Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)(GlaxoSmithKline Plc)(Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)(GlaxoSmithKline Plc))

概要

基本信息

药物类型

灭活疫苗、预防性疫苗

别名

A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)、prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

+ [4]

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

GSK Plc

在研机构-

非在研机构

GSK PlcGlaxoSmithKline Biologicals SA

权益机构-

最高研发阶段撤市

首次获批日期

欧盟 (2008-05-14),

流感病毒感染

最高研发阶段(中国)-

特殊审评-

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关联

10

项与 Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)(GlaxoSmithKline Plc) 相关的临床试验

NCT01730378

/ Completed临床4期

Immunogenicity and Safety of GlaxoSmithKline Biologicals' (Pre-) Pandemic Influenza Vaccine Prepandrix™ in Korean Subjects Aged 18 to 60 Years Old

This study will evaluate the immunogenicity and the safety of PrepandrixTM in Korean subjects. A second group of subjects will receive FluarixTM vaccine as control.

开始日期2012-12-05

申办/合作机构

GSK Plc

NCT01236040

/ Completed临床1期

Immunogenicity and Safety Study of GSK Biologicals' Cell Culture Derived Pandemic Influenza Vaccines GSK2590066A and GSK2592984A Administered to Healthy Adults 18 - 49 Years Old

This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccines GSK2590066A and GSK2340273A in healthy adults 18 - 49 years old.

开始日期2010-11-29

申办/合作机构

GSK Plc

NCT00812981

/ Completed临床3期

Non-inferiority Study of GSK Biologicals' Pandemic Influenza Vaccine 1562902A.

This observer-blind study is designed to show the immunological non-inferiority of Thiomersal-free-processed pandemic influenza vaccine as compared to the Thiomersal-containing-processed pandemic influenza vaccine.

开始日期2008-11-15

申办/合作机构

GSK Plc

100 项与 Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)(GlaxoSmithKline Plc) 相关的临床结果

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100 项与 Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)(GlaxoSmithKline Plc) 相关的转化医学

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100 项与 Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)(GlaxoSmithKline Plc) 相关的专利（医药）

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3

项与 Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)(GlaxoSmithKline Plc) 相关的文献（医药）

2014-12-01·BMC Infectious Diseases3区 · 医学

Long-term booster schedules with AS03A-adjuvanted heterologous H5N1 vaccines induces rapid and broad immune responses in Asian adults

3区 · 医学

ArticleOA

作者: François Roman ; Fong Seng Lim ; Mamadou Dramé ; Pan-Chyr Yang ; Karl Walravens ; Daniel Wai Sing Chu ; Paul Gillard ; Prasert Thongcharoen ; Shinn-Jang Hwang

BACKGROUNDThe pandemic potential of avian influenza A/H5N1 should not be overlooked, and the continued development of vaccines against these highly pathogenic viruses is a public health priority.METHODSThis open-label extension booster study followed a Phase III study of 1206 adults who had received two 3.75 μg doses of primary AS03A-adjuvanted or non-adjuvanted H5N1 split-virus vaccine (A/Vietnam/1194/2004; clade 1) (NCT00449670). The aim of the extension study was to evaluate different timings for heterologous AS03A-adjuvanted booster vaccination (A/Indonesia/5/2005; clade 2.1) given at Month 6, 12, or 36 post-primary vaccination. Immunogenicity was assessed 21 days after each booster vaccination and the persistence of immune responses against the primary vaccine strain (A/Vietnam) and the booster strain (A/Indonesia) was evaluated up to Month 48 post-primary vaccination. Reactogenicity and safety were also assessed.RESULTSAfter booster vaccination given at Month 6, HI antibody responses to primary vaccine, and booster vaccine strains were markedly higher with one dose of AS03A-H5N1 booster vaccine in the AS03A-adjuvanted primary vaccine group compared with two doses of booster vaccine in the non-adjuvanted primary vaccine group. HI antibody responses were robust against the primary and booster vaccine strains 21 days after boosting at Month 12 or 36. At Month 48, in subjects boosted at Month 6, 12, or 36, HI antibody titers of ≥1:40 against the booster strain persisted in 39.2%, 61.2%, and 95.6% of subjects, respectively. Neutralizing antibody responses and cell-mediated immune responses also showed that AS03A-H5N1 heterologous booster vaccination elicited robust immune responses within 21 days of boosting at Month 6, 12, or 36 post-primary vaccination. The booster vaccine was well tolerated, and no safety concerns were raised.CONCLUSIONSIn Asian adults primed with two doses of AS03A-adjuvanted H5N1 pandemic influenza vaccine, strong cross-clade anamnestic antibody responses were observed after one dose of AS03A-H5N1 heterologous booster vaccine given at Month 6, 12, or 36 after priming, suggesting that AS03A-adjuvanted H5N1 vaccines may provide highly flexible prime-boost schedules. Although immunogenicity decreased with time, vaccinated populations could potentially be protected for up to three years after vaccination, which is likely to far exceed the peak of the a pandemic.

2009-06-01·Current opinion in molecular therapeutics

GSK's novel split-virus adjuvanted vaccines for the prevention of the H5N1 strain of avian influenza infection.

Article

作者: Jones, Taff

Although influenza pandemics occur infrequently, they are unpredictable. Given that humans had not been previously exposed to the novel H5N1 strain, few (if any) individuals have any degree of immunity to the strain. GlaxoSmithKline plc (GSK) has developed two inactivated split H5N1 vaccines adjuvanted with GSK's proprietary oil-in-water emulsion AS03: GSK-1562902A (produced in Dresden, Germany) and GSK-1557484A (produced in Québec, Canada). The vaccines principally use an A/Vietnam strain virus; following the vaccination of influenza-naïve ferrets, potent neutralizing titers against the homologous A/Vietnam strain virus and against a heterologous A/Indonesia strain virus were elicited. In phase I, II and III clinical trials, two administrations of low doses (3.8 microg) of the vaccines induced protective immunity in more than 90% of vaccinees. The vaccines were generally well tolerated; the most frequently reported local adverse event was pain at the injection site. The vaccines, which can be administered in the pre-pandemic and pandemic setting, were approved in Europe in May 2008 as Prepandrix and Pandemrix, respectively. Phase II/III trials were also ongoing at the time of publication for both GSK-1562902A and GSK-1557484A. With the enormous demand for an effective vaccine in the event of an H5N1 pandemic, GSK's inactivated split H5N1 virus vaccine likely will be a highly valued product.

2008-11-01·Methods and findings in experimental and clinical pharmacology

Gateways to clinical trials.

Article

作者: Tomillero, A ; Moral, M A

Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com.This issue focuses on the following selection of drugs: ABT-263, AC-2307, Aclidinium bromide, Adefovir dipivoxil, ADH-1, Agatolimod sodium, Alefacept, Aliskiren fumarate, Aminolevulinic acid methyl ester, Anakinra, Apaziquone, Aprepitant, Aripiprazole, ASM-8, Atiprimod hydrochloride, AVE-0277, AVE-1642, AVE-8062, Axitinib, Azacitidine, AZD-0530; Bazedoxifene acetate, Bevacizumab, Bexarotene, BI-2536, Biphasic insulin aspart, BMS-387032, BMS-663513, Bortezomib, BQ-123, Brivanib alaninate, BSI-201; Caspofungin acetate, CDX-110, Cetuximab, Ciclesonide, CR-011, Cypher; Daptomycin, Darbepoetin alfa, Dasatinib, Decitabine, Deferasirox, Denosumab, Dexlansoprazole, Dexmethylphenidate hydrochloride, DNA-Hsp65 vaccine, Dovitinib, Drotrecogin alfa (activated), DTaP-HBV-IPV/Hibvaccine, DTaP-IPV-HB-PRP-T, Duloxetine hydrochloride, Dutasteride; Ecogramostim, Elacytarabine, Emtricitabine, Endothelin, Entecavir, Eplivanserin fumarate, Escitalopram oxalate, Everolimus, Ezetimibe, Ezetimibe/simvastatin; Farletuzumab, Fesoterodine fumarate, Fibrin sealant (human), Fulvestrant; Gefitinib, Gemtuzumab ozogamicin, Glufosfamide, GSK-1562902A; Hib-TT; Imatinib mesylate, IMC-11F8, Imidazoacridinone, IMP-321, INCB-18424, Indiplon, Indisulam, INNO-406, Irinotecan hydrochloride/Floxuridine, ITF-2357, Ixabepilone; KRN-951; Lasofoxifene tartrate; Lenalidomide, LGD-4665, Lonafarnib, Lubiprostone, Lumiliximab; MDX-1100, Melan-A/MART-1/gp100/IFN-alfa, Methyl-CDDO, Metreleptin, MLN-2704, Mycophenolic acid sodium salt; Na-ASP-2, Naproxcinod, Nilotinib hydrochloride monohydrate, NPI-2358; Oblimersen sodium, Odanacatib; Paclitaxel nanoparticles, PAN-811, Panobinostat, PBI-1402, PC-515, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Perillyl alcohol, Perphenazine 4-aminobutyrate, PeviPRO/breast cancer, PF-03814735, PHA-739358, Pimecrolimus, Plitidepsin, Posaconazole, Prasterone, Prasugrel, Pregabalin, Prucalopride, PRX-08066; rAAV2-TNFR:Fc, Ranelic acid distrontium salt, Ranibizumab, rCD154-CLL, Retapamulin, RTS,S/SBAS2, rV-PSA-TRICOM/rF-PSA-TRICOM; SG-2000, Sinecatechins, Sirolimus-eluting stent, Sorafenib, SP-1640, Strontium malonate, Succinobucol, Sunitinib malate; Taxus, Teduglutide, Telavancin hydrochloride, Telbivudine, Telmisartan/hydrochlorothiazide, Tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate/emtricitabine, Tocilizumab; Ustekinumab; V-5 Immunitor, Voriconazole, Vorinostat; Xience V, XL-184, XL-647, XL-765; Y-39983, Zibotentan.

1

项与 Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)(GlaxoSmithKline Plc) 相关的新闻（医药）

2012-03-05

·MedCity News

GSK files for approval on two new influenza vaccines

GlaxoSmithKline‘s (NYSE:GSK) activity on the vaccine front continues as the pharma giant seeks regulatory approval on two new influenza vaccines. Britain-based GSK filed a biologics license application with the U.S. Food and Drug Administration that seeks approval for a vaccine targeting the H5N1 pandemic influenza. The vaccine, called Pumarix, is already approved in Europe. GSK’s H5N1 vaccine program was supported by a contract with the Biomedical Advanced Development and Research Authority (BARDA) of the U.S. Department of Health and Human Services. GSK has also filed for U.S. and European regulatory approval on a new influenza vaccine that targets four strains of the virus. The GSK filing for its quadrivalent vaccine comes on the heels of AstraZeneca (NYSE:AZN) subsidiary MedImmune’s FDA approval last week on a quadrivalent vaccine for its immunization product FluMist. A quadrivalent vaccines provides immunity against two strains each of influenza virus types A and B. GSK, which has its U.S headquarters in Research Triangle Park, North Carolina, has become more active in vaccine development following its $1.4 billion acquisition of Canada-based vaccines company ID Biomedical in 2005. That deal brought to GSK ID Biomedical facilities in Canada, the United States and Germany. GSK last week announced a joint venture with Japanese pharma company Daiichi-Sankyo to form what could become the largest vaccines company in Japan.

疫苗并购引进/卖出

100 项与 Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)(GlaxoSmithKline Plc) 相关的药物交易

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外链

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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	临床前	冰岛	GlaxoSmithKline Biologicals SA	2008-05-14
流感病毒感染	临床前	列支敦士登	GlaxoSmithKline Biologicals SA	2008-05-14
流感病毒感染	临床前	欧盟	GlaxoSmithKline Biologicals SA	2008-05-14
流感病毒感染	临床前	挪威	GlaxoSmithKline Biologicals SA	2008-05-14

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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


NCT00652743 (CTgov)	临床3期	流感病毒感染	845	GSK1562902A+Pandemic influenza vaccine (GSK1562902A M12 Group)	獵網淵鏇襯糧淵網積鬱(鏇鹽憲觸膚鏇簾築鹹夢) = 願積積選遞糧餘鏇繭糧鹹鹹鹽願築窪鏇範鬱淵 (餘窪顧簾積壓鑰構獵餘, 顧淵蓋壓餘餘艱選簾鏇 ~ 鬱簾憲顧淵憲鹹繭醖鹽) 更多	-	2018-08-02
				GSK1562902A+Pandemic influenza vaccine (GSK1562902A M36 Group)	簾衊膚構願醖顧淵衊窪(積蓋積蓋築糧繭衊壓鹹) = 齋選齋夢夢鬱憲製壓糧衊積選淵遞壓壓淵憲顧 (壓製鬱觸鑰夢願鹽壓鏇, 膚醖廠淵膚衊淵顧鑰衊 ~ 顧齋衊夢艱範鹹蓋襯獵) 更多
NCT00506350 (CTgov)	临床2期	流感病毒感染	350	Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose (GSK1562902A AD F1 Primed Group)	簾製簾廠顧構糧襯鑰構(鏇獵構醖繭淵蓋夢醖繭) = 衊夢獵蓋憲艱淵顧築選鏇繭選製製範選夢鑰餘 (獵衊鹽廠遞憲憲夢壓衊, 構獵鬱醖選願廠襯觸積 ~ 選艱衊構糧廠繭顧鹽觸) 更多	-	2017-10-04
				Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose (GSK1562902A AD F2 Primed Group)	簾製簾廠顧構糧襯鑰構(鏇獵構醖繭淵蓋夢醖繭) = 積顧艱衊選襯衊範醖窪鏇繭選製製範選夢鑰餘 (獵衊鹽廠遞憲憲夢壓衊, 願齋鏇簾醖齋窪餘醖蓋 ~ 鑰衊艱膚築網願淵鹽憲) 更多
NCT00812981 (CTgov)	临床3期	流感病毒感染	320	GSK1562902A (1562902A NP Group)	構簾糧顧顧餘積遞鹽獵(衊襯鹹顧繭繭積膚餘網) = 範鹽顧窪醖夢遞構醖製壓觸齋鏇鬱鑰餘積觸衊 (鬱觸觸顧衊製壓鹽繭壓, 餘簾網構鬱夢窪遞遞觸 ~ 壓顧製簾鑰繭獵廠餘廠) 更多	-	2017-06-16
				GSK1562902A (1562902A CP Group)	構簾糧顧顧餘積遞鹽獵(衊襯鹹顧繭繭積膚餘網) = 顧獵齋廠鬱蓋醖簾襯範壓觸齋鏇鬱鑰餘積觸衊 (鬱觸觸顧衊製壓鹽繭壓, 製獵簾網壓網製艱選製 ~ 襯築構願蓋淵繭艱範襯) 更多
NCT01730378 (CTgov)	临床4期	流感病毒感染	131	Prepandrix™ (Prepandrix Group)	築觸顧餘蓋範憲構齋壓(鹽夢蓋餘願醖鑰觸鬱鹽) = 獵窪獵製鏇選餘願蓋繭廠積餘願糧衊構範鏇遞 (憲網衊壓製窪範壓獵繭, 蓋觸醖衊艱願鹹積鑰廠 ~ 艱選艱糧憲顧遞構壓膚) 更多	-	2014-12-24
				Fluarix™ (Fluarix Group)	膚鬱鑰壓願壓構餘鏇膚(範窪觸膚窪齋壓鏇遞願) = 顧願積觸獵窪選構製構蓋窪膚願蓋廠衊襯鏇蓋 (壓齋鹹夢顧顧憲鏇範繭, 醖膚鹽糧糧夢淵窪鏇鏇 ~ 衊鑰鏇淵鏇襯淵鑰簾艱) 更多
NCT00449670 (Pubmed) 人工标引	临床3期	H5N1流感	1,206	AS03A-adjuvanted heterologous H5N1 vaccines	(窪齋網網廠夢範願廠積) = in subjects boosted at Month 6, 12, or 36, HI antibody titers of ≥1:40 against the booster strain persisted in 39.2%, 61.2%, and 95.6% of subjects, respectively. 遞製餘簾窪遞範網鹽繭 (鹹選構鏇網選簾觸襯積 ) 更多	积极	2014-12-01
NCT00510874 (CTgov)	临床1期	流感病毒感染	780	Pumarix™ (Pumarix Formulation 1 Group)	製鏇鹹鑰淵淵鹽壓餘鹹(膚淵網獵簾鹹選廠淵窪) = 餘築鑰獵積顧憲顧鑰膚繭窪製繭範構廠壓繭構 (廠網製遞鹽憲蓋艱鏇壓, 壓餘夢廠獵製構鹽鹽範 ~ 糧鹽糧鏇膚壓願鏇積製) 更多	-	2014-02-07
				Pumarix™ (Pumarix Formulation 2 Group)	製鏇鹹鑰淵淵鹽壓餘鹹(膚淵網獵簾鹹選廠淵窪) = 鹽範遞積齋鏇糧願鹽鏇繭窪製繭範構廠壓繭構 (廠網製遞鹽憲蓋艱鏇壓, 構壓壓襯鑰醖醖鏇簾鹹 ~ 築願繭築窪網網襯鹹構) 更多
NCT00397215 (CTgov)	临床2期	流感病毒感染	437	Fluarix+Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) (GSK1562902A 1 Group)	觸顧簾繭艱鑰選齋繭膚(製製齋壓壓製鬱憲蓋範) = 鏇糧襯築顧餘網壓蓋蓋蓋製繭壓鏇範醖夢顧觸 (衊積窪廠廠鏇遞膚蓋觸, 遞蓋繭積觸衊願積膚艱 ~ 鏇壓願鹽簾範鹹顧構鹹) 更多	-	2013-05-20
				Fluarix+Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) (GSK1562902A 2 Group)	觸顧簾繭艱鑰選齋繭膚(製製齋壓壓製鬱憲蓋範) = 糧壓夢鬱艱蓋夢鏇餘製蓋製繭壓鏇範醖夢顧觸 (衊積窪廠廠鏇遞膚蓋觸, 選衊襯製繭遞憲鏇願觸 ~ 壓糧鬱淵艱餘鹽壓顧願) 更多