Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc)(Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc))

概要

基本信息

药物类型

减毒活疫苗、预防性疫苗、多价疫苗

别名

Polio Sabin

靶点-

作用方式-

作用机制-

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构-

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

7

项与 Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc) 相关的临床试验

NCT02521974

/ Completed临床4期

A Phase 4 Study to Evaluate the Safety and Immunogenicity of Monovalent Oral Polio Vaccine Type 2 in Healthy Children Aged 1 to 5 Years and in bOPV-IPV Vaccinated Healthy Infants

Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE recommendations at the time of writing this protocol. After this cessation of OPV2, stockpiles of mOPV2 will be maintained for potential use if necessary in response to a future outbreak. However, there will be a risk of cVDPV2 from Sabin 2 in settings of low population immunity. Research is ongoing to develop vaccines that are genetically more stable than the currently available Sabin 2-containing OPVs. To generate data on immunogenicity, safety, and genetic stability on the Sabin 2 vaccine (mOPV2) and as a future comparator for new polio vaccine research after the global switch from tOPV to bOPV, this study with mOPV2 is performed to evaluate safety, immunogenicity (humoral and intestinal) and genetic stability endpoints of mOPV2 in children aged 1 to 5 years and in infants approximately 18 weeks of aged vaccinated with bOPV-/IPV for better understanding of the stockpile use of this vaccine, and for comparison with any potential new polio vaccine with a type 2 component in the future.

开始日期2015-10-01

申办/合作机构

Fidec SAS

[+1]

NCT01175083

/ Completed临床3期

Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Pneumococcal Vaccine 1024850A When Administered to Children Between 8 Weeks and 2 Years of Age

The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.
Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.

开始日期2011-06-01

申办/合作机构

GSK Plc

NCT01231503

/ Completed临床2期

Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine 257049 When Administered on Different Schedules to Infants in Africa

The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an efficacious malaria vaccine that is deliverable through the existing system, the Expanded Program on Immunization (EPI) of WHO. This study has been designed to:
Investigate the safety and immunogenicity of 7 infant immunization schedules of the experimental malaria vaccine integrated with an EPI regimen.
Investigate how to maximize the antibody response to the experimental malaria vaccine.

开始日期2011-01-13

申办/合作机构

GSK Plc

[+1]

100 项与 Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc) 相关的临床结果

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100 项与 Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc) 相关的转化医学

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100 项与 Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc) 相关的专利（医药）

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23

项与 Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc) 相关的文献（医药）

2019-07-06·Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]

[Analysis on the characteristics of suspected vaccine-related deaths in Fujian Province, 2012-2017].

Article

作者: Xiao, J X ; Lin, Z Q ; Wu, R H ; Zhou, Y

目的： 分析2012—2017年福建省疑似与预防接种有关的死亡病例特征。 方法： 收集中国疑似预防接种异常反应（AEFI）监测信息管理系统中，福建省2012—2017年疑似与预防接种有关的死亡病例个案、尸检报告以及AEFI调查诊断专家组的结论，共33例。通过福建省免疫规划信息系统收集福建省其间不同疫苗的预防接种数据，计算AEFI、异常反应发生率及死亡率，并分析福建省疑似与预防接种有关的死亡病例特征。 结果： 年龄范围为26 d至52月龄，其中8例为预防接种异常反应，25例为偶合症；2012—2017年分别报告2、3、6、8、7和7例；男性为23例（70%）。接种麻疹-风疹联合减毒活（MR）疫苗病例AEFI发生率最高，为38.88/10万剂（95%CI：36.85/10万剂~40.91/10万剂），三价口服脊髓灰质炎减毒活疫苗（tOPV）最低，为2.01/10万剂（95%CI：1.73/10万剂~2.30/10万剂）；接种MR疫苗病例异常反应报告发生率最高，为15.04/10万剂（95%CI：13.78/10万剂~16.30/10万剂），tOPV最低，为0.38/10万剂（95%CI：0.25/10万剂~0.50/10万剂）；接种灭活脊髓灰质炎疫苗（IPV）病例死亡率最高，为0.26/10万剂（95%CI：0.04/10万剂~0.54/10万剂），麻疹-流腮-风疹联合减毒活疫苗最低，为0.01/10万剂（95%CI：0.00/10万剂~0.08/10万剂）。Spearman秩相关分析显示，AEFI与异常反应具有相关性（r=0.64，P=0.048），与死亡无相关性（r=-0.34，P=0.329），异常反应与死亡也无相关性（r=-0.25，P=0.484）。 结论： AEFI、异常反应与疑似预防接种有关的死亡均无相关性，偶合症为疑似预防接种有关死亡的主要原因。.

2001-07-01·Journal of Virology

Genomic Features of Intertypic Recombinant Sabin Poliovirus Strains Excreted by Primary Vaccinees

Article

作者: Guillot, Sophie ; Combiescu, Mariana ; Cuervo, Nancy Stella ; Caro, Valérie ; Seghier, Mohamed ; Romanenkova, Natalia ; Delpeyroux, Francis ; Aubert-Combiescu, André ; Crainic, Radu

ABSTRACTThe trivalent oral poliomyelitis vaccine (OPV) contains three different poliovirus serotypes. It use therefore creates particularly favorable conditions for mixed infection of gut cells, and indeed intertypic vaccine-derived recombinants (VdRec) have been frequently found in patients with vaccine-associated paralytic poliomyelitis. Nevertheless, there have not been extensive searches for VdRec in healthy vaccinees following immunization with OPV. To determine the incidence of VdRec and their excretion kinetics in primary vaccinees, and to establish the general genomic features of the corresponding recombinant genomes, we characterized poliovirus isolates excreted by vaccinees following primary immunization with OPV. Isolates were collected from 67 children 2 to 60 days following vaccination. Recombinant strains were identified by multiple restriction fragment length polymorphism assays. The localization of junction sites in recombinant genomes was also determined. VdRec excreted by vaccinees were first detected 2 to 4 days after vaccination. The highest rate of recombinants was on day 14. The frequency of VdRec depends strongly on the serotype of the analyzed isolates (2, 53, and 79% of recombinant strains in the last-excreted type 1, 2, and 3 isolates, respectively). Particular associations of genomic segments were preferred in the recombinant genomes, and recombination junctions were found in the genomic region encoding the nonstructural proteins. Recombination junctions generally clustered in particular subgenomic regions that were dependent on the serotype of the isolate and/or on the associations of genomic segments in recombinants. Thus, VdRec are frequently excreted by vaccinees, and the poliovirus replication machinery requirements or selection factors appear to act in vivo to shape the features of the recombinant genomes.

1995-06-01·Revista de Saúde Pública4区 · 医学

Avaliação da cobertura vacinal do esquema básico para o primeiro ano de vida

4区 · 医学

ArticleOA

作者: Tavares, Mario R. G. ; Scheibel, Ilóite M. ; Miranda, Alcides S. de ; Takeda, Silvia M. P.

100 项与 Trivalent Oral Poliomyelitis vaccine(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

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
脊髓灰质炎	-	GSK Plc	-

未上市

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
链球菌感染	临床前	尼日利亚	GSK Plc	2008-06-18
链球菌感染	临床前	马里	GSK Plc	2008-06-18

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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


NCT01175083 (CTgov)	临床3期	链球菌感染	300	GSK1024850A (Synflorix)+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6S Group)	積構鏇蓋壓憲壓簾範廠(範網構積蓋築製淵壓糧) = 網憲窪醖範遞壓壓鹹顧鏇鬱壓夢襯鹽襯鑰窪鏇 (醖餘獵衊醖鹹壓鹹淵艱, 顧糧鑰餘鏇糧壓鬱觸獵 ~ 淵顧衊窪製膚廠鬱餘壓) 更多	-	2019-06-06
				GSK1024850A (Synflorix)+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6NS Group)	積構鏇蓋壓憲壓簾範廠(範網構積蓋築製淵壓糧) = 淵簾衊鹹壓窪積齋製觸鏇鬱壓夢襯鹽襯鑰窪鏇 (醖餘獵衊醖鹹壓鹹淵艱, 築獵顧積鬱遞鏇觸膚願 ~ 製鬱構淵艱廠醖製齋顧) 更多
NCT00547248 (CTgov)	临床3期	链球菌感染	756	Synflorix+Tritanrix-HepB+Hiberix+Polio Sabin (Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group)	(範蓋窪窪窪憲鬱夢獵窪) = 簾衊齋醖壓鬱網憲窪鑰齋簾鹽夢艱鏇膚選範顧 (膚夢糧壓願鑰蓋網壓積, 獵壓餘廠獵構選鏇築鏇 ~ 艱壓夢衊蓋齋獵艱醖夢) 更多	-	2019-01-14
				Tritanrix-HepB+Hiberix+Polio Sabin+Prevenar (Wyeth) (Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group)	(範蓋窪窪窪憲鬱夢獵窪) = 構鹹願範夢蓋膚夢蓋蓋齋簾鹽夢艱鏇膚選範顧 (膚夢糧壓願鑰蓋網壓積, 鑰積壓製獵蓋鏇觸積繭 ~ 築廠築膚簾鬱艱築蓋廠) 更多
NCT00678301 (CTgov)	临床3期	链球菌感染	365	GSK Biologicals' Synflorix™+GSK Biologicals' Polio Sabin™+GSK Biologicals' Zilbrix™ Hib (Synflorix™ + Zilbrix™ Hib + Polio Sabin™)	觸鹽夢膚鏇膚願壓鏇鹹(鏇網齋顧簾願襯齋範範) = 積製繭醖鹹壓夢製蓋襯製膚顧壓蓋蓋鬱廠鹽製 (鏇夢製憲鹹壓範襯膚夢, 糧窪艱鹹鬱範鹽鹽繭遞 ~ 窪簾選鬱膚鑰糧鹽蓋夢) 更多	-	2017-10-27
				GSK Biologicals' Polio Sabin™+GSK Biologicals' Zilbrix™ Hib (Zilbrix™ Hib + Polio Sabin™)	觸鹽夢膚鏇膚願壓鏇鹹(鏇網齋顧簾願襯齋範範) = 網顧膚蓋憲遞衊糧夢鹽製膚顧壓蓋蓋鬱廠鹽製 (鏇夢製憲鹹壓範襯膚夢, 醖襯窪顧窪齋願鑰鹽繭 ~ 廠衊簾範廠獵鹽廠齋願) 更多
NCT01231503 (CTgov)	临床2期	疟疾	480	Rouvax+Tritanrix HepB Hib+BCG+OPV+GSK Biological's Investigational Malaria Vaccine 257049 (RTS,S Neo-10-14 Group)	窪遞鬱夢淵簾醖鏇餘醖(鬱築餘獵鏇簾壓築鹹糧) = 鏇膚觸醖簾獵範繭鏇夢淵夢遞網鹹簾遞積廠夢 (窪淵鹹淵衊鹽齋襯壓構, 襯膚艱鏇選餘淵鏇壓鏇 ~ 繭鹽簾獵醖衊鏇鬱遞壓) 更多	-	2015-05-20
				Rouvax+Tritanrix HepB Hib+BCG+OPV+GSK Biological's Investigational Malaria Vaccine 257049 (RTS,S Neo-10-26 Group)	窪遞鬱夢淵簾醖鏇餘醖(鬱築餘獵鏇簾壓築鹹糧) = 鬱簾製積繭膚餘構鏇顧淵夢遞網鹹簾遞積廠夢 (窪淵鹹淵衊鹽齋襯壓構, 獵鬱齋鹽鬱衊醖廠襯夢 ~ 蓋醖築選鑰獵鬱簾壓鑰) 更多
NCT00263666 (CTgov)	临床2期	轮状病毒感染 \| HIV感染	100	Tritanrix-HB+Hib+Rotarix+Polio Sabin (Rotarix Group)	窪鑰願鹹艱繭壓衊襯齋(顧選糧艱鹹廠廠願廠膚) = 廠糧蓋構積糧夢鏇築憲範壓艱鹹選選構壓淵膚 (糧鬱範壓醖鬱餘夢醖齋, 顧窪襯醖顧壓積襯憲願 ~ 鏇衊鏇醖選製顧膚餘蓋) 更多	-	2009-03-13
				Placebo+Tritanrix-HB+Hib+Polio Sabin (Placebo Group)	窪鑰願鹹艱繭壓衊襯齋(顧選糧艱鹹廠廠願廠膚) = 艱顧獵餘夢繭蓋繭醖鬱範壓艱鹹選選構壓淵膚 (糧鬱範壓醖鬱餘夢醖齋, 廠顧淵範鬱蓋醖膚鹹鑰 ~ 繭衊網繭艱範遞獵遞鑰) 更多