safety and Tolerability of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adult and Elderly Subjects Who Participated in Study V58P4, With Subset Analyses of Immunogenicity and Evaluation of Concomitant Polysaccharide Pneumococcal Vaccine (Elderly).

The study primarily aims to evaluate immunogenicity and safety of influenza vaccines (cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)) when administered alone and when administered concomitantly with pneumococcal polysaccharide vaccine (PV) in elderly subjects. The study also aimed to evaluate safety and immunogenicity (subset) of annual vaccination with either cTIV or eTIV_a in adults and elderly subjects.

开始日期2007-10-01

申办/合作机构

Novartis AG

NCT00492063

/ Completed临床3期

A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture and of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects

The present study aims to evaluate the safety and immunogenicity of the new influenza subunit vaccine produced in Madin Darby Canine Kidney (MDCK) cells in healthy adult and elderly subjects.

开始日期2004-09-01

申办/合作机构

Novartis Pharma AG

100 项与 Cell culture-derived influenza subunit vaccine(Novartis AG) 相关的临床结果

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100 项与 Cell culture-derived influenza subunit vaccine(Novartis AG) 相关的转化医学

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100 项与 Cell culture-derived influenza subunit vaccine(Novartis AG) 相关的专利（医药）

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100 项与 Cell culture-derived influenza subunit vaccine(Novartis AG) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
流感病毒感染	临床3期	美国	Novartis AG	2007-10-01
流感病毒感染	临床3期	意大利	Novartis AG	2007-10-01
流感病毒感染	临床3期	波兰	Novartis AG	2007-10-01