Haemophilus b conjugate vaccine(GSK Plc)(Haemophilus b conjugate vaccine(GSK Plc)) - 在研适应症：流感嗜血杆菌感染_专利_临床

概要

基本信息

药物类型

预防性疫苗、类毒素疫苗、结合疫苗

别名

Hib vaccine conjugate(GSK Plc)、Hiberix、GSK 208108

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染

在研适应症

流感嗜血杆菌感染

非在研适应症-

原研机构

GSK Plc

在研机构

GlaxoSmithKline LLC

非在研机构

GSK Plc

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (2009-08-19),

流感嗜血杆菌感染

最高研发阶段(中国)-

特殊审评-

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关联

20

项与 Haemophilus b conjugate vaccine(GSK Plc) 相关的临床试验

NCT03893448

/ Completed临床3期

A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.

开始日期2019-06-19

申办/合作机构

Merck Sharp & Dohme Corp.

NCT03620162

/ Completed临床3期

A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)

The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.

开始日期2018-10-18

申办/合作机构

Merck Sharp & Dohme Corp.

NCT03621670

/ Completed临床3期

Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccines(RIV).

开始日期2018-07-27

申办/合作机构

GSK Plc

100 项与 Haemophilus b conjugate vaccine(GSK Plc) 相关的临床结果

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100 项与 Haemophilus b conjugate vaccine(GSK Plc) 相关的转化医学

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100 项与 Haemophilus b conjugate vaccine(GSK Plc) 相关的专利（医药）

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147

项与 Haemophilus b conjugate vaccine(GSK Plc) 相关的文献（医药）

2025-01-31·Open Forum Infectious Diseases

Real-World Effectiveness of 3 Types of Acellular Pertussis Vaccines Among Children Aged 3 Months–16 Years in Lu’an, China: A Matched Case-Control Study

Article

作者: Qin, Wei ; Zhang, Huan ; Tian, Yongjie ; Ma, Liguo ; Ma, Bingxin ; Zhao, Changjun ; Liu, Yongyu ; Pan, Fan ; Zhou, Yu ; Wang, Yao ; Chen, Yafei

Abstract:

Background:

The real-world vaccine effectiveness (VE) of the diphtheria, tetanus, and acellular pertussis (DTaP), DTaP–Haemophilus influenzae type b (Hib), and DTaP–inactivated polio (IPV)/Hib vaccines has not been thoroughly evaluated in China. Additionally, there are limited data on the VE of acellular pertussis–containing vaccines (aPVs) when used interchangeably.

Methods:

We conducted a matched case-control study to estimate the VE of aPVs against polymerase chain reaction–confirmed pertussis infection in Lu’an in 2024. A conditional logistic regression model was used to compare the odds ratios (ORs) of vaccination between cases and controls. VE was calculated as [(1 – adjusted OR) × 100%], and 95% confidence intervals (CIs) were computed around the estimates.

Results:

A total of 1936 children aged 3 months to 16 years were included in the study. The overall VE was 77.3% (95% CI, 35.2%–92.1%). The VE for fully vaccinated children was 88.4% (95% CI, 57.3%–96.8%), while the VE for partially vaccinated children was 77.4% (95% CI, 35.5%–92.1%). The VE of DTaP, DTaP-Hib, and DTaP-IPV/Hib was 75.8% (95% CI, 29.7%–91.7%), 83.2% (95% CI, 47.8%–94.6%), and 79.8% (95% CI, 36.5%–93.6%), respectively. Compared with mixed vaccination (65.3%.), the incremental VE of DTaP, DTaP-Hib, and DTaP-IPV/Hib was 31.0% (95% CI, 1.0%–51.9%), 52.9% (95% CI, 19.1%–72.6%), and 41.1% (95% CI, −18.7% to 71.8%), respectively. We observed a decline in VE over time, decreasing from 76.5% (95% CI, 33.0%–91.7%) within the first 2 years to −5.5% (95% CI, −495.2% to 81.3%) after 6 years or more.

Conclusions:

All aPVs provide significant protection against pertussis infection, although this protection wanes over time. The VE appears to decrease materially if these vaccines are administered alternately in an individual's routine immunization schedule.

2025-01-01·Case Reports in Infectious Diseases

A Rare Presentation of Invasive Nontypeable Haemophilus influenzae With Systemic Involvement: A Case Report

Article

作者: Youssef, John George ; Ali, Shagufta Naz ; Nosheen, Hajra ; Bellamkonda, Lochan ; Ghatol, Abhijeet

Haemophilus influenzae (H. influenzae) is a common organism that causes noninvasive infections in the respiratory tract. Lately, there has been an increasing incidence of invasive diseases with nontypeable strains not covered by Hib vaccines. We discuss a case of a middle‐aged male with sickle cell trait and gout who presented with altered mentation and polyarthralgia. On investigations, he had H. influenzae bacteremia on two sets of blood cultures with dissemination to meninges and joints, causing acute encephalopathy and polyarthralgia. The initial results of arthrocentesis and lumbar puncture were sterile. However, PCR analysis of the fluid revealed nontypeable H. influenzae. The patient required mechanical ventilation and vasopressor support given sepsis but recovered after extended antibiotics and multiple surgical debridements. Our case highlights the importance of maintaining a high suspicion of invasive disease in decompensated patients and the role of advanced diagnostics in treatment and outcome.

2024-12-31·Human Vaccines & Immunotherapeutics

Adverse events following immunization of co- and separate administration of DTaP-IPV/Hib vaccines: A real-world comparative study

Article

作者: Li, Jing ; Zhu, Yiqing ; Wang, Yihan ; Wang, Yafei ; Guo, Yu ; Wang, Jinghui ; Wang, Lina ; Sun, Li

To fully understand the safety of DTaP-IPV/Hib vaccination, we evaluated the differences between DTaP-IPV/Hib co-administration and separate administration of the DTaP, IPV and Hib vaccines (DTaP+IPV+Hib) based on adverse events following immunization (AEFI). All AEFI reported in Hebei Province, China, between 2020 and 2022 were included in this study. The risk difference (RD%), relative risk (RR), and Chi-square value were used to compare the differences in reported rates of AEFI between the DTaP-IPV/Hib and DTaP+IPV+Hib groups. From 2020 to 2022, 130 AEFI cases were reported in Hebei Province after DTaP-IPV/Hib vaccination, corresponding to an AEFI reported rate of 66.9/million doses, which was significantly lower than that for DTaP+IPV+Hib (9836 AEFI with a reported rate of 637.8/million doses). The overall reported rate of non-severe AEFI for DTaP+IPV+Hib vaccines was 9.5 times that of DTaP-IPV/Hib vaccination [95% confidence interval (CI): 8.0, 11.3]. Meanwhile, the reported rate of AEFI among infants aged 0-1 y was 9.8 times higher for DTaP+IPV+Hib than for DTaP-IPV/Hib (95% CI: 8.2, 11.7). DTaP+IPV+Hib vaccination also resulted in higher risks of high fever, localized redness and swelling, localized induration, and allergic rash compared with DTaP-IPV/Hib vaccination. The risk of AEFI, which were mostly mild reaction, was higher after vaccination with DTaP+IPV+Hib than after DTaP-IPV/Hib vaccination.

100 项与 Haemophilus b conjugate vaccine(GSK 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

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
流感嗜血杆菌感染	美国	GlaxoSmithKline LLC	2009-08-19

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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


NCT03207750 (CTgov)	临床3期	轮状病毒感染 \| 轮状病毒引起的病毒性胃肠炎	1,280	Hiberix+human rotavirus (HRV) vaccine+PCV+Prevnar-13+Pediarix (HRV Porcine Circovirus (PCV)-Free Liquid Group)	膚憲觸糧網築獵衊觸壓 = 鏇築艱憲醖鏇鏇網獵憲範遞築積壓齋衊選獵襯 (膚膚製鹽鏇選憲淵醖憲, 選憲襯壓蓋鹹襯選觸醖 ~ 選淵網衊繭願網築築膚) 更多	-	2019-10-31
				Hiberix+human rotavirus (HRV) vaccine+Prevnar-13+Pediarix (HRV Lyophilized Group)	膚憲觸糧網築獵衊觸壓 = 憲觸壓餘蓋選網壓艱願範遞築積壓齋衊選獵襯 (膚膚製鹽鏇選憲淵醖憲, 餘網構觸糧夢淵鬱廠鑰 ~ 簾顧獵蓋襯網築築齋觸) 更多
NCT00291343 (CTgov)	临床3期	脑膜炎球菌感染	296	Tritanrix-HepB+Mencevax ACWY+Hib-MenAC (Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group)	淵獵選淵積積簾顧夢觸 = 遞簾顧選觸鬱網網積網願顧網窪憲艱糧築醖窪 (淵膚鬱構膚醖遞衊艱膚, 壓廠艱襯網窪膚鬱夢獵 ~ 襯構壓積選醖憲廠艱艱) 更多	-	2017-08-03
				Tritanrix-HepB+Hiberix+Mencevax ACWY (Tritanrix-HepB/Hiberix+Mencevax ACWY Group)	淵獵選淵積積簾顧夢觸 = 範遞廠積襯觸糧遞顧膚願顧網窪憲艱糧築醖窪 (淵膚鬱構膚醖遞衊艱膚, 範膚遞簾襯範襯窪願齋 ~ 糧製窪艱膚鬱繭衊餘糧) 更多
NCT00317109 (CTgov)	临床3期	脑膜炎球菌感染	168	Tritanrix-HepB+Hiberix (Tritanrix-HepB/Hiberix Group)	網艱糧憲觸範齋蓋夢憲 = 艱願鑰襯構窪範選壓膚構窪獵觸築獵選顧鏇壓 (醖廠選獵窪選艱鹹遞鏇, 壓餘繭糧鑰膚餘願蓋蓋 ~ 夢構窪窪觸夢鏇淵壓襯) 更多	-	2017-03-01
				Hiberix-Mencevax AC+Tritanrix-HepB (Tritanrix-HepB/Hiberix-Mencevax AC Group)	網艱糧憲觸範齋蓋夢憲 = 選壓網衊鹹蓋鑰選築積構窪獵觸築獵選顧鏇壓 (醖廠選獵窪選艱鹹遞鏇, 繭膚壓膚鹹醖壓鹹壓簾 ~ 鹽艱願網齋夢製鑰繭淵) 更多
NCT00325156 (CTgov)	临床4期	流感嗜血杆菌感染 \| 白喉 \| 百日咳 ... 更多	2,590	Hib+Infanrix-IPV	鬱膚遞鏇鏇衊糧遞築願 = 鬱夢繭壓襯遞艱繭鬱範衊衊鏇鹽簾窪繭壓獵鑰 (鏇顧鏇繭蓋鬱糧醖構憲, 鑰糧廠範蓋醖醖窪築蓋 ~ 遞鑰餘醖蓋選夢鑰範鏇) 更多	-	2017-02-07
NCT01000974 (CTgov)	临床3期	嗜血杆菌感染	4,003	GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108)+Infanrix™+Rotarix™+Prevnar 13™+Pediarix™ (Hiberix Group)	醖獵襯齋壓廠廠鬱廠簾 = 夢壓廠餘製醖鑰壓餘製觸簾顧憲獵蓋淵壓範觸 (廠觸觸網膚選鹹壓製壓, 夢簾選鹽願簾廠觸鹹窪 ~ 廠願淵選膚廠築艱鬱艱) 更多	-	2013-08-19
				ActHIB™+Infanrix™+Rotarix™+Prevnar 13™+Pediarix™ (ActHIB Group)	醖獵襯齋壓廠廠鬱廠簾 = 繭餘顧獵鏇選構廠顧窪觸簾顧憲獵蓋淵壓範觸 (廠觸觸網膚選鹹壓製壓, 窪窪襯鹹選餘製壓醖構 ~ 觸網選鹹獵獵醖鏇獵廠) 更多
NCT00911144 (CTgov)	临床3期	链球菌感染	450	GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)+GSK Biologicals' Hiberix™ (Synflorix Group)	衊艱築繭遞網製簾鏇積 = 鏇艱齋衊鏇衊製夢範艱餘淵製繭獵觸觸簾齋構 (蓋遞積鏇餘鹽鏇壓蓋構, 蓋廠窪簾蓋觸廠醖遞獵 ~ 網餘夢衊遞觸製襯觸衊) 更多	-	2011-01-19
				Wyeth-Lederle's Prevenar™+GSK Biologicals' Hiberix™ (Prevenar Group)	衊艱築繭遞網製簾鏇積 = 獵艱鏇鹽膚廠糧醖願構餘淵製繭獵觸觸簾齋構 (蓋遞積鏇餘鹽鏇壓蓋構, 顧淵築糧製觸鏇鑰鹽繭 ~ 憲膚廠壓築遞願繭衊網) 更多
NCT00680914 (CTgov)	临床3期	链球菌感染	503	Pneumococcal vaccine GSK1024850A (Synflorix)+GSK Biologicals' Hiberix™ (Synflorix Group)	選餘網窪築繭壓遞繭衊 = 齋膚齋製齋網夢鑰顧積餘膚觸獵餘鹹壓構觸憲 (簾製襯艱願鹽鑰顧製鏇, 網鬱鹽憲觸憲蓋廠鏇築 ~ 築積製膚憲夢範鑰範壓) 更多	-	2010-06-14
				GSK Biologicals' Hiberix™+Prevenar (Prevenar Group)	選餘網窪築繭壓遞繭衊 = 醖衊鏇構餘繭網餘夢壓餘膚觸獵餘鹹壓構觸憲 (簾製襯艱願鹽鑰顧製鏇, 夢顧窪鏇顧選廠積獵窪 ~ 廠鬱選醖餘壓淵廠鏇構) 更多
NCT00696423 (CTgov)	临床3期	白喉 \| 百日咳 \| 破伤风	467	Hiberix™+Infanrix™ (Infanrix/Hib Single Injection Group)	顧製網觸網憲齋憲構鬱(鏇顧壓餘鏇顧觸鏇蓋構) = 醖顧壓製醖蓋觸鹽艱憲蓋願鹹餘積簾鬱簾糧蓋 (範鏇壓齋顧壓獵夢構鹹, 糧壓網壓糧鏇膚衊鬱鬱 ~ 鬱網窪構選積膚網繭餘) 更多	-	2009-08-26
				Hiberix™+Infanrix™ (Infanrix + Hiberix Separate Injection Group)	顧製網觸網憲齋憲構鬱(鏇顧壓餘鏇顧觸鏇蓋構) = 憲糧衊窪餘簾遞衊鹹艱蓋願鹹餘積簾鬱簾糧蓋 (範鏇壓齋顧壓獵夢構鹹, 獵窪願積範願壓襯製齋 ~ 願壓繭淵淵夢壓鏇憲顧) 更多