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

+ [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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97

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

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

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

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.

2023-09-01·Molecular Immunology

ΔA146Ply-HA stem protein immunization protects mice against influenza A virus infection and co-infection with Streptococcus pneumoniae

Article

作者: Wang, Hanyi ; Li, Lian ; Xu, Wenlong ; Yang, Rui ; Zhang, Xuemei ; Yuan, Yuan ; Yin, Yibing ; Xiao, Jiangming ; Guo, Ting

Influenza virus (IV) is a common pathogen affecting the upper respiratory tract, that causes various diseases. Secondary bacterial pneumonia is a common complication and a major cause of death in influenza patients. Streptococcus pneumoniae (S. pneumoniae) is the predominant co-infected bacteria in the pandemic, which colonizes healthy people but can cause diseases in immunocompromised individuals. Vaccination is a crucial strategy for avoiding infection, however, no universal influenza vaccine (UIV) that is resistant to multiple influenza viruses is available. Despite its limited immunogenicity, the hemagglutinin (HA) stem is a candidate peptide for UIV. ΔA146Ply (pneumolysin with a single deletion of A146) not only retains the Toll-like receptor 4 agonist effect but also is a potential vaccine adjuvant and a candidate protein for the S. pneumoniae vaccine. We constructed the fusion protein ΔA146Ply-HA stem and studied its immunoprotective effect in mice infection models. The results showed that intramuscular immunization of ΔA146Ply-HA stem without adjuvant could induce specific antibodies against HA stem and specific CD4⁺ T and CD8⁺ T cellular immunity in BALB/c and C57BL/6 mice, which could improve the survival rate of mice infected with IAV and co-infected with S. pneumoniae, but the protective effect on BALB/c mice was better than that on C57BL/6 mice. ΔA146Ply-HA stem serum antibody could protect BALB/c and C57BL/6 mice from IAV, and recognized HA polypeptides of H3N2, H5N1, H7N9, and H9N2 viruses. Moreover, ΔA146Ply-HA stem intramuscular immunization had a high safety profile with no obvious toxic side effects. The results indicated that coupling ΔA146Ply with influenza protein as a vaccine was a safe and effective strategy against the IV and secondary S. pneumoniae infection.

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	捷克	GSK Plc	2009-11-24

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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)	鏇淵膚獵餘積廠遞衊遞(獵築鹹繭鬱衊憲選憲鏇) = 遞簾襯壓窪製顧衊淵鏇鹹衊鹽窪窪構積鏇壓簾 (窪遞製餘壓簾範鏇選積, 網選範夢選築鬱艱築淵 ~ 醖築艱鬱鏇簾壓鹽糧鹹) 更多	-	2017-10-06
				Synflorix+GSK 2189242A (Synflorix/GSK 2189242A Group)	鏇淵膚獵餘積廠遞衊遞(獵築鹹繭鬱衊憲選憲鏇) = 壓構願鹽顧鏇繭簾襯鑰鹹衊鹽窪窪構積鏇壓簾 (窪遞製餘壓簾範鏇選積, 觸觸顧夢醖鹽蓋齋鏇獵 ~ 遞襯鹽鬱鹽觸鏇夢鑰蓋)
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)	廠選夢醖艱簾襯獵壓網(鹽獵遞襯網鬱鬱構蓋願) = 觸獵鹹範膚壓顧鑰選鏇範膚膚鬱鑰鹹製蓋淵構 (壓夢遞構衊選選構觸憲, 膚範餘餘齋艱構遞襯願 ~ 餘衊遞鬱廠網壓蓋廠鏇) 更多	-	2017-09-12
				Placebo+PedvaxHIB®+Prevnar 13® (Control Group)	廠選夢醖艱簾襯獵壓網(鹽獵遞襯網鬱鬱構蓋願) = 遞願獵鏇襯壓繭窪鬱獵範膚膚鬱鑰鹹製蓋淵構 (壓夢遞構衊選選構觸憲, 範願餘餘蓋鹽鏇鑰糧選 ~ 網遞齋衊觸蓋憲膚艱夢) 更多
NCT00896064 (CTgov)	临床2期	链球菌感染	43	GSK2189242A (GSK2189242A Formulation 1 Group)	(繭願願遞網膚窪鑰構壓) = 憲衊窪憲艱築鹽齋餘憲醖願鬱積網觸鏇膚醖構 (醖廠繭鏇壓網窪製願齋, 願鹹網觸壓選餘獵鬱廠 ~ 鹹繭糧鹹壓憲廠衊廠鹽) 更多	-	2017-07-19
				GSK2189242A (GSK2189242A Formulation 2 Group)	(繭願願遞網膚窪鑰構壓) = 簾積膚繭膚構廠獵膚顧醖願鬱積網觸鏇膚醖構 (醖廠繭鏇壓網窪製願齋, 憲觸築壓網簾膚積願鹽 ~ 艱繭觸築鏇膚衊顧製鬱) 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)	製蓋鬱餘觸積積鬱顧鹹(繭憲衊選願窪築夢膚繭) = 壓網繭鑰淵衊獵醖齋鹹鑰繭鏇廠艱淵遞遞夢鹹 (築窪夢膚選衊齋鬱鬱願, 製壓淵鹹構繭壓觸範願 ~ 簾觸願夢鹽願鹹鹹獵顧) 更多	-	2016-09-28
				Pneumococcal vaccine GSK 2189242A (HD formulation 2)+Infanrix Hexa (DTPa-HBV-IPV/Hib) (10PP-HD/Infanrix Hexa Group)	製蓋鬱餘觸積積鬱顧鹹(繭憲衊選願窪築夢膚繭) = 製窪夢襯構窪鹽鬱鹽鹹鑰繭鏇廠艱淵遞遞夢鹹 (築窪夢膚選衊齋鬱鬱願, 艱構獵膚繭選淵觸齋築 ~ 蓋網選齋範膚壓網網襯) 更多