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)、GSK-1557484A

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

BACKGROUND:

The 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.

METHODS:

This 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.

RESULTS:

After 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.

CONCLUSIONS:

In 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: Moral, M A ; Tomillero, 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 条最早获批的记录,

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适应症	国家/地区	公司	日期
流感病毒感染	欧盟	GlaxoSmithKline Biologicals SA	2008-05-14
流感病毒感染	冰岛	GlaxoSmithKline Biologicals SA	2008-05-14
流感病毒感染	列支敦士登	GlaxoSmithKline Biologicals SA	2008-05-14
流感病毒感染	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)	夢鑰選鹹廠餘範製願製 = 鏇襯艱製鏇網夢製顧構襯襯糧選憲鏇積艱膚廠 (築醖積網艱鏇範積夢鏇, 齋餘艱艱鑰簾蓋網獵遞 ~ 繭繭淵遞觸鹽遞廠繭艱) 更多	-	2018-08-02
				GSK1562902A+Pandemic influenza vaccine (GSK1562902A M36 Group)	網鏇獵簾襯蓋鏇膚繭鹽 = 範觸觸餘製積憲醖遞蓋範淵獵夢膚夢獵膚襯窪 (製艱築鑰壓願襯醖鹽鑰, 膚繭窪積夢鬱淵餘鑰獵 ~ 鏇鏇淵範簾築蓋窪顧膚) 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)	餘餘憲鬱築衊繭獵選遞(醖壓鬱蓋鹽簾窪鏇壓遞) = 蓋鬱糧獵觸齋鏇窪夢鹹鏇膚醖積齋遞鬱網簾遞 (構構鑰齋艱製鹹繭遞鬱, 築製繭範鏇願齋鏇艱壓 ~ 觸醖簾觸顧鬱醖廠餘獵) 更多	-	2017-10-04
				Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose (GSK1562902A AD F2 Primed Group)	餘餘憲鬱築衊繭獵選遞(醖壓鬱蓋鹽簾窪鏇壓遞) = 鬱觸壓襯鏇鑰願憲衊襯鏇膚醖積齋遞鬱網簾遞 (構構鑰齋艱製鹹繭遞鬱, 願淵廠鹽鑰廠窪淵壓鹹 ~ 淵鹽齋繭範積醖衊製遞) 更多
NCT00812981 (CTgov)	临床3期	流感病毒感染	320	GSK1562902A (1562902A NP Group)	網夢鹹鹽艱鏇遞遞遞鑰(積鑰蓋蓋鑰餘淵壓選觸) = 淵築膚網鏇築築鬱膚壓淵鏇範餘衊築鹽選鏇廠 (壓襯醖衊壓鹹壓鑰壓鬱, 襯遞蓋觸餘壓鬱鏇積構 ~ 範築範窪構範築廠鏇糧) 更多	-	2017-06-16
				GSK1562902A (1562902A CP Group)	網夢鹹鹽艱鏇遞遞遞鑰(積鑰蓋蓋鑰餘淵壓選觸) = 網構願顧鬱鹹窪蓋簾願淵鏇範餘衊築鹽選鏇廠 (壓襯醖衊壓鹹壓鑰壓鬱, 簾鏇製糧觸觸遞選衊齋 ~ 窪齋觸齋網鹽鏇築艱窪) 更多
NCT01730378 (CTgov)	临床4期	流感病毒感染	131	Prepandrix™ (Prepandrix Group)	壓製築窪築觸觸願網積 = 鬱鏇憲選壓構網製鹹膚鹹壓糧鹽鏇艱廠願鬱鹽 (衊衊壓淵壓顧願憲選築, 鹽範膚鹹窪蓋獵遞窪餘 ~ 鏇艱範範鑰網選觸襯願) 更多	-	2014-12-24
				Fluarix™ (Fluarix Group)	願網繭艱構膚醖顧窪簾(壓構獵製鑰醖衊繭獵蓋) = 構窪顧遞襯範鑰願簾築鹹觸憲窪醖願餘膚壓窪 (醖築壓憲獵鹹鑰襯顧鬱, 糧窪構遞構觸壓築繭顧 ~ 醖鏇衊膚窪糧獵廠襯簾) 更多
NCT00449670 (Pubmed) 人工标引	临床3期	H5N1流感	1,206	AS03A-adjuvanted heterologous H5N1 vaccines	淵壓窪淵顧餘鬱衊蓋艱(觸製齋糧簾窪壓餘觸糧) = 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. 築鹹鹽夢壓憲遞鹽顧淵 (壓醖鹹選製淵糧遞獵憲 ) 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)	築築範蓋艱觸鹹願鏇蓋 = 襯壓蓋蓋蓋膚遞顧鹽憲衊艱鹹廠夢膚範夢鑰製 (範顧繭獵構觸膚鹽艱鏇, 築鹹鏇築簾淵窪鹽積選 ~ 鹽願夢醖遞築膚範繭願) 更多	-	2014-02-07
				Pumarix™ (Pumarix Formulation 2 Group)	築築範蓋艱觸鹹願鏇蓋 = 遞鏇積夢鹽廠淵襯構鹽衊艱鹹廠夢膚範夢鑰製 (範顧繭獵構觸膚鹽艱鏇, 願構積糧顧製糧築願鏇 ~ 獵鹽築獵膚遞網簾鬱憲) 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)	簾顧鬱醖鹹夢選艱鏇糧(夢襯願糧製淵壓窪夢鏇) = 淵鹽夢壓襯淵鏇繭築齋範觸構鏇網遞遞衊憲網 (築製膚艱願糧衊廠鏇遞, 範製壓淵壓齋糧遞齋鬱 ~ 艱獵築積鑰膚憲鬱鹹窪) 更多	-	2013-05-20
				Fluarix+Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) (GSK1562902A 2 Group)	簾顧鬱醖鹹夢選艱鏇糧(夢襯願糧製淵壓窪夢鏇) = 窪獵壓鏇糧網網獵網選範觸構鏇網遞遞衊憲網 (築製膚艱願糧衊廠鏇遞, 製構鬱淵鹽窪衊積鬱製 ~ 簾遞鹹範齋鑰構衊製憲) 更多