DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc)(DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc))

概要

基本信息

药物类型

预防性疫苗、类毒素疫苗

别名

Zilbrix-Hib

靶点-

作用机制

免疫刺激剂

治疗领域

感染消化系统疾病呼吸系统疾病+ [1]

在研适应症-

非在研适应症

白喉嗜血杆菌感染乙型肝炎+ [3]

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3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

3

项与 DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc) 相关的临床试验

NCT00678301

/ Completed临床3期

Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Zilbrix™ Hib and Polio Sabin™

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of African Sub-Saharan infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4 months of life.

开始日期2008-06-18

申办/合作机构

GSK Plc

NCT00473668

/ Completed临床3期

Non-inferiority of One Formulation of GSK Biologicals' DTPw-HBV/Hib to 2 Formulations of GSK Biologicals' DTPw-HBV/Hib With Respect to the Immune Response to the PRP Antigen, When Administered to Healthy Infants at 6, 10, 14 Weeks of Age

The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

开始日期2007-06-01

申办/合作机构

GSK Plc

NCT00332566

/ Completed临床3期

Immunogenicity, Reactogenicity & Safety of a Booster Dose of GSK Biologicals' DTPw-HBV/Hib Kft Vaccine Vs GSK Biologicals' DTPw-HBV/Hib Vaccine, in Infants Who Received a 3-Dose Primary Vaccination Course With the Same Vaccines.

This booster study will assess the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy children, 18 to 24 months of age, who received the same vaccine for primary vaccination. Prior to the booster dose, this study will also assess the persistence of antibodies to the vaccine antigen components administered in the primary vaccination course. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

开始日期2006-06-01

申办/合作机构

GSK Plc

100 项与 DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc) 相关的临床结果

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100 项与 DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc) 相关的转化医学

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100 项与 DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc) 相关的专利（医药）

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2

项与 DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc) 相关的文献（医药）

2008-04-01·Expert Opinion on Biological Therapy3区 · 医学

Clinical experience with DTPw-HBV and DTPw-HBV/Hib combination vaccines

3区 · 医学

Review

作者: Stanislav Plisek ; Roman Prymula

BACKGROUNDCombined diphtheria-tetanus-whole-cell pertussis (DTPw) vaccines remain the cornerstone of many childhood vaccination programs. Larger DTPw-based combination vaccines facilitate high coverage and protection against other childhood pathogens, such as hepatitis B (HBV) and Haemophilus influenzae type b (Hib). Such vaccines have been available since the mid-1990s (Tritanrix-HBV and Tritanrix-HBV/Hib; GlaxoSmithKline [GSK] Biologicals), demonstrating excellent immunogenicity in various schedules. In order to address growing demand for DTPw-based vaccines, GSK Biologicals have developed the Zilbrix range using a new DTPw antigen source and containing reduced quantities of polyribosylribitol phosphate [PRP].OBJECTIVEThis article presents clinical trial results for both DTPw-based vaccines.METHODSGSK Biologicals provided a comprehensive data package, which was supplemented with a Medline literature search.CONCLUSIONNew antigen sources and reduced PRP will ensure the continued supply of DTPw-based combination vaccines for vital global mass vaccination campaigns.

PLOS ONE3区 · 综合性期刊

HIV-Infected or -Exposed Children Exhibit Lower Immunogenicity to Hepatitis B Vaccine in Yaoundé, Cameroon: An Appeal for Revised Policies in Tropical Settings?

3区 · 综合性期刊

ArticleOA

作者: Njom Nlend, Anne Esther ; Tchidjou, Hyppolite Kuekou ; Penlap, Véronique ; Pieme, Constant Anatole ; Ngounouh, Christian Taheu ; Nguwoh, Philippe Salomon ; Moyou, Roger Somo ; Colizzi, Vittorio ; Fokam, Joseph ; Otélé, Jean Mbede

BACKGROUNDSince 2005, anti-hepatitis B virus (anti-HBV) vaccine is part of the Expanded Program on Immunization (EPI) for infants born in Cameroon, with 99% anti-HBV coverage. In a context of generalized HIV epidemiology, we assessed paediatric anti-HBV vaccine response according to HIV status, feeding option and age in a tropical context.METHODOLOGYProspective, observational and cross-sectional study conducted among 82 children (27 [IQR: 9-47] months, min-max: 6-59), after complete anti-HBV vaccination (Zilbrix Hepta: 10μg AgHBs) at the Essos Health Centre in Yaounde, Cameroon, classified as group-A: HIV unexposed (28), group-B: HIV-exposed/uninfected (29), group-C: HIV-infected (25). Quantitative anti-HBs ELISA was interpreted as "no", "low-" or "protective-response" with <1, 1-10, or ≥10 IU/L respectively; with p-value<0.05 considered significant.RESULTSChildren were all HBV-unexposed (AcHBc-negative) and uninfected (HBsAg-negative). Response to anti-HBV vaccine was 80.49% (66/82), with only 45.12% (37/82) developed a protective-response (≥10IU/L). According to HIV status, 60.71% (17/28) developed a protective-response in group-A, vs. 51.72% (15/29) and 20% (5/25) in group-B and group-C respectively, Odds Ratio (OR): 2.627 [CI95% 0.933-7.500], p = 0.041. According to feeding option during first six months of life, 47.67% (21/45) developed a protective-response on exclusive breastfeeding vs. 43.24% (16/37) on mixed or formula feeding, OR: 1.148 [CI95% 0.437-3.026], p = 0.757. According to age, protective-response decreased significantly as children grow older: 58.33% (28/48) <24 months vs. 26.47% (9/34) ≥24 months, OR: 3.889 [CI95% 1.362-11.356], p = 0.004; and specifically 67.65% (23/34) ≤6 months vs. 0%, (0/5) 33-41 months, p = 0.008.CONCLUSIONSAnti-HBV vaccine provides low rate of protection (<50%) among children in general, and particularly if HIV-exposed, infected and/or older children. Implementing policies for early vaccination, specific immunization algorithm for HIV-exposed/infected children, and monitoring vaccine response would ensure effective protection in tropical settings, pending extensive/confirmatory investigations.

100 项与 DTPw-HBV/Hib Kft vaccine(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
白喉	临床3期	尼加拉瓜	GSK Plc	2006-06-01
白喉	临床3期	阿根廷	GSK Plc	2006-06-01
嗜血杆菌感染	临床3期	尼加拉瓜	GSK Plc	2006-06-01
嗜血杆菌感染	临床3期	阿根廷	GSK Plc	2006-06-01
乙型肝炎	临床3期	尼加拉瓜	GSK Plc	2006-06-01
乙型肝炎	临床3期	阿根廷	GSK Plc	2006-06-01
破伤风	临床3期	阿根廷	GSK Plc	2006-06-01
破伤风	临床3期	尼加拉瓜	GSK Plc	2006-06-01
百日咳	临床3期	尼加拉瓜	GSK Plc	2006-06-01
百日咳	临床3期	阿根廷	GSK Plc	2006-06-01

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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


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™)	蓋齋膚窪積憲壓廠觸鬱(築遞壓顧願窪顧鹹窪壓) = 網鹽壓鹹衊醖壓鹽築鑰築築選繭簾顧醖廠繭積 (遞糧顧製鑰構糧選構遞, 鬱積遞醖鏇觸廠製壓繭 ~ 網醖簾鏇構襯齋願憲遞) 更多	-	2017-10-27
				GSK Biologicals' Polio Sabin™+GSK Biologicals' Zilbrix™ Hib (Zilbrix™ Hib + Polio Sabin™)	蓋齋膚窪積憲壓廠觸鬱(築遞壓顧願窪顧鹹窪壓) = 糧範艱構積鹽艱蓋夢醖築築選繭簾顧醖廠繭積 (遞糧顧製鑰構糧選構遞, 網獵鑰糧觸築顧夢鏇衊 ~ 範廠糧艱艱鏇構繭襯艱) 更多
NCT00473668 (CTgov)	临床3期	白喉 \| 乙型肝炎 \| 嗜血杆菌感染 \| 百日咳 \| 破伤风	300	Zilbrix-Hib (Tritanrix-HepB/Hiberix Kft. Group)	顧遞範製願淵糧遞夢餘(遞鑰鑰膚願蓋窪憲淵獵) = 憲鏇餘鏇壓顧範餘簾窪鏇衊願遞艱構顧窪獵糧 (鹹衊齋簾夢糧鹽艱淵範, 淵糧齋網醖選壓鹹製餘 ~ 膚鹽糧遞淵壓淵齋遞壓) 更多	-	2017-08-18
				Tritanrix™-HepB+Hiberix™ (Tritanrix-HepB/Hiberix LD Group)	顧遞範製願淵糧遞夢餘(遞鑰鑰膚願蓋窪憲淵獵) = 廠衊選醖構膚鹽廠窪鬱鏇衊願遞艱構顧窪獵糧 (鹹衊齋簾夢糧鹽艱淵範, 構築襯簾餘鏇蓋鹽觸網 ~ 鏇壓獵鹽膚鹹網糧餘選) 更多
NCT00473668 (Pubmed \| BMC Infect Dis)	临床3期	白喉 \| 乙型肝炎 \| 嗜血杆菌感染 \| 百日咳 \| 破伤风	299	DTPw-HBV/Hib vaccine (DTPw-HBV/Hib2.5 [Kft])	艱淵鬱鹽觸簾獵衊襯夢(遞鏇膚範壓鬱願構鏇廠) = 齋壓壓醖選衊繭積淵築遞範鑰醖遞觸齋醖鬱鹹 (衊範鑰遞繭衊壓窪廠鬱 ) 更多	积极	2010-10-15
				DTPw-HBV/Hib vaccine (DTPw-HBV/Hib)	艱淵鬱鹽觸簾獵衊襯夢(遞鏇膚範壓鬱願構鏇廠) = 蓋顧鑰獵鑰顧繭觸簾膚遞範鑰醖遞觸齋醖鬱鹹 (衊範鑰遞繭衊壓窪廠鬱 ) 更多