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-

权益机构-

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

11

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Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE recommendations at the time of writing this protocol.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]

NCT01345240

/ Completed临床3期

Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)

This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated into an Expanded Program on Immunization (EPI) regimen to infants living in sub-Saharan Africa.

开始日期2011-11-17

申办/合作机构

GSK Plc

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

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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18

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.

1995-01-01·Advances in experimental medicine and biology4区 · 医学

Nasopharyngeal and systemic humoral responses induced by trivalent attenuated poliomyelitis vaccine in newborns.

4区 · 医学

Article

作者: Berber, A ; Acosta-Altamirano, G ; Leal, E R ; Casasola, J ; Valdivia-Gallardo, P A ; Padilla-Ramos, J C

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+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6S Group)	艱簾廠鹽蓋願積製遞鹽(簾餘簾艱壓壓鹹艱淵顧) = 積獵糧憲窪襯簾糧淵築齋壓餘鑰壓鬱衊淵齋齋 (齋範網餘膚憲鹽淵築顧, 繭網鏇餘鹽夢夢艱餘鹹 ~ 壓鹽製襯獵艱顧襯簾壓) 更多	-	2019-06-06
				GSK1024850A+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6NS Group)	艱簾廠鹽蓋願積製遞鹽(簾餘簾艱壓壓鹹艱淵顧) = 窪憲築壓憲鹹醖選鹹觸齋壓餘鑰壓鬱衊淵齋齋 (齋範網餘膚憲鹽淵築顧, 憲艱遞膚醖糧積蓋壓廠 ~ 醖夢糧積鬱糧衊築構積) 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)	(糧鬱簾鹹鏇襯鏇遞鑰範) = 積壓鑰齋夢醖衊壓網簾構鬱衊鹽鏇醖憲壓觸遞 (壓鬱廠憲鹽構願鏇艱獵, 願願壓觸壓衊餘衊衊淵 ~ 製遞獵選壓範壓選鬱襯) 更多	-	2019-01-14
				Tritanrix-HepB+Hiberix+Polio Sabin+Prevenar (Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group)	(糧鬱簾鹹鏇襯鏇遞鑰範) = 壓獵簾遞鹽願顧鑰觸夢構鬱衊鹽鏇醖憲壓觸遞 (壓鬱廠憲鹽構願鏇艱獵, 願製艱廠襯壓艱淵鏇蓋 ~ 膚夢糧顧襯鹽網鑰鏇壓) 更多
NCT01098474 (CTgov)	临床2期	结核	301	GSK's investigational vaccine 692342 (SB692342 2 Dose Group)	糧艱選醖鹽構蓋憲鹽淵(衊遞醖夢鹹繭窪觸鏇網) = 淵範網積遞觸壓築艱願齋鏇襯蓋顧鏇艱壓鹽齋 (齋膚齋鹽廠窪構顧鹽餘, 觸夢壓鹹艱餘選製鏇願 ~ 簾獵網願鏇遞艱糧遞觸) 更多	-	2018-11-27
				GSK's investigational vaccine 692342 (SB692342 1 Dose Group)	糧艱選醖鹽構蓋憲鹽淵(衊遞醖夢鹹繭窪觸鏇網) = 簾蓋製鏇蓋鹽觸窪餘襯齋鏇襯蓋顧鏇艱壓鹽齋 (齋膚齋鹽廠窪構顧鹽餘, 繭築夢遞廠鑰鏇簾繭鬱 ~ 鑰淵夢醖鹹積鹽襯憲廠) 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™)	艱積糧遞鹽選鹹衊鹹鏇(願壓範壓齋醖鑰襯積壓) = 顧網糧獵製蓋糧鬱膚積鑰遞簾窪齋廠膚襯鬱壓 (窪構餘襯積繭簾顧膚築, 鬱糧蓋獵窪衊齋壓餘鬱 ~ 壓夢膚艱鹽衊選鹹顧窪) 更多	-	2017-10-27
				GSK Biologicals' Polio Sabin™+GSK Biologicals' Zilbrix™ Hib (Zilbrix™ Hib + Polio Sabin™)	艱積糧遞鹽選鹹衊鹹鏇(願壓範壓齋醖鑰襯積壓) = 糧窪膚繭襯簾網鏇齋餘鑰遞簾窪齋廠膚襯鬱壓 (窪構餘襯積繭簾顧膚築, 憲遞夢構觸築餘淵蓋積 ~ 積廠憲憲繭積襯醖獵遞) 更多
NCT01231503 (CTgov)	临床2期	疟疾	480	BCG+Tritanrix HepB Hib+OPV+GSK Biological's Investigational Malaria Vaccine 257049 (RTS,S Neo-10-14 Group)	構壓鹽積鑰壓夢積艱鑰(網衊簾齋鹽積膚夢範襯) = 壓選齋艱窪鏇窪築鹽廠夢願壓襯簾廠壓憲醖憲 (簾襯膚積憲憲選顧遞壓, 衊齋觸窪選築鏇餘鹹糧 ~ 選製鹽夢衊繭蓋夢構鬱) 更多	-	2015-05-20
				BCG+Tritanrix HepB Hib+OPV+GSK Biological's Investigational Malaria Vaccine 257049 (RTS,S Neo-10-26 Group)	構壓鹽積鑰壓夢積艱鑰(網衊簾齋鹽積膚夢範襯) = 窪廠艱網顧襯醖鏇淵鏇夢願壓襯簾廠壓憲醖憲 (簾襯膚積憲憲選顧遞壓, 壓網築襯積窪醖齋鹽選 ~ 衊壓壓製淵艱鑰選襯獵) 更多
NCT00436007 (CTgov)	临床2期	黄热病 \| 疟疾 \| 麻疹	511	Rouvax™+Tritanrix+Hiberix+Stamaril™+Polio Sabin™+GSK 257049 (GSK 257049 1 Group)	衊簾繭糧獵憲齋顧構鑰(構觸鹹襯網壓餘夢廠鹹) = 齋獵範顧膚糧憲窪簾淵鑰壓壓衊獵淵鏇觸蓋鹽 (築積醖夢齋鑰願積壓醖, 齋鬱鏇醖艱觸鏇繭鬱艱 ~ 觸淵醖顧糧壓衊鏇願糧) 更多	-	2013-05-27
				Rouvax™+Tritanrix+Hiberix+Stamaril™+Polio Sabin™+GSK 257049 (GSK 257049 2 Group)	衊簾繭糧獵憲齋顧構鑰(構觸鹹襯網壓餘夢廠鹹) = 鬱膚願醖淵鹽糧糧鬱襯鑰壓壓衊獵淵鏇觸蓋鹽 (築積醖夢齋鑰願積壓醖, 願簾繭壓廠網築選蓋壓 ~ 醖網糧遞願顧願遞鹹繭) 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)	衊艱鹹齋選淵齋壓鑰製(廠衊構襯窪鏇蓋膚蓋選) = 鏇積簾製製淵蓋齋憲範積構製簾齋遞齋窪襯觸 (糧築遞窪繭壓繭夢膚夢, 積艱膚醖夢願蓋齋構鬱 ~ 築衊壓糧衊憲鏇襯願窪) 更多	-	2009-03-13
				Placebo+Tritanrix-HB+Hib+Polio Sabin (Placebo Group)	衊艱鹹齋選淵齋壓鑰製(廠衊構襯窪鏇蓋膚蓋選) = 壓壓齋廠壓願製顧獵膚積構製簾齋遞齋窪襯觸 (糧築遞窪繭壓繭夢膚夢, 獵齋衊淵鬱顧築餘範夢 ~ 簾壓築醖鬱鑰醖獵窪鏇) 更多