脂质体流感病毒疫苗 (Crucell)(Influenza virus vaccine liposomal (Crucell))

概要

基本信息

药物类型

预防性疫苗、脂质体药物

别名

InfectoVac Flu、Inflexal V、Invivac

+ [1]

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

Crucell NV

在研机构-

非在研机构

Crucell Holland B.V.

Crucell NV

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)无进展

特殊审评-

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关联

14

项与脂质体流感病毒疫苗 (Crucell) 相关的临床试验

NCT02014168

/ Terminated临床1期IIT

A Phase I Study to Determine the Safety and Immunogenicity of Co-administration of the Candidate Influenza Vaccine MVA-NP+M1 and the Viroflu® Seasonal Influenza Vaccine

This is a single blinded placebo controlled phase I study, to assess the safety and immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with the Viroflu® seasonal influenza vaccine. All volunteers recruited will be healthy adults aged 18 and over.

开始日期2014-01-01

申办/合作机构

University of Oxford

EUCTR2013-003403-19-SE

/ Not yet recruiting临床4期IIT

Study of T- and B-cell immunity after vaccination with a virosomebased influenza vaccine (Inflexal V) in patients who have undergone hematopoietic allogeneic stem cell transplantation.

开始日期2013-09-25

申办/合作机构

Karolinska University Hospital

NCT01893177

/ Completed临床3期

Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2013/2014-season Virosomal Subunit Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations

The study is to assess whether the influenza vaccine Inflexal V for season 2013/2014 fulfills the EMA requirements for re-registration of influenza vaccines.

开始日期2013-07-01

申办/合作机构

Crucell Holland B.V.

100 项与脂质体流感病毒疫苗 (Crucell) 相关的临床结果

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100 项与脂质体流感病毒疫苗 (Crucell) 相关的转化医学

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100 项与脂质体流感病毒疫苗 (Crucell) 相关的专利（医药）

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27

项与脂质体流感病毒疫苗 (Crucell) 相关的文献（医药）

2016-10-01·Vaccine3区 · 医学

A phase 1, open-label, randomized study to compare the immunogenicity and safety of different administration routes and doses of virosomal influenza vaccine in elderly

3区 · 医学

Article

作者: Shukarev, Georgi ; Levin, Yotam ; Kochba, Efrat ; Herrera-Taracena, Guillermo ; van Damme, Pierre ; Rusch, Sarah

BACKGROUNDInfluenza remains a significant problem in elderly despite widespread vaccination coverage. This randomized, phase-I study in elderly compared different strategies of improving vaccine immunogenicity.METHODSA total of 370 healthy participants (⩾65years) were randomized equally 1:1:1:1:1:1 to six influenza vaccine treatments (approximately 60-63 participants per treatment arm) at day 1 that consisted of three investigational virosomal vaccine formulations at doses of 7.5, 15, and 45μg HA antigen/strain administered intradermally (ID) by MicronJet600™ microneedle device (NanoPass Technologies) or intramuscularly (IM), and three comparator registered seasonal vaccines; Inflexal V™ (Janssen) and MF59 adjuvanted Fluad™ (Novartis) administered IM and Intanza™ (Sanofi Pasteur) administered ID via Soluvia™ prefilled microinjection system (BD). Serological evaluations were performed at days 22 and 90 and safety followed-up for 6months.RESULTSIntradermal delivery of virosomal vaccine using MicronJet600™ resulted in significantly higher immunogenicity than the equivalent dose of virosomal Inflexal V™ administered intramuscularly across most of the parameters and strains, as well as in some of the readouts and strains as compared with the 45μg dose of virosomal vaccine formulation. Of 370 participants, 300 (81.1%) reported ⩾1 adverse event (AE); more participants reported solicited local AEs (72.2%) than solicited systemic AEs (12.2%).CONCLUSIONSIntradermal delivery significantly improved influenza vaccine immunogenicity compared with intramuscular delivery. Triple dose (45μg) virosomal vaccine did not demonstrate any benefit on vaccine's immunogenicity over 15μg commercial presentation. All treatments were generally safe and well-tolerated.

2013-03-18·Human Vaccines & Immunotherapeutics3区 · 医学

Head-to-head comparison of an intradermal and a virosome influenza vaccine in patients over the age of 60

3区 · 医学

Article

作者: Filippo Ansaldi ; Andrea Orsi ; Emanuela Rappazzo ; Daniela de Florentiis ; Giancarlo Icardi ; Valentina Parodi ; Martina Coppelli ; Paolo Durando

In the present study we first compare immunogenicity against vaccine and heterologous circulating A(H1N1)pdm09 strains, tolerability and safety of intradermal Intanza 15 μg and of virosomal adjuvanted, intramuscularly delivered influenza vaccine, Inflexal V, in healthy elderly volunteers. Five-hundred participants were enrolled in the study and randomly assigned to the two vaccine groups to receive either one dose of Intanza 15 μg or Inflexal V vaccine. All subjects reported solicited local and systemic reactions occurred within 7 d after vaccination and unsolicited adverse events up to 21 d post-immunization and any serious adverse event appeared during the study. A subset of 55 participants was randomly selected for immunogenicity and cross-protection evaluations. Serum samples were collected before and 1 and 3 mo after immunization. Antibody responses were measured using hemagglutination inhibition (HI) against all viruses used in the study and neutralization (NT) assays against A(H1N1)pdm09 strains. At least one of the CHMP criteria for influenza vaccine approval in the elderly was met by virosomal vaccine against all the tested viruses; intradermal vaccine met all criteria against all strains. Several parameters of immune response against strains with a different antigenic pattern from that of vaccine A/California/04/09(H1N1)pdm09 were significantly higher in the intradermal vaccine group compared with the virosomal group. Safety and systemic tolerability of both vaccines were excellent, but injection site reactions occurred significantly more frequently in the intradermal vaccination group. Immunogenicity of Intanza 15 μg intradermal vaccine tended to be higher than that of Inflexal V against heterologous strains in healthy elderly.

2013-01-01·Human Vaccines & Immunotherapeutics3区 · 医学

A matched case-control study

3区 · 医学

Article

作者: Donatella Panatto ; Stefania Rossi ; Daniela Amicizia ; Roberto Gasparini ; Piero Luigi Lai

Annual vaccination is the main mean of preventing influenza in the elderly. In order to evaluate the effectiveness of the adjuvanted seasonal influenza vaccines available in Italy in preventing hospitalization for influenza and pneumonia, a matched case-control study was performed in elderly subjects during the 2010-2011 season in Genoa (Italy). Cases and controls were matched in a 1:1 ratio according to gender, age, socio-economic status and type of influenza vaccine. Vaccine effectiveness was calculated as IVE = [(1-OR)x100] and crude odds ratios were estimated through conditional logistic regression models. Adjusted odds ratios were estimated through multivariable logistic models. In the study area, influenza activity was moderate in the 2010-2011 season, with optimal matching between circulating viruses and vaccine strains. We recruited 187 case-control pairs; 46.5% of cases and 79.1% of controls had been vaccinated. The adjuvanted influenza vaccines (Fluad (®) considered together with Inflexal V (®) ) were associated with a significant reduction in the risk of hospitalization, their effectiveness being 94.8% (CI 77.1-98.8). Adjusted vaccine effectiveness was 95.2% (CI 62.8-99.4) and 87.8 (CI 0.0-98.9) for Inflexal V (®) and Fluad (®) , respectively. Both adjuvanted vaccines proved effective, although the results displayed statistical significance only for Inflexal V (®) (p = 0.004), while for Fluad (®) statistical significance was not reached (p = 0.09). Our study is the first to provide information on the effectiveness of Inflexal V (®) in terms of reducing hospitalizations for influenza or pneumonia in the elderly, and demonstrates that this vaccine yields a high degree of protection and that its use would generate considerable saving for the National Health Service.

100 项与脂质体流感病毒疫苗 (Crucell) 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	中国	Crucell Holland B.V.	2009-10-01
流感病毒感染	临床3期	中国	Crucell Holland B.V.	2009-10-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01631110 (CTgov)	临床3期	流感病毒感染	110	Inflexal V (Elderly Subjects Aged Over 60 Years)	蓋襯積願遞衊蓋鏇鏇鏇(廠餘糧衊襯艱醖繭選鬱) = 糧襯壓構積製廠艱鹽襯網夢衊願壓糧選鹹顧壓 (遞遞壓願選網製獵簾艱, 鹹糧膚蓋膚淵鬱鹽鹽構 ~ 觸構獵醖築餘鬱糧夢淵) 更多	-	2013-12-20
				Inflexal V (Adults From 18 to 60 Years Old Inclusive)	蓋襯積願遞衊蓋鏇鏇鏇(廠餘糧衊襯艱醖繭選鬱) = 餘構選鏇選窪餘襯鏇製網夢衊願壓糧選鹹顧壓 (遞遞壓願選網製獵簾艱, 網衊鹹構製膚獵繭齋構 ~ 構範艱繭襯窪醖鏇窪顧) 更多
NCT01306305 (CTgov)	临床4期	流感病毒感染	110	Inflexal V (Adults)	網醖積窪鬱製窪遞餘夢(糧繭築鹽鬱獵廠範艱範) = 夢鹽淵獵觸鹽製鑰構繭繭齋遞鬱醖夢醖醖廠夢 (廠蓋衊蓋繭鏇壓憲繭鏇, 顧顧遞餘鬱艱衊糧鬱製 ~ 憲顧淵範構蓋夢鑰選構) 更多	-	2012-03-29
				Inflexal V (Elderly)	網醖積窪鬱製窪遞餘夢(糧繭築鹽鬱獵廠範艱範) = 鑰選遞選顧窪窪鹹鏇淵繭齋遞鬱醖夢醖醖廠夢 (廠蓋衊蓋繭鏇壓憲繭鏇, 餘襯憲選顧築網醖範鹽 ~ 膚構築獵簾積膚餘膚衊) 更多
NCT01306253 (CTgov)	临床4期	流感病毒感染	114	Inflexal V (Adults)	築簾獵襯憲範夢鹹壓襯(觸鬱簾製遞鹽製糧餘積) = 壓願簾積製鬱蓋蓋夢襯範壓憲遞襯簾鬱蓋鏇積 (繭簾願廠願憲遞鏇願夢, 艱範窪鬱廠憲鹽觸鹽遞 ~ 顧積築構鑰鹹繭壓襯膚) 更多	-	2012-01-20
				Inflexal V (Elderly)	築簾獵襯憲範夢鹹壓襯(觸鬱簾製遞鹽製糧餘積) = 積淵網鏇繭範鏇積鏇鬱範壓憲遞襯簾鬱蓋鏇積 (繭簾願廠願憲遞鏇願夢, 糧簾顧膚鹹築廠餘膚窪 ~ 積鹹獵簾範窪獵糧蓋鑰) 更多
NCT01303510 (CTgov)	临床4期	流感病毒感染	111	Inflexal V (Group A)	願鏇選獵鏇鬱選鑰簾願(鹹鑰糧膚願網獵構願糧) = 壓醖積遞鑰壓衊餘鹹壓願蓋獵鑰餘顧餘鏇艱襯 (襯選鑰鏇衊齋淵憲積醖, 鬱遞憲襯窪獵選襯遞選 ~ 願鏇願製範襯壓獵築膚) 更多	-	2011-12-19
				Inflexal V (Group B)	願鏇選獵鏇鬱選鑰簾願(鹹鑰糧膚願網獵構願糧) = 願鏇積遞遞選製膚窪鏇願蓋獵鑰餘顧餘鏇艱襯 (襯選鑰鏇衊齋淵憲積醖, 醖糧襯餘壓製築鬱鑰遞 ~ 夢壓鏇繭壓憲願簾網淵) 更多