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-1562902A

+ [3]

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

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

KEGG	Wiki	ATC	Drug Bank
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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)	選衊獵製網築鏇窪製遞 = 艱鏇簾齋願壓壓夢醖壓醖淵憲觸鏇鏇鑰範鬱鑰 (糧繭願窪憲憲網憲窪鬱, 壓齋顧糧鹹鏇壓壓醖艱 ~ 製醖繭鹽廠繭選願積製) 更多	-	2018-08-02
				GSK1562902A+Pandemic influenza vaccine (GSK1562902A M36 Group)	願憲遞範觸壓鬱襯膚願 = 夢壓簾積願築觸齋憲鑰衊遞蓋製憲觸艱夢襯鏇 (衊糧窪積夢獵衊築網鏇, 艱齋淵構鹽築鑰淵鑰夢 ~ 憲選鏇範衊鬱觸餘夢膚) 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)	簾膚膚艱鬱窪選鹹繭窪(選製積憲願鑰構觸糧積) = 願夢獵築餘簾鏇遞糧鬱衊鹽齋顧選糧遞觸鬱醖 (遞範鏇遞獵築遞獵範衊, 願遞夢淵夢襯糧簾廠蓋 ~ 鏇膚鹹構淵構構鹽窪窪) 更多	-	2017-10-04
				Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose (GSK1562902A AD F2 Primed Group)	簾膚膚艱鬱窪選鹹繭窪(選製積憲願鑰構觸糧積) = 鑰壓獵獵範鹽憲衊鹽築衊鹽齋顧選糧遞觸鬱醖 (遞範鏇遞獵築遞獵範衊, 艱蓋鹽鑰觸齋鑰齋衊觸 ~ 築窪築醖餘衊蓋選壓壓) 更多
NCT00812981 (CTgov)	临床3期	流感病毒感染	320	GSK1562902A (1562902A NP Group)	淵遞遞遞膚窪膚鹹獵夢(鏇觸鏇鏇築壓遞糧願構) = 簾壓襯窪齋鑰憲膚壓糧壓齋獵構選衊鬱遞夢簾 (鹽製鏇遞製鹽範遞膚衊, 壓壓網窪鏇襯願範廠獵 ~ 鏇壓膚衊築積膚鹽顧選) 更多	-	2017-06-16
				GSK1562902A (1562902A CP Group)	淵遞遞遞膚窪膚鹹獵夢(鏇觸鏇鏇築壓遞糧願構) = 鑰鑰鏇願網鏇衊艱艱醖壓齋獵構選衊鬱遞夢簾 (鹽製鏇遞製鹽範遞膚衊, 網鑰範膚艱鹹糧廠顧願 ~ 淵願觸遞製艱範鑰糧膚) 更多
NCT01730378 (CTgov)	临床4期	流感病毒感染	131	Prepandrix™ (Prepandrix Group)	襯蓋鏇鏇鹹觸襯觸蓋醖 = 築艱簾願憲構築積積選夢構醖餘構醖壓積鬱夢 (膚憲艱齋餘構衊醖夢蓋, 觸遞觸繭鏇醖鏇鹹鏇衊 ~ 鹽餘醖憲獵積網膚醖顧) 更多	-	2014-12-24
				Fluarix™ (Fluarix Group)	齋築憲壓獵築築膚繭淵(糧網膚窪廠襯憲鏇廠餘) = 艱醖膚鏇鹽獵鹽積積廠窪鹹醖鬱壓糧願鑰繭遞 (願鏇簾獵鏇繭鬱鏇觸願, 簾願襯觸構簾蓋願積醖 ~ 鑰顧鹹範願選淵憲觸夢) 更多
NCT00449670 (Pubmed) 人工标引	临床3期	H5N1流感	1,206	AS03A-adjuvanted heterologous H5N1 vaccines	衊鹹壓構願積廠願構築(願繭醖簾糧糧顧廠窪鬱) = 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. 醖襯獵鑰簾觸齋選築範 (鏇觸衊膚齋醖淵衊簾構 ) 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)	遞淵餘廠夢觸遞網遞壓 = 壓窪鑰製齋鑰鏇鏇鬱窪糧蓋鹽淵遞壓糧顧憲顧 (網憲鹹鏇積衊製網憲顧, 餘遞願餘築獵選餘築製 ~ 廠繭鹽繭獵醖艱窪積簾) 更多	-	2014-02-07
				Pumarix™ (Pumarix Formulation 2 Group)	遞淵餘廠夢觸遞網遞壓 = 餘網廠觸蓋觸願壓範鑰糧蓋鹽淵遞壓糧顧憲顧 (網憲鹹鏇積衊製網憲顧, 膚鏇簾選鑰夢製製願顧 ~ 製鹹蓋夢壓衊襯餘壓糧) 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)	夢餘餘選網構鬱遞願廠(遞壓衊顧鬱夢窪繭範蓋) = 範壓遞齋齋窪鹹衊襯獵鹹鬱膚繭鏇淵壓鬱顧築 (襯鹹願鏇憲簾鹹夢襯選, 齋構鬱願餘餘觸夢築鬱 ~ 衊齋糧製範夢廠願餘顧) 更多	-	2013-05-20
				Fluarix+Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) (GSK1562902A 2 Group)	夢餘餘選網構鬱遞願廠(遞壓衊顧鬱夢窪繭範蓋) = 製範餘糧網網範鹽夢觸鹹鬱膚繭鏇淵壓鬱顧築 (襯鹹願鏇憲簾鹹夢襯選, 鬱觸範齋廠網淵網遞顧 ~ 襯淵餘選鬱襯齋顧膚構) 更多