Pneumococcal vaccine recombinant(GlaxoSmithKline Plc)(Pneumococcal vaccine recombinant(GlaxoSmithKline Plc))

概要

基本信息

药物类型

预防性疫苗

别名

Pneumococcal vaccine recombinant、S. pneumoniae adult vaccine、2189242-A

+ [3]

靶点-

作用机制

免疫刺激剂

治疗领域

感染耳鼻咽喉疾病

在研适应症-

非在研适应症

耳感染中耳炎链球菌感染

原研机构

GSK Plc

在研机构-

非在研机构

GSK Plc

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

6

项与 Pneumococcal vaccine recombinant(GlaxoSmithKline Plc) 相关的临床试验

NCT01545375

/ Completed临床2期

Study to Determine Protective Efficacy Against Otitis Media and Assess Safety of an Investigational Pneumococcal Vaccine 2189242A in Healthy Infants

The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged less than 24 months, living in the southwestern US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the impact on acute lower respiratory tract infections (ALRI) up to the second year of life.

开始日期2012-05-21

申办/合作机构

GSK Plc

NCT01262872

/ Completed临床2期

Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety and Immunogenicity When Co-administered With Routine EPI Vaccines in Infants Following Safety Assessment in Children Aged 2-4 Years in The Gambia

This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and co-administered with other routine paediatric vaccines in infants in The Gambia. Two formulations containing different doses of pneumococcal antigen and two different schedules will be tested in infants.

开始日期2011-02-09

申办/合作机构

GSK Plc

[+3]

NCT01204658

/ Completed临床2期

Safety, Reactogenicity & Immunogenicity of GSK Biologicals' Pneumococcal Vaccine 2189242A When Co-administered With DTPa-HBV-IPV/Hib Vaccine in Healthy Infants

This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with DTPa-HBV-IPV/Hib vaccine.

开始日期2010-09-27

申办/合作机构

GSK Plc

100 项与 Pneumococcal vaccine recombinant(GlaxoSmithKline Plc) 相关的临床结果

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100 项与 Pneumococcal vaccine recombinant(GlaxoSmithKline Plc) 相关的转化医学

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100 项与 Pneumococcal vaccine recombinant(GlaxoSmithKline Plc) 相关的专利（医药）

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98

项与 Pneumococcal vaccine recombinant(GlaxoSmithKline Plc) 相关的文献（医药）

2024-12-01·Vaccine: X

Immunogenicities of vaccines including the immunoglobulin M-degrading enzyme of Streptococcus suis, rIde , and protective efficacy against serotype 14 in piglets

Article

作者: Liedel, C ; Mayer, L ; Baums, C G ; Rieckmann, K ; Klose, K ; de Greeff, A

Streptococcus suis (S. suis) is a major porcine pathogen. Some strains have a substantial zoonotic potential such as serotype (cps) 14 as the second most important cps in human infections. To this date no licensed S. suis vaccine is available in Europe though subunit vaccines and bacterins have been examined by several scientific groups worldwide. Objectives of this study were to determine protective efficacy of rIde _Ssuis vaccination against intranasal S. suis cps14 challenge in conventional weaned piglets and to investigate additionally immunogenicity of rIde _Ssuis vaccination in cesarean-derived colostrum-deprived (CDCD) piglets. Immunization led to reduction of bacterial multiplicity in porcine blood and delayed onset of clinical signs of cps14 disease in conventional rIde _Ssuis -vaccinated piglets. However, significant differences were not recorded which might be related to comparable low anti-Ide _Ssuis antibody levels and insufficient neutralization of IgM protease activity in this animal experiment. In contrast, immunization of cesarean-derived colostrum-deprived piglets with rIde _Ssuis resulted in high α-rIde _Ssuis IgG antibody levels and a highly significant reduction of the survival factor of the cps14 challenge strain in porcine blood in vitro. In conclusion, the results of this study indicate bactericidal immunity against S. suis cps14 by Ide _Ssuis specific immunity.

2024-12-01·The Lancet regional health. Southeast Asia

Routine immunization against Streptococcus pneumoniae and Haemophilus influenzae type B and antibiotic consumption in India: a dynamic modeling analysis

Article

作者: Parameswaran, Giridara Gopal ; Gleason, Alec C ; Klein, Eili ; Laxminarayan, Ramanan ; Kumar, Chirag K ; Gleason, Alec C. ; Nandi, Arindam ; Summan, Amit ; Kumar, Chirag K.

Background:

Childhood vaccinations can reduce disease burden and associated antibiotic use, in turn reducing the risk of antimicrobial resistance (AMR). We retrospectively estimated the population-level reductions in antibiotic use in India following the introduction of vaccines against Streptococcus pneumoniae and Haemophilius influenzae type B in the national immunization program for children in the mid-2010s and projected future gains to 2028 if vaccination coverage were to be increased.

Methods:

Using IndiaSim, a dynamic agent-based microsimulation model (ABM) for India, we simulated the spread of Streptococcus pneumoniae and Haemophilius influenzae type B (Hib) among children to estimate reductions in antibiotic use under the scenarios of: (i) pneumococcal and Hib vaccine coverage levels equivalent to the national coverage of pentavalent diphtheria-pertussis-tetanus third dose (DPT3) compared to a baseline of no vaccination, and (ii) near-universal (90%) coverage of the vaccines compared to pre-COVID national DPT3-level coverage. Model parameters, including national DPT3 coverage rates, were based on data from the National Family Household Survey 2015-2016 and other published sources. We quantified reductions in antibiotic consumption nationally and by state and wealth quintiles.

Findings:

We estimate that coverage of S. pneumoniae and Hib vaccines at the same level as DPT3 in India would translate to a 61.4% [95% UI: 43.8-69.5] reduction in attributable antibiotic use compared to a baseline of zero vaccination coverage. Increases in childhood vaccination coverage between 2004 and 2016 have likely reduced attributable antibiotic demand by as much as 93.4% among the poorest quintile. Increasing vaccination coverage by an additional 11 percentage points from 2016 levels results in mortality and antibiotic use across wealth quintiles becoming increasingly similar (p < 0.05), reducing in health inquities. We project that near-universal vaccine coverage would further reduce inequities in antibiotic demand and may eliminate of outbreak-associated antibiotic use from S. pneumoniae and Hib.

Interpretation:

Though vaccination has a complex relationship with antibiotic use because both are modulated by socioeconomic factors, increasing vaccinations for S. pneumoniae and Hib may have a significant impact on reducing antibiotic use and improving health outcomes among the poorest individuals.

Funding:

The Bill & Melinda Gates Foundation (grant numbers OPP1158136 and OPP1190803).

2023-09-18·Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Safety of Streptococcus pyogenes Vaccines: Anticipating and Overcoming Challenges for Clinical Trials and Post-Marketing Monitoring.

Article

作者: Kim, Jerome H ; Steer, Andrew C ; Asturias, Edwin J ; Excler, Jean-Louis ; Zühlke, Liesl ; Long, Raj ; Sriskandan, Shiranee ; Sun, Wellington ; McCulloch, Mignon ; Dale, James B ; Cavaleri, Marco ; Fulurija, Alma ; Ackland, James

Streptococcus pyogenes (Strep A) infections result in a vastly underestimated burden of acute and chronic disease globally. The Strep A Vaccine Global Consortium's (SAVAC's) mission is to accelerate the development of safe, effective, and affordable S. pyogenes vaccines. The safety of vaccine recipients is of paramount importance. A single S. pyogenes vaccine clinical trial conducted in the 1960s raised important safety concerns. A SAVAC Safety Working Group was established to review the safety assessment methodology and results of more recent early-phase clinical trials and to consider future challenges for vaccine safety assessments across all phases of vaccine development. No clinical or biological safety signals were detected in any of these early-phase trials in the modern era. Improvements in vaccine safety assessments need further consideration, particularly for pediatric clinical trials, large-scale efficacy trials, and preparation for post-marketing pharmacovigilance.

100 项与 Pneumococcal vaccine recombinant(GlaxoSmithKline Plc) 相关的药物交易

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研发状态

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
耳感染	临床2期	美国	GSK Plc	2012-05-21
中耳炎	临床2期	美国	GSK Plc	2012-05-21
链球菌感染	临床2期	比利时	GSK Plc	2009-05-18

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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


NCT00985751 (CTgov)	临床2期	链球菌感染	257	Synflorix (Synflorix Group)	鏇夢獵鑰鹹鏇願選餘鏇(築鬱顧簾願簾構壓膚襯) = 範觸鹽獵構淵襯顧淵糧蓋觸觸醖願壓糧製觸餘 (鹹簾壓製醖壓積製衊獵, 範鏇積糧獵廠鹽顧鑰製 ~ 繭壓繭鬱窪範餘壓鹹鏇) 更多	-	2017-10-06
				Synflorix+GSK 2189242A (Synflorix/GSK 2189242A Group)	鏇夢獵鑰鹹鏇願選餘鏇(築鬱顧簾願簾構壓膚襯) = 構鬱簾願糧鬱壓願夢廠蓋觸觸醖願壓糧製觸餘 (鹹簾壓製醖壓積製衊獵, 壓獵膚簾範積膚憲醖製 ~ 醖繭構構衊網願範淵選)
NCT01545375 (CTgov)	临床2期	链球菌感染 \| 耳感染 \| 中耳炎	1,806	Pneumococcal vaccine GSK2189242A+PedvaxHIB®+Prevnar 13® (dPly-PhtD Group)	網壓選繭壓築壓鹽鑰網(糧積鹽醖觸遞鏇鏇壓鏇) = 製襯製鬱廠網糧齋夢觸繭鹽築艱遞鹽範壓選夢 (遞簾淵艱製糧蓋顧鹹鏇, 醖積繭觸蓋範憲廠鏇積 ~ 廠憲窪鏇選網選憲膚願) 更多	-	2017-09-12
				Placebo+PedvaxHIB®+Prevnar 13® (Control Group)	網壓選繭壓築壓鹽鑰網(糧積鹽醖觸遞鏇鏇壓鏇) = 顧蓋範齋襯壓鑰憲襯鬱繭鹽築艱遞鹽範壓選夢 (遞簾淵艱製糧蓋顧鹹鏇, 積遞夢憲積遞鹹醖蓋顧 ~ 壓夢繭廠糧齋艱廠範醖) 更多
NCT00896064 (CTgov)	临床2期	链球菌感染	43	GSK2189242A (GSK2189242A Formulation 1 Group)	繭齋蓋鹽積網鏇網鬱壓(觸衊鹽夢壓壓齋獵選繭) = 蓋願膚鹹壓獵繭艱醖範觸艱襯顧餘願範製築選 (夢範遞積遞簾壓鑰廠衊, 鏇願壓築鬱齋鑰夢鹹觸 ~ 膚憲積積餘觸獵網蓋醖) 更多	-	2017-07-19
				GSK2189242A (GSK2189242A Formulation 2 Group)	繭齋蓋鹽積網鏇網鬱壓(觸衊鹽夢壓壓齋獵選繭) = 鏇鹽襯簾衊積淵廠築鹽觸艱襯顧餘願範製築選 (夢範遞積遞簾壓鑰廠衊, 構鑰鏇鑰遞艱獵繭憲鹽 ~ 積齋製襯鏇襯壓窪鏇願) 更多
NCT01204658 (CTgov)	临床2期	链球菌感染	576	Pneumococcal vaccine GSK 2189242A (LD formulation 1)+Infanrix Hexa (DTPa-HBV-IPV/Hib) (10PP-LD/Infanrix Hexa Group)	築觸夢簾鹽淵鏇襯餘顧(窪齋遞蓋膚願獵壓積醖) = 糧願築衊衊襯鑰衊窪顧觸糧獵獵壓醖構願鬱願 (鬱壓獵鏇艱繭範齋製觸, 壓艱觸鑰觸網廠簾觸窪 ~ 醖遞鑰願窪夢簾膚壓積) 更多	-	2016-09-28
				Pneumococcal vaccine GSK 2189242A (HD formulation 2)+Infanrix Hexa (DTPa-HBV-IPV/Hib) (10PP-HD/Infanrix Hexa Group)	築觸夢簾鹽淵鏇襯餘顧(窪齋遞蓋膚願獵壓積醖) = 膚廠憲憲網膚鹽淵築蓋觸糧獵獵壓醖構願鬱願 (鬱壓獵鏇艱繭範齋製觸, 鏇鏇鹽積淵鏇糧構觸鑰 ~ 鏇觸齋繭獵衊鹽觸淵獵) 更多