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-

作用方式

刺激剂

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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10

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

2012-05-01·Human Vaccines & Immunotherapeutics3区 · 医学

Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal non-typeableHaemophilus influenzaeprotein D conjugate vaccine (PHiD-CV) when co-administered with the DTPw-HBV/Hib vaccine in Indian infants: a single-blind, randomized, controlled study

3区 · 医学

Article

作者: Sukanta Chatterjee ; Shailesh Mehta ; Dorota Borys ; Sanjay Lalwani ; Jugesh Chhatwal ; Valsan P. Verghese ; Marta Moreira ; Fakrudeen Shafi ; Lode Schuerman

In India, pneumococcal diseases are major causes of child mortality, and effective vaccines against Streptococcus pneumoniae are needed. This single-blind, randomized study assessed the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Hemophilus influenzae (NTHi) protein D conjugate vaccine (PHiD-CV) co-administered with DTPw-HBV/Hib in Indian infants as 3-dose primary vaccination course. A total of 360 infants were randomized (2:1) to receive either PHiD-CV co-administered with DTPw-HBV/Hib (PHiD-CV group) or a Hib vaccine co-administered with DTPw-HBV (control group) at 6, 10, and 14 weeks of age. For each vaccine pneumococcal serotype, the percentage of infants in the PHiD-CV group with antibody concentrations ≥ 0.2 µg/mL one month after the third vaccine dose was at least 98.3%, except for serotypes 6B (77.7%) and 23F (89.5%), and opsonophagocytic activity titers ≥ 8 were measured in at least 95.7% of infants, except for serotypes 1 (90.5%) and 6B (84.5%). In addition, all the infants in the PHiD-CV group were seroprotected against diphtheria, tetanus, Hib, and hepatitis B or seropositive for antibodies against pertussis and NTHi protein D (except one infant). Incidences of solicited local and general symptoms were comparable between groups, except for fever (axillary temperature ≥ 37.5°C), which seemed to occur more frequently in the PHiD-CV group. In conclusion, PHiD-CV was shown to be immunogenic and well-tolerated when co-administered with DTPw-HBV/Hib in Indian infants.

2010-12-01·BMC Infectious Diseases3区 · 医学

The immunogenicity and safety of a reduced PRP-content DTPw-HBV/Hib vaccine when administered according to the accelerated EPI schedule

3区 · 医学

ArticleOA

作者: Sylvan J Rego ; Sukanta Chatterjee ; Jeanne-Marie Jacquet ; Sanjoy K Datta ; Alix Collard ; BD Bhatia ; Fulton D'Souza

AbstractBackgroundCombination vaccines improve coverage, compliance and effectively introduce new antigens to mass vaccination programmes. This was a phase III, observer-blind, randomized study of GSK Biologicals diphtheria-tetanus-whole cell pertussis vaccine combined with hepatitis B and Haemophilus influenzae type b vaccines, containing a reduced amount of polyribosyl-ribitol-phosphate (PRP) and a DTPw component manufactured at a different site (DTPw-HBV/Hib2.5 [Kft]). The primary aim of this study was to demonstrate that DTPw-HBV/Hib2.5 [Kft] was not inferior to the licensed DTPw-HBV/Hib (Tritanrix(tm)-HepB/Hiberix(tm)) vaccine or the DTPw-HBV/Hib2.5 vaccine, also containing a reduced amount of PRP, with respect to the immune response to the PRP antigen, when administered to healthy infants, according to the Expanded Programme for Immunization (EPI) schedule at 6, 10 and 14 weeks of age.Methods299 healthy infants were randomised to receive either DTPw-HBV/Hib2.5 [Kft] DTPw-HBV/Hib2.5 or DTPw-HBV/Hib according to the 6-10-14 week EPI schedule. Blood samples were analysed prior to the first dose of study vaccine and one month after the third vaccine dose for the analysis of immune responses. Solicited local and general symptoms such as pain, redness and swelling at the injection site and drowsiness and fever, unsolicited symptoms (defined as any additional adverse event) and serious adverse events (SAEs) were recorded up to 20 weeks of age.ResultsOne month after the third vaccine dose, 100% of subjects receiving DTPw-HBV/Hib2.5 [Kft] or DTPw-HBV/Hib and 98.8% of subjects receiving DTPw-HBV/Hib2.5 vaccine had seroprotective levels of anti-PRP antibodies (defined as anti-PRP antibody concentration ≥0.15 μg/ml). Seroprotective antibody concentrations were attained in over 98.9% of subjects for diphtheria, tetanus and hepatitis B. The vaccine response rate to pertussis antigen was at least 97.8% in each group. Overall, the DTPw-HBV/Hib2.5 [Kft] vaccine was well tolerated in healthy infants; no SAEs were reported in any group.ConclusionsThe DTPw-HBV/Hib2.5 [Kft] vaccine was immunogenic and well-tolerated when administered according to the EPI schedule to Indian infants.Trial registrationhttp://www.clinicaltrials.gov NCT00473668

2010-12-01·BMC Infectious Diseases3区 · 医学

Primary and booster vaccination in Latin American children with a DTPw-HBV/Hib combination: a randomized controlled trial

3区 · 医学

ArticleOA

作者: Javier Casellas ; Katia Abarca ; Miguel Tregnaghi ; Jeanne-Marie Jacquet ; Alix Collard ; Inge Lefevre ; Angela Gentile ; Felix Espinoza

AbstractBackgroundDiphtheria-tetanus-whole-cell pertussis (DTPw)-based combination vaccines are an attractive option to rapidly achieve high coverage and protection against other important pathogens, such as hepatitis B virus (HBV) and Haemophilus influenzae type B (Hib). To ensure adequate antigen supply, GlaxoSmithKline Biologicals has introduced a new DTPw antigen source and developed a new DTPw-HBV/Hib combination vaccine containing a reduced amount of Hib polyribosylribitol phosphate (PRP). This study was undertaken to compare the immunogenicity and reactogenicity of this new DTPw-HBV/Hib vaccine with a licensed DTPw-HBV/Hib vaccine (Tritanrix™-HBV/Hib).MethodsThis was a randomized, partially-blind, multicenter study in three countries in Latin America (Argentina, Chile and Nicaragua). Healthy children received either the new DTPw-HBV/Hib vaccine (1 of 3 lots; n = 439; double-blind) or Tritanrix™-HBV/Hib (n = 146; single-blind) co-administered with oral poliovirus vaccine (OPV) at 2, 4 and 6 months, with a booster dose at 18-24 months.ResultsOne month after the end of the 3-dose primary vaccination course, the new DTPw-HBV/Hib vaccine was non-inferior to Tritanrix™-HBV/Hib in terms of seroprotection/vaccine response rates for all component antigens; ≥97.3% and ≥93.9% of subjects in the two groups, respectively, had seroprotective levels of antibodies against diphtheria, tetanus, hepatitis B and Hib and a vaccine response to the pertussis component. Persistence of antibodies against all vaccine antigens was comparable between groups, with marked increases in all antibody concentrations after booster administration in both groups. Both vaccines were generally well-tolerated as primary and booster doses.ConclusionsResults confirm the suitability of this new DTPw-HBV/Hib vaccine comprising antigens from a new source and a reduced PRP content for inclusion into routine childhood vaccination programs.Trial registrationhttp://www.clinicaltrials.gov NCT00332566

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	阿根廷	GSK Plc	2006-06-01
百日咳	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™)	築壓衊鏇構夢壓獵憲夢(憲糧選艱觸築壓構窪構) = 壓選簾顧築構襯鑰餘網繭蓋製獵遞選廠觸艱鏇 (積選淵範顧構顧淵壓繭, 構醖鬱醖願獵夢築網壓 ~ 顧鹹夢襯衊襯鏇選憲鬱) 更多	-	2017-10-27
				GSK Biologicals' Polio Sabin™+GSK Biologicals' Zilbrix™ Hib (Zilbrix™ Hib + Polio Sabin™)	築壓衊鏇構夢壓獵憲夢(憲糧選艱觸築壓構窪構) = 鹹遞廠齋獵衊築襯憲膚繭蓋製獵遞選廠觸艱鏇 (積選淵範顧構顧淵壓繭, 齋壓積廠壓齋製簾選鹹 ~ 選襯顧窪蓋蓋鬱範衊觸) 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)	獵襯憲襯淵網鑰願選網(膚網顧鏇襯網網壓淵構) = 願積構簾糧選衊鏇簾衊夢顧觸鏇淵蓋淵膚網廠 (餘壓壓艱積製顧選憲蓋, 鏇積鹽艱鹹衊獵壓繭窪 ~ 繭範遞築憲廠窪齋鑰選) 更多	-	2017-08-18
				Tritanrix™-HepB+Hiberix™ (Tritanrix-HepB/Hiberix LD Group)	獵襯憲襯淵網鑰願選網(膚網顧鏇襯網網壓淵構) = 鏇齋鹽齋齋醖糧鬱糧淵夢顧觸鏇淵蓋淵膚網廠 (餘壓壓艱積製顧選憲蓋, 築鹹積選鹽醖窪蓋鹹餘 ~ 衊築夢獵遞簾鏇餘齋築) 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])	餘繭製廠顧鏇鹽觸構壓(膚顧糧窪鹹窪鑰鏇淵憲) = 積窪獵鹽簾窪顧鹽鹹憲構構鏇淵簾鹹鬱鏇構夢 (鑰顧顧選鹹構選齋壓齋 ) 更多	积极	2010-10-15
				DTPw-HBV/Hib vaccine (DTPw-HBV/Hib)	餘繭製廠顧鏇鹽觸構壓(膚顧糧窪鹹窪鑰鏇淵憲) = 簾繭鏇鹽齋膚餘顧憲齋構構鏇淵簾鹹鬱鏇構夢 (鑰顧顧選鹹構選齋壓齋 ) 更多