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Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE recommendations at the time of writing this protocol.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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385

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

2024-02-01·Vaccine

Safety of incidental exposure to the novel oral poliovirus vaccine type 2 in pregnancy: A longitudinal observational study in Mozambique, 2022–2023

Article

作者: Bauhofer, Adilson ; Barata, Américo ; Lopez Cavestany, Rocio ; Jeyaseelan, Visalakshi ; Chissaque, Assucênio ; Jani, Ilesh Vinodrai ; de Deus, Nilsa ; Mach, Ondrej

BACKGROUNDTo minimize the risk of vaccine-derived poliovirus emergences, the novel oral poliovirus vaccine type 2 (nOPV2), was bioengineered to have increased genetic stability compared to Sabin OPV and recommended for outbreak response Emergency Use Listing by WHO. Although pregnant women are not a target population for this vaccine, a theoretical risk of incidental exposure exists via pharyngeal or faecal shedding from vaccinated children in the household or close community.METHODSThis was an observational study of pregnant women conducted in Nampula (exposed cohort) and Maputo (non-exposed cohort) in Mozambique from August 2022 to June 2023. Two nOPV2 campaigns were conducted in Nampula and none in Maputo. Women were followed-up during routine prenatal consultation, delivery, and 28-day neonate visits for obstetric anomalies and pregnancy outcomes. Sociodemographic, medical, and obstetric history was captured.RESULTSThree hundred twenty-six pregnant women were enrolled from Nampula and 940 from Maputo City. Stillbirth prevalence (2·3% vs 1·6%, p = 0·438), low birth weight (8·9% vs 8·2%, p = 0·989), congenital anomalies (1 % vs 0·5%, p = 0·454), neonatal death (2·3% vs 1·6%, p = 0·08), and maternal death (0 % vs 0·2%, p = 0·978) did not differ amongst exposed and non-exposed cohorts. There was an increased rate of pre-term delivery in the exposed cohort (18·4% vs 11·0%, p = 0·011).CONCLUSIONWe did not observe an increased frequency of adverse pregnancy outcomes due to passive nOPV2 exposure. A higher frequency of preterm delivery needs to be further investigated. The data reported herein support the continued use of nOPV2 for poliovirus outbreak response and full licensure of the vaccine.

2023-10-01·Medical Decision Making

Health Economic Analysis of Antiviral Drugs in the Global Polio Eradication Endgame

Article

作者: Badizadegan, Kamran ; Kalkowska, Dominika A. ; Thompson, Kimberly M.

Background Polio antiviral drugs (PAVDs) may provide a critical tool in the eradication endgame by stopping poliovirus infections in immunodeficient individuals who may not clear the virus without therapeutic intervention. Although prolonged/chronic poliovirus excreters are rare, they represent a source of poliovirus reintroduction into the general population. Prior studies that assumed the successful cessation of all oral poliovirus vaccine (OPV) use estimated the potential upper bound of the incremental net benefits (INBs) of resource investments in research and development of PAVDs. However, delays in polio eradication, OPV cessation, and the development of PAVDs necessitate an updated economic analysis to reevaluate the costs and benefits of further investments in PAVDs. Methods Using a global integrated model of polio transmission, immunity, vaccine dynamics, risks, and economics, we explore the risks of reintroduction of polio transmission due to immunodeficiency-related vaccine-derived poliovirus (iVDPV) excreters and reevaluate the upper bound of the INBs of PAVDs. Results Under the current conditions, for which the use of OPV will likely continue for the foreseeable future, even with successful eradication of type 1 wild poliovirus by the end of 2023 and continued use of Sabin OPV for outbreak response, we estimate an upper bound INB of 60 million US$2019. With >100 million US$2019 already invested in PAVD development and with the introduction of novel OPVs that are less likely to revert to neurovirulence, our analysis suggests the expected INBs of PAVDs would not offset their costs. Conclusions While PAVDs could play an important role in the polio endgame, their expected economic benefits drop with ongoing OPV use and poliovirus transmissions. However, stakeholders may pursue the development of PAVDs as a desired product regardless of their economic benefits. Highlights While polio antiviral drugs could play an important role in the polio endgame, their expected economic benefits continue to drop with delays in polio eradication and the continued use of oral poliovirus vaccines. The incremental net benefits of investments in polio antiviral drug development and screening for immunodeficiency-related circulating polioviruses are small. Limited global resources are better spent on increasing global population immunity to polioviruses to stop and prevent poliovirus transmission.

2023-09-01·The Lancet Infectious Diseases

Immunogenicity of novel oral poliovirus vaccine type 2 administered concomitantly with bivalent oral poliovirus vaccine: an open-label, non-inferiority, randomised, controlled trial

Article

作者: Anand, Abhijeet ; An, Qian ; Vertefeuille, John F ; Yunus, Mohammad ; Wilkinson, Amanda L ; Lickness, Jacquelyn S ; Kovacs, Stephanie D ; Abid, Talha ; Zhang, Yiting ; Coffee, Elizabeth ; Wassilak, Steven G F ; Burns, Cara C ; Mainou, Bernardo A ; Oberste, M Steven ; Zaman, Khalequ ; Konopka-Anstadt, Jennifer L ; Estivariz, Concepcion F ; Hoque, Masuma ; Pallansch, Mark A ; Snider, Cynthia J

BACKGROUNDNovel oral poliovirus vaccine type 2 (nOPV2) was developed by modifying the Sabin strain to increase genetic stability and reduce risk of seeding new circulating vaccine-derived poliovirus type 2 outbreaks. Bivalent oral poliovirus vaccine (bOPV; containing Sabin types 1 and 3) is the vaccine of choice for type 1 and type 3 outbreak responses. We aimed to assess immunological interference between nOPV2 and bOPV when administered concomitantly.METHODSWe conducted an open-label, non-inferiority, randomised, controlled trial at two clinical trial sites in Dhaka, Bangladesh. Healthy infants aged 6 weeks were randomly assigned (1:1:1) using block randomisation, stratified by site, to receive nOPV2 only, nOPV2 plus bOPV, or bOPV only, at the ages of 6 weeks, 10 weeks, and 14 weeks. Eligibility criteria included singleton and full term (≥37 weeks' gestation) birth and parents intending to remain in the study area for the duration of study follow-up activities. Poliovirus neutralising antibody titres were measured at the ages of 6 weeks, 10 weeks, 14 weeks, and 18 weeks. The primary outcome was cumulative immune response for all three poliovirus types at the age of 14 weeks (after two doses) and was assessed in the modified intention-to-treat population, which was restricted to participants with adequate blood specimens from all study visits. Safety was assessed in all participants who received at least one dose of study product. A non-inferiority margin of 10% was used to compare single and concomitant administration. This trial is registered with ClinicalTrials.gov, NCT04579510.FINDINGSBetween Feb 8 and Sept 26, 2021, 736 participants (244 in the nOPV2 only group, 246 in the nOPV2 plus bOPV group, and 246 in the bOPV only group) were enrolled and included in the modified intention-to-treat analysis. After two doses, 209 (86%; 95% CI 81-90) participants in the nOPV2 only group and 159 (65%; 58-70) participants in the nOPV2 plus bOPV group had a type 2 poliovirus immune response; 227 (92%; 88-95) participants in the nOPV2 plus bOPV group and 229 (93%; 89-96) participants in the bOPV only group had a type 1 response; and 216 (88%; 83-91) participants in the nOPV2 plus bOPV group and 212 (86%; 81-90) participants in the bOPV only group had a type 3 response. Co-administration was non-inferior to single administration for types 1 and 3, but not for type 2. There were 15 serious adverse events (including three deaths, one in each group, all attributable to sudden infant death syndrome); none were attributed to vaccination.INTERPRETATIONCo-administration of nOPV2 and bOPV interfered with immunogenicity for poliovirus type 2, but not for types 1 and 3. The blunted nOPV2 immunogenicity we observed would be a major drawback of using co-administration as a vaccination strategy.FUNDINGThe US Centers for Disease Control and Prevention.

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1期	马里	GSK Plc	2008-06-18
链球菌感染	临床1期	尼日利亚	GSK Plc	2008-06-18

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临床结果

适应症

分期

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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)	製廠襯廠築鑰齋餘鬱獵(構積遞廠顧鹹齋襯糧範) = 獵獵鑰窪鏇膚壓獵憲構餘衊壓蓋鑰觸鏇蓋繭願 (糧選餘鬱鏇衊艱顧製鑰, 築壓簾夢鬱襯夢鏇願衊 ~ 憲衊遞壓構製築簾壓醖) 更多	-	2019-06-06
				GSK1024850A (Synflorix)+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6NS Group)	製廠襯廠築鑰齋餘鬱獵(構積遞廠顧鹹齋襯糧範) = 鬱觸願襯鑰襯衊網齋廠餘衊壓蓋鑰觸鏇蓋繭願 (糧選餘鬱鏇衊艱顧製鑰, 淵鬱廠壓鬱壓構鏇淵構 ~ 衊淵夢製壓鏇蓋艱淵製) 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)	(築壓艱鬱壓製獵製膚積) = 築壓鏇範夢糧願襯鏇繭鹹壓鑰衊淵簾鏇獵鏇鏇 (鹹餘壓鏇積鏇選鏇觸鹹, 糧夢選鹹廠製繭鬱艱製 ~ 齋糧獵窪觸壓憲鑰窪範) 更多	-	2019-01-14
				Tritanrix-HepB+Hiberix+Polio Sabin+Prevenar (Wyeth) (Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group)	(築壓艱鬱壓製獵製膚積) = 製遞製鏇憲顧壓窪繭繭鹹壓鑰衊淵簾鏇獵鏇鏇 (鹹餘壓鏇積鏇選鏇觸鹹, 餘窪餘網鏇淵襯鑰選窪 ~ 襯鏇範製願鹹鏇範觸簾) 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™)	獵構艱顧醖積簾衊夢蓋(襯鹽蓋遞衊壓壓範膚夢) = 壓製壓糧廠簾糧蓋夢衊範醖衊鏇願醖膚窪夢積 (艱鹽淵鹽壓餘網鏇襯鹽, 繭艱鑰艱鏇鹽選膚鹹醖 ~ 夢簾獵膚鏇遞築鑰範憲) 更多	-	2017-10-27
				GSK Biologicals' Polio Sabin™+GSK Biologicals' Zilbrix™ Hib (Zilbrix™ Hib + Polio Sabin™)	獵構艱顧醖積簾衊夢蓋(襯鹽蓋遞衊壓壓範膚夢) = 獵襯網築鹽艱繭廠醖壓範醖衊鏇願醖膚窪夢積 (艱鹽淵鹽壓餘網鏇襯鹽, 鏇積鹹淵齋獵糧製襯衊 ~ 觸鹹鏇醖構選製廠糧鬱) 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)	願獵獵壓壓築廠蓋選鏇(齋鏇夢夢鹽夢鑰繭獵壓) = 淵觸鹽艱構積觸鹽襯構廠壓簾餘夢窪鹽獵鹹廠 (餘蓋餘醖鏇鏇網觸衊壓, 鹹鑰壓繭網廠遞淵衊選 ~ 網構獵窪繭遞願網選製) 更多	-	2015-05-20
				Rouvax+Tritanrix HepB Hib+BCG+OPV+GSK Biological's Investigational Malaria Vaccine 257049 (RTS,S Neo-10-26 Group)	願獵獵壓壓築廠蓋選鏇(齋鏇夢夢鹽夢鑰繭獵壓) = 鹹鏇壓廠鹹襯構鬱襯餘廠壓簾餘夢窪鹽獵鹹廠 (餘蓋餘醖鏇鏇網觸衊壓, 窪積選餘顧遞憲膚鬱製 ~ 艱積鑰膚選糧衊遞構醖) 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)	餘憲積蓋壓繭憲衊糧艱(蓋夢範淵窪簾壓憲鏇繭) = 夢窪鑰膚觸蓋鏇範齋憲觸壓願鏇選窪蓋壓艱觸 (獵繭糧餘鑰膚願網網築, 積齋醖襯製齋鹽範壓夢 ~ 夢憲齋製蓋衊窪糧齋積) 更多	-	2009-03-13
				Placebo+Tritanrix-HB+Hib+Polio Sabin (Placebo Group)	餘憲積蓋壓繭憲衊糧艱(蓋夢範淵窪簾壓憲鏇繭) = 構蓋選憲醖鹽構鏇鏇餘觸壓願鏇選窪蓋壓艱觸 (獵繭糧餘鑰膚願網網築, 繭廠觸蓋鹹膚膚範襯廠 ~ 製選構網鹹鬱淵鹽衊鹽) 更多