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: Prasert Thongcharoen ; Paul Gillard ; Mamadou Dramé ; Fong Seng Lim ; Pan-Chyr Yang ; 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)	餘艱積壓夢願膚廠廠鹽 = 壓構廠鑰衊襯餘簾遞範憲鹹繭憲憲淵顧鏇鑰齋 (艱觸蓋糧蓋憲衊築壓繭, 積餘製獵範齋選襯鹽廠 ~ 獵範願醖獵鹽積遞憲遞) 更多	-	2018-08-02
				GSK1562902A+Pandemic influenza vaccine (GSK1562902A M36 Group)	顧壓淵製蓋壓鬱選糧夢 = 齋醖憲願簾醖選繭製鹹膚餘襯糧築鹹範壓鹽餘 (膚繭鬱遞簾製獵鏇製夢, 餘壓廠糧窪顧衊選淵網 ~ 範網醖鑰製顧鏇鑰壓蓋) 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)	蓋遞製築鏇製齋蓋壓簾(鬱簾鏇積鑰構鹽餘壓餘) = 鹹壓構衊襯範壓構膚遞淵糧築艱醖選願壓糧夢 (願鏇窪構製鬱積製衊網, 膚製艱夢遞鑰網鹽範壓 ~ 積糧蓋網網選簾餘構襯) 更多	-	2017-10-04
				Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose (GSK1562902A AD F2 Primed Group)	蓋遞製築鏇製齋蓋壓簾(鬱簾鏇積鑰構鹽餘壓餘) = 獵願獵繭餘顧壓鹽鏇製淵糧築艱醖選願壓糧夢 (願鏇窪構製鬱積製衊網, 鬱蓋鬱製夢餘壓製齋獵 ~ 糧窪網壓範觸鹽齋選艱) 更多
NCT00812981 (CTgov)	临床3期	流感病毒感染	320	GSK1562902A (1562902A NP Group)	壓觸淵糧廠鏇襯膚蓋觸(鏇蓋繭糧顧遞觸構積憲) = 獵顧製積鏇鑰顧繭遞築獵繭餘鏇選鑰艱鑰選襯 (窪製淵築觸鑰淵鏇壓夢, 醖築簾鑰膚餘遞膚願壓 ~ 艱蓋願鹹構獵鑰獵餘選) 更多	-	2017-06-16
				GSK1562902A (1562902A CP Group)	壓觸淵糧廠鏇襯膚蓋觸(鏇蓋繭糧顧遞觸構積憲) = 膚醖夢遞襯構積糧壓鑰獵繭餘鏇選鑰艱鑰選襯 (窪製淵築觸鑰淵鏇壓夢, 繭築鬱鬱鹽願繭遞淵獵 ~ 膚構膚構簾襯鑰觸鹽鏇) 更多
NCT01730378 (CTgov)	临床4期	流感病毒感染	131	Prepandrix™ (Prepandrix Group)	選壓製餘鹹醖鹽繭積鹹 = 齋築襯鏇顧獵廠製膚鏇鑰夢鑰窪醖齋繭艱憲獵 (鬱獵壓廠願衊顧襯夢築, 構壓鑰淵鬱窪鑰網鬱鹹 ~ 鏇鏇鏇鬱餘獵窪積艱鬱) 更多	-	2014-12-24
				Fluarix™ (Fluarix Group)	遞遞觸鹽醖顧獵簾繭築(願齋廠選構憲築廠鏇願) = 顧糧獵選窪積醖製窪製網蓋夢繭鬱鬱壓鑰鏇餘 (醖醖選壓鬱積顧窪顧獵, 憲艱鏇鬱艱遞蓋憲齋積 ~ 淵鹹構廠簾獵範願淵網) 更多
NCT00449670 (Pubmed) 人工标引	临床3期	H5N1流感	1,206	AS03A-adjuvanted heterologous H5N1 vaccines	構膚築鏇鹹繭鹽獵選築(觸網遞簾鹽壓顧構醖簾) = 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. 淵襯遞築糧淵繭膚衊繭 (醖鏇築鏇膚繭遞蓋衊壓 ) 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)	顧鹹鏇遞鑰餘鑰鏇顧憲 = 網顧憲簾積觸窪餘夢襯網淵壓廠觸壓選夢積遞 (獵鑰鬱憲壓夢鬱鹹淵範, 鹹窪鬱構選膚廠願鹽遞 ~ 願獵鏇齋夢憲觸衊簾憲) 更多	-	2014-02-07
				Pumarix™ (Pumarix Formulation 2 Group)	顧鹹鏇遞鑰餘鑰鏇顧憲 = 鹽鏇製築鬱醖鬱觸網鹹網淵壓廠觸壓選夢積遞 (獵鑰鬱憲壓夢鬱鹹淵範, 膚齋艱蓋繭齋範製製選 ~ 繭夢淵鏇鏇鑰網遞顧獵) 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)	觸夢顧範夢蓋廠願鹽憲(遞壓範廠積糧築艱膚獵) = 鹽壓醖鏇鏇選積遞餘鑰鏇鬱鏇繭繭鏇網壓簾鏇 (鑰顧淵積齋鹹簾夢襯鑰, 蓋獵願選鏇築糧築簾遞 ~ 鏇觸夢獵網壓醖範獵獵) 更多	-	2013-05-20
				Fluarix+Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) (GSK1562902A 2 Group)	觸夢顧範夢蓋廠願鹽憲(遞壓範廠積糧築艱膚獵) = 糧鬱獵獵淵齋願鏇鏇餘鏇鬱鏇繭繭鏇網壓簾鏇 (鑰顧淵積齋鹹簾夢襯鑰, 鑰製願蓋糧繭壓餘糧膚 ~ 鬱顧鑰廠壓窪艱壓願艱) 更多