Influenza A (H5N1) virus monovalent vaccine(ID Biomedical Corporation of Quebec)(Influenza A (H5N1) virus monovalent vaccine(ID Biomedical Corporation of Quebec))

概要

基本信息

药物类型

预防性疫苗

别名

AREPANRIX、Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

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

H5N1流感甲型流感病毒感染流感病毒感染

原研机构

ID Biomedical Corporation of Quebec

在研机构-

非在研机构

GSK PlcID Biomedical Corporation of Quebec

权益机构-

最高研发阶段撤市

首次获批日期

美国 (2013-11-22),

H5N1流感

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

关联

7

项与 Influenza A (H5N1) virus monovalent vaccine(ID Biomedical Corporation of Quebec) 相关的临床试验

NCT02719743

/ Completed临床2期

An Observer-blind, Dose Ranging Safety and Immunogenicity Study of GSK Biologicals' GSK1557484A Vaccine in Children 6 to Less Than 36 Months of Age

The purpose of this study is to assess the safety and immunogenicity of different formulations of GSK Biologicals' influenza candidate vaccine GSK1557484A, in children 6-35 months of age.

开始日期2016-07-07

申办/合作机构

GSK Plc

NCT01788228

/ Completed临床3期

Safety and Tolerability of GSK 1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure

The purpose of this study is to evaluate the safety and tolerability of GSK Biologicals' vaccine GSK1557484A against pandemic avian (H5N1) influenza in adults at occupational risk of exposure to the virus.

开始日期2013-03-22

申办/合作机构

GSK Plc

NCT01416571

/ Completed临床2期

Immunogenicity and Safety Study of GSK Biologicals' Monovalent Pandemic H5N1 Vaccine 1557484A in Adults Aged 18 - 64 Years

This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A, prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when administered up to 5 years following production.

开始日期2011-08-12

申办/合作机构

GSK Plc

100 项与 Influenza A (H5N1) virus monovalent vaccine(ID Biomedical Corporation of Quebec) 相关的临床结果

登录后查看更多信息

100 项与 Influenza A (H5N1) virus monovalent vaccine(ID Biomedical Corporation of Quebec) 相关的转化医学

登录后查看更多信息

100 项与 Influenza A (H5N1) virus monovalent vaccine(ID Biomedical Corporation of Quebec) 相关的专利（医药）

登录后查看更多信息

2

项与 Influenza A (H5N1) virus monovalent vaccine(ID Biomedical Corporation of Quebec) 相关的文献（医药）

2016-09-01·Human Vaccines & Immunotherapeutics3区 · 医学

Evaluation of potential immunogenicity differences between Pandemrix™ and Arepanrix™

3区 · 医学

Article

作者: Canelle, Quentin ; Innis, Bruce L ; van der Most, Robbert ; Dewé, Walthère

In retrospective observational studies, an increased relative risk of incident narcolepsy was observed in some European countries among recipients of the AS03-adjuvanted, A(H1N1)pdm09, inactivated, detergent-split virion vaccine Pandemrix™ manufactured in Dresden, Germany (D-Pan H1N1). A similar increased risk was not observed in a retrospective population-based study in individuals in Quebec province, Canada, who received Aprepanrix™, a Quebec-manufactured AS03-adjuvanted A(H1N1)pdm09 inactivated, detergent-split virion vaccine (Q-Pan H1N1). Antibody responses in D-Pan versus Q-Pan vaccinees (adults/children) measured as hemagglutination inhibition (HI) titers 21 d post-vaccination were found to be equivalent (NCT01161160). The current post-hoc analysis was conducted to determine whether antibody avidity differed following immunization with the 2 vaccines. Using surface plasmon resonance, we evaluated the capacity of serum specimens (drawn from the comparative immunogenicity trial) from a subset of subjects aged 3-9 y who received either D-Pan or Q-Pan (N = 28/group), to bind to recombinant A(H1N1)pdm09 hemagglutinin. IgG antibodies were purified from Day 21 sera. Binding was assessed by end association level; dissociation by retention of antigen-antibody complexes at the end of the dissociation phase, and kd. Inter-run variability for the control monoclonal antibody, association levels and dissociation levels was low (CVs 1.3%, 7.8% and 1.4%, respectively); non-specific binding was negligible. High avidity and slow dissociation was observed for both groups (kd ≤ 10(-4)/s; geometric mean [IQR] association and dissociation levels for D-Pan/Q-Pan: 15.4 RU [13.4-17.7]/12.4 RU [10.8-14.3] and 94.5% [92.5-96.5]/95.5% [93.5-97.6], respectively). Association, but not dissociation levels correlated with HI titers. No significant differences in avidity parameters were observed between D-Pan and Q-Pan sera.

2012-01-01·HIV Clinical Trials

High-Level Immunogenicity Is Achieved Vaccine With Adjuvanted Pandemic H1N1<sub>2009</sub> and Improved With Booster Dosing in a Randomized Trial of HIV-Infected Adults

Article

作者: Walmsley, Sharon ; Cooper, Curtis ; Haase, David ; Klein, Marina ; Smith, Bruce ; Marty, Kimberley ; MacKinnon-Cameron, Donna ; Law, Barb ; Scheifele, David ; Halperin, Scott ; Li, Yan

BACKGROUNDMore severe influenza disease and poor vaccine immunogenicity in HIV-infected patients necessitate improved immunization strategies to maximize vaccine efficacy.METHODSA phase III, randomized trial was conducted at 4 Canadian sites. Two dosing strategies (standard dose vs standard dose plus booster on day 21) were assessed in HIV patients aged 20 to 59 years during the H1N1(2009) pandemic. A single antigen, inactivated split adjuvanted (AS03(A)) influenza vaccine (Arepanrix) was utilized. Serum hemagglutination inhibition (HAI) titres were assessed at days 21 and 42 and at month 6.RESULTS150 participants received at least one injection. Baseline parameters were similar between groups: 83% male, 85% on HAART, median CD4 = 519 cells/mm(3), 84% with HIV RNA < 50 copies/mL. At day 21, seroprotection (HAI ≥1:40) was achieved in 80% (95% CI, 70-89) of participants. Seroconversion occurred in 74% (63-85). Seroprotection and seroconversion were further improved in those randomized to booster dosing: day 42, 94% (85-98) versus 73% (60-83) (P < .01) and 86% (75-93) versus 66% (5-77) (P = .01). Seroprotec-tion was retained in 40% (28-54) of recipients at month 6 with trends toward greater retention of immunity in booster recipients.CONCLUSIONHigh-level immunogenicity was achieved with a single dose of this adjuvanted vaccine. Immunogenicity was further improved with booster dosing. Use of this adjuvanted vaccine and booster represent an important approach to increasing immunogenicity in this vaccine hypo-responsive population.

100 项与 Influenza A (H5N1) virus monovalent vaccine(ID Biomedical Corporation of Quebec) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07BB01	-

研发状态

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
甲型流感病毒感染	临床前	美国	GSK Plc	2013-03-22
流感病毒感染	临床前	加拿大	GSK Plc	2008-01-23

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02719743 (CTgov)	临床2期	流感病毒感染	185	Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A). (H5N1 Formulation 1 Group)	積蓋簾積鑰憲鹽淵顧醖(鏇構憲鑰構積願廠鑰窪) = 壓餘積淵積遞鑰築鹽構醖蓋窪餘顧網憲襯廠鹽 (鑰獵蓋繭壓廠觸淵廠製, 糧願鹽蓋憲構鏇製糧壓 ~ 壓襯觸繭餘衊糧廠鑰積) 更多	-	2019-06-03
				Influenza A (H5N1) Virus monovalent vaccine+GSK1557484A (H5N1 Formulation 2 Group)	積蓋簾積鑰憲鹽淵顧醖(鏇構憲鑰構積願廠鑰窪) = 窪廠餘簾鬱願淵蓋網鑰醖蓋窪餘顧網憲襯廠鹽 (鑰獵蓋繭壓廠觸淵廠製, 廠築範鏇夢觸鏇襯觸夢 ~ 襯膚醖願築衊鹽積鏇鏇) 更多
NCT01788228 (CTgov)	临床3期	甲型流感病毒感染	50	Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) (Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group)	(築鏇鹽夢鏇鏇範鹹觸構) = 襯鑰鏇糧膚製鹽廠鑰構襯蓋觸窪願壓醖淵壓夢 (選鬱鏇窪範艱簾糧範壓, 餘獵鹽鏇鹽齋觸鹽選糧 ~ 艱鏇觸壓糧鏇顧艱構築) 更多	-	2015-04-07
				Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) (Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group)	(築鏇鹽夢鏇鏇範鹹觸構) = 廠鹽鹹淵餘簾艱糧構鑰襯蓋觸窪願壓醖淵壓夢 (選鬱鏇窪範艱簾糧範壓, 鏇鹽壓憲繭憲醖廠憲積 ~ 製顧糧製鹹艱鏇簾獵壓) 更多
NCT01416571 (CTgov)	临床2期	流感病毒感染	78	Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted	窪選範遞鬱艱鏇構鬱衊(獵鬱夢積衊願糧繭鹽淵) = 鏇鏇憲選選鹽壓膚遞憲艱襯衊獵製醖選觸憲觸 (糧築遞鬱夢壓襯鹽廠醖, 糧壓壓淵鹹壓鏇積醖網 ~ 鹽願顧簾鏇淵繭齋夢選) 更多	-	2014-04-16