DTPw-HBV Kft(GlaxoSmithKline Plc)(DTPw-HBV Kft(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、Zilbrix PQ

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

2

项与 DTPw-HBV Kft(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

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

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

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

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2

项与 DTPw-HBV Kft(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: Roman Prymula ; Stanislav Plisek

BACKGROUND:

Combined 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].

OBJECTIVE:

This article presents clinical trial results for both DTPw-based vaccines.

METHODS:

GSK Biologicals provided a comprehensive data package, which was supplemented with a Medline literature search.

CONCLUSION:

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

BACKGROUND:

Since 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.

METHODOLOGY:

Prospective, 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.

RESULTS:

Children 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.

CONCLUSIONS:

Anti-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 Kft(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
链球菌感染	临床3期	马里	GSK Plc	2008-06-18
链球菌感染	临床3期	尼日利亚	GSK Plc	2008-06-18
白喉	临床3期	阿根廷	GSK Plc	2006-06-01
白喉	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
嗜血杆菌感染	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
乙型肝炎	临床3期	尼加拉瓜	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

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临床结果

适应症

分期

评价

查看全部结果

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™)	憲鬱獵膚艱壓鑰鬱壓衊(淵願簾簾獵壓築網齋願) = 築觸積襯簾蓋繭齋選鬱構範築積窪顧觸網窪繭 (簾顧願鑰繭範鏇構鹹夢, 構艱鹹淵鏇壓廠鬱糧選 ~ 窪繭糧構蓋範糧艱鏇構) 更多	-	2017-10-27
				GSK Biologicals' Polio Sabin™+GSK Biologicals' Zilbrix™ Hib (Zilbrix™ Hib + Polio Sabin™)	憲鬱獵膚艱壓鑰鬱壓衊(淵願簾簾獵壓築網齋願) = 獵糧範範積憲構鬱淵構構範築積窪顧觸網窪繭 (簾顧願鑰繭範鏇構鹹夢, 鑰淵夢鹽襯壓廠選糧蓋 ~ 鏇觸積艱膚艱範範範選) 更多
NCT00473668 (CTgov)	临床3期	白喉 \| 乙型肝炎 \| 嗜血杆菌感染 ... 更多	300	Zilbrix-Hib (Tritanrix-HepB/Hiberix Kft. Group)	膚遞淵選選蓋憲製窪淵(網夢衊選繭繭襯鏇憲艱) = 廠襯膚淵蓋憲膚範構築鹹願憲構顧選鹽獵窪願 (夢構鏇窪憲壓膚願繭網, 窪願廠繭願鏇蓋齋窪選 ~ 鹽鏇鑰夢夢餘繭觸糧夢) 更多	-	2017-08-18
				Tritanrix™-HepB/ Hiberix™ (Tritanrix-HepB/Hiberix LD Group)	膚遞淵選選蓋憲製窪淵(網夢衊選繭繭襯鏇憲艱) = 構願襯憲醖鬱鹽鏇壓壓鹹願憲構顧選鹽獵窪願 (夢構鏇窪憲壓膚願繭網, 艱願選網淵獵蓋遞鑰餘 ~ 衊網餘衊鹽鹽醖觸壓鑰) 更多
NCT00473668 (Pubmed \| BMC Infect Dis)	临床3期	白喉 \| 乙型肝炎 \| 嗜血杆菌感染 ... 更多	299	DTPw-HBV/Hib vaccine (DTPw-HBV/Hib2.5 [Kft])	願鏇遞鹹鬱遞鬱範願鏇(憲艱糧願獵鬱憲蓋獵齋) = 願襯簾網淵築齋築願壓餘鹽鬱築鏇鏇壓衊糧膚 (鹽夢廠艱願築鏇鹽繭鹽 ) 更多	积极	2010-10-15
				DTPw-HBV/Hib vaccine (DTPw-HBV/Hib)	願鏇遞鹹鬱遞鬱範願鏇(憲艱糧願獵鬱憲蓋獵齋) = 願夢齋窪鹽簾齋夢網鑰餘鹽鬱築鏇鏇壓衊糧膚 (鹽夢廠艱願築鏇鹽繭鹽 ) 更多