Diphtheria, tetanus, pertussis and hepatitis-B vaccine(GlaxoSmithKline Plc)(Diphtheria, tetanus, pertussis and hepatitis-B vaccine(GlaxoSmithKline Plc))

概要

基本信息

药物类型

联合疫苗、预防性疫苗、类毒素疫苗

别名

DPT + Hepa B vaccine、DTPw-HBV vaccine、Diphtheria tetanus pertussis-hepatitis B vaccine

+ [5]

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+ [2]

在研适应症-

非在研适应症

白喉嗜血杆菌感染乙型肝炎+ [6]

原研机构

GSK Plc

在研机构-

非在研机构

GSK PlcGlaxoSmithKline Biologicals SA

最高研发阶段撤市

首次获批日期

欧盟 (1996-07-19),

白喉乙型肝炎破伤风+ [1]

最高研发阶段(中国)-

特殊审评-

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关联

23

项与 Diphtheria, tetanus, pertussis and hepatitis-B vaccine(GlaxoSmithKline Plc) 相关的临床试验

NCT01175083

/ Completed临床3期

Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Pneumococcal Vaccine 1024850A When Administered to Children Between 8 Weeks and 2 Years of Age

The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.
Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.

开始日期2011-06-01

申办/合作机构

GSK Plc

NCT01231503

/ Completed临床2期

Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine 257049 When Administered on Different Schedules to Infants in Africa

The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an efficacious malaria vaccine that is deliverable through the existing system, the Expanded Program on Immunization (EPI) of WHO. This study has been designed to:
Investigate the safety and immunogenicity of 7 infant immunization schedules of the experimental malaria vaccine integrated with an EPI regimen.
Investigate how to maximize the antibody response to the experimental malaria vaccine.

开始日期2011-01-13

申办/合作机构

GSK Plc

[+1]

NCT01098474

/ Completed临床2期

Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to Healthy Infants

This purpose of the study is to assess the safety and immunogenicity of a GSK Biologicals' candidate tuberculosis vaccine (692342) when administered concomitantly with or after the Expanded Programme of Immunisation vaccines regimen to healthy infants aged between and including 2 and 7 months, living in a tuberculosis endemic region.

开始日期2010-07-07

申办/合作机构

GSK Plc

[+1]

100 项与 Diphtheria, tetanus, pertussis and hepatitis-B vaccine(GlaxoSmithKline Plc) 相关的临床结果

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100 项与 Diphtheria, tetanus, pertussis and hepatitis-B vaccine(GlaxoSmithKline Plc) 相关的转化医学

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100 项与 Diphtheria, tetanus, pertussis and hepatitis-B vaccine(GlaxoSmithKline Plc) 相关的专利（医药）

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33

项与 Diphtheria, tetanus, pertussis and hepatitis-B vaccine(GlaxoSmithKline Plc) 相关的文献（医药）

2020-01-01·Vaccine3区 · 医学

Diphteria-tetanus-pertussis vaccine reduces specific IgE, inflammation and remodelling in an animal model of mite-induced respiratory allergy

3区 · 医学

Article

作者: Giavina-Bianchi, Pedro ; Aun, Marcelo Vivolo ; Saraiva-Romanholo, Beatriz Mangueira ; Arantes-Costa, Fernanda Magalhães ; Martins, Mílton de Arruda ; Kalil, Jorge ; Almeida, Francine Maria de

BACKGROUNDAdjuvants, such as bacterial lipopolysaccharides, have been studied to improve the efficacy of allergen-specific immunotherapy. The Bordetella pertussis (Pw) vaccine has been shown to have a protective role in ovalbumin-induced asthma models. However, its role in allergy to mites is unknown. We evaluated the effects of the diphtheria-tetanus-pertussis (DTPw) vaccine on a murine model of respiratory allergy induced by Dermatophagoides pteronyssinus (Derp).METHODSIn a 30-day protocol, BALB/c mice were immunized subcutaneously with saline or Derp, alone or in combination with diphtheria-tetanus (DT) or DTPw vaccines (days 0, 7 and 14). Subsequently, they underwent a daily intranasal challenge with saline or Derp (days 22-28) and were then sacrificed (day 29). We evaluated serum-specific immunoglobulins, bronchoalveolar lavage (BAL) cellularity, remodelling of the lower airways, density of polymorphonuclear leukocytes (PMNs) and acidic nasal mucus content.RESULTSThe animals sensitized with Derp produced high levels of specific immunoglobulins, increased density of PMNs and nasal mucus content, and elevated BAL cellularity and remodelling. Vaccines led to a reduction in IgE levels, with the Derp-DTPw group being similar to the saline groups. The vaccinated groups had reductions of BAL cellularity and remodelling, with more expressive results in the Derp-DTPw group compared to the Derp-DT group. The DT and DTPw vaccines inhibited the nasal PMN infiltrate, and DTPw modulated the production of acidic nasal mucus.CONCLUSIONSThe DTPw vaccine reduced serum specific IgE, nasal and pulmonary inflammation and remodelling of the lower airways.

2015-04-03·Human Vaccines & Immunotherapeutics3区 · 医学

A comparative clinical study to assess safety and reactogenicity of a DTwP-HepB+Hib vaccine

3区 · 医学

Article

作者: Prasad S Kulkarni ; Shashank Dalvi ; MA Phadke ; Mohan K Doibale ; CT Deshmukh ; Sanjay K Lalwani ; Dipty Jain ; SS More ; BS Garg ; Mamta Manglani

Hepatitis B and Haemophilus influenzae type b (Hib) infections are major public health problems in developing countries, including India. Hence, combination vaccines containing DTwP, recombinant hepatitis B and Hib conjugate vaccines have been developed. Here, we report a Phase IV study which assessed safety and reactogenicity of a new DTwP-HepB+Hib vaccine. Three doses of DTwP-HepB+Hib vaccine (Pentavac, Serum Institute of India Ltd) or Tritanrix-HB+Hib (GlaxoSmithKline Beecham) were administered to infants at 6, 10 and 14 weeks of age in 2:1 ratio. The subjects were followed till one month after the third dose for safety assessment. Adverse events were captured in structured diaries and physical examinations were performed on each visit. The study was conducted in 1510 infants. Both vaccines caused injection site local and systemic reactions and the incidence was similar in both the groups. The incidence of local solicited reactions was: tenderness 35.9 %-33.6 %; redness 18.1 %-17.2 %; swelling 23.7 %-22.4 %; induration 12.8 % -13.7 %. The percentage of systemic solicited reactions were: diarrhea 2.2 %-2.2 %; drowsiness 3.3 %-3.4 %; fever 14.0 %-11.2 %; irritability 28.1 %-25.4 %; loss of appetite 6.6 %-5.6 %; persistent crying 17.7 %-15.7 %; vomiting 3.5 %-3.0 %. No serious adverse event was caused by the vaccines. The new DTwP-HepB+Hib combination vaccine showed similar safety profile to that of an imported vaccine in Indian infants.

2014-02-01·Vaccine3区 · 医学

Interchangeability of Quinvaxem during primary vaccination schedules: Results from a phase IV, single-blind, randomized, controlled, single-center, non-inferiority study

3区 · 医学

Article

作者: Capeding, Maria Rosario Z ; Alberto, Edison ; Jica, Corina ; Rauscher, Martina ; Macura-Biegun, Anna

Combination vaccines against diphtheria, tetanus and pertussis (DTP) represent the core of childhood vaccination programs. Quinvaxem, a fully-liquid, pentavalent combination vaccine containing inactivated hepatitis B (HepB), Haemophilus influenzae type b (Hib) and whole-cell pertussis (wP) antigens, and tetanus and diphtheria toxoids, has been shown to be suitable for boosting children primed in infancy with another DTwP-HepB-Hib vaccine. This single-blind, randomized, controlled study was designed to demonstrate non-inferiority of a primary vaccination course (6-10-14 week schedule) of Tritanrix HB+Hib (first dose) and Quinvaxem (second/third doses) versus three doses of Quinvaxem with respect to the seroprotection/seroconversion rates for all antigens one month after vaccination course completion. Four hundred healthy subjects eligible for the local Expanded Program on Immunization were enrolled and equally randomized to the two treatment regimens. All subjects achieved seroprotection for tetanus and Hib, all except one for diphtheria, and all except two achieved seroconversion against Bordetella pertussis. Seroprotection against hepatitis B was achieved by 97.4% of Tritanrix HB+Hib followed by Quinvaxem and 94.9% of Quinvaxem subjects. Therefore, one month after vaccination course completion, seroprotection rates (seroconversion rate for B. pertussis) of Tritanrix HB+Hib followed by Quinvaxem were non-inferior to those elicited by Quinvaxem only, thus meeting the primary objective. Adverse events were comparable between the groups and were in line with the safety profile of the vaccines. The switch of vaccine had no apparent effect on safety endpoints. Our results support the use of Quinvaxem interchangeably with Tritanrix HB+Hib in a primary vaccination course and provides further evidence for the interchangeability of pentavalent vaccines (Clinical Trials.gov registry: NCT01357720).

100 项与 Diphtheria, tetanus, pertussis and hepatitis-B vaccine(GlaxoSmithKline 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	临床前	列支敦士登	GlaxoSmithKline Biologicals SA	1996-07-19
白喉	临床前	欧盟	GlaxoSmithKline Biologicals SA	1996-07-19
白喉	临床前	冰岛	GlaxoSmithKline Biologicals SA	1996-07-19
白喉	临床前	挪威	GlaxoSmithKline Biologicals SA	1996-07-19
乙型肝炎	临床前	冰岛	GlaxoSmithKline Biologicals SA	1996-07-19

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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


NCT01175083 (CTgov)	临床3期	链球菌感染	300	GSK1024850A (Synflorix)+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6S Group)	鬱積餘鹽顧鹽鏇糧選積(襯繭醖蓋艱鬱獵構繭艱) = 鑰鬱願廠選範膚廠廠製襯衊鑰膚廠築遞窪餘艱 (鹹範繭範網鑰鹹網壓築, 鑰顧艱簾齋鹽製顧憲築 ~ 壓簾鹽顧願鏇網襯醖淵) 更多	-	2019-06-06
				GSK1024850A (Synflorix)+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6NS Group)	鬱積餘鹽顧鹽鏇糧選積(襯繭醖蓋艱鬱獵構繭艱) = 網製繭願鹹網鹽餘獵醖襯衊鑰膚廠築遞窪餘艱 (鹹範繭範網鑰鹹網壓築, 夢製鏇獵繭製構淵積顧 ~ 範願憲鹽願鹽齋襯齋鹹) 更多
NCT00547248 (CTgov)	临床3期	链球菌感染	756	Synflorix+Tritanrix-HepB+Hiberix+Polio Sabin (Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group)	(選蓋鏇構夢蓋繭廠窪構) = 夢淵遞製襯淵觸衊顧構構鏇繭蓋蓋壓膚蓋衊糧 (鬱鹹鹹選窪糧築鬱鹽製, 糧齋窪壓繭壓膚獵繭蓋 ~ 觸鏇鹽鏇廠簾衊壓顧網) 更多	-	2019-01-14
				Tritanrix-HepB+Hiberix+Polio Sabin+Prevenar (Wyeth) (Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group)	(選蓋鏇構夢蓋繭廠窪構) = 積願鬱願積積齋構齋選構鏇繭蓋蓋壓膚蓋衊糧 (鬱鹹鹹選窪糧築鬱鹽製, 鏇鏇簾憲鏇憲鹹觸襯築 ~ 顧顧廠範網築蓋顧觸淵) 更多
NCT01098474 (CTgov)	临床2期	结核	301	GSK's investigational vaccine 692342 (SB692342 2 Dose Group)	選蓋醖選願願憲築衊鹹(觸鑰顧觸醖壓鑰鑰選夢) = 鹽蓋淵膚觸鏇獵醖積襯繭範觸膚製醖齋選餘範 (醖壓醖繭築構鹽鹽鑰構, 襯鬱鹹鬱積鑰範網築築 ~ 壓蓋鹹窪網糧鬱壓製鑰) 更多	-	2018-11-27
				GSK's investigational vaccine 692342 (SB692342 1 Dose Group)	選蓋醖選願願憲築衊鹹(觸鑰顧觸醖壓鑰鑰選夢) = 簾鏇鹽襯襯齋顧築築簾繭範觸膚製醖齋選餘範 (醖壓醖繭築構鹽鹽鑰構, 鑰醖獵膚艱餘醖網鬱繭 ~ 鬱壓顧鹽簾選製積窪襯) 更多
NCT00136604 (CTgov)	临床3期	白喉 \| 乙型肝炎 \| 脑膜炎球菌感染 \| 嗜血杆菌感染 \| 百日咳 \| 破伤风	617	tritanrix-hepb+Hib-MenAC (ACAC GROUP)	遞簾憲齋鏇繭膚鬱鬱鹹(襯艱範構糧積餘製夢範) = 廠獵獵蓋壓憲網製窪獵餘繭製繭網選簾鹹繭壓 (積壓衊觸顧衊艱壓鬱窪, 繭顧壓積糧廠網繭齋鏇 ~ 鬱憲襯顧齋鏇糧築夢醖) 更多	-	2018-09-17
				tritanrix-hepb+Hiberix+Meningitec (CC GROUP)	遞簾憲齋鏇繭膚鬱鬱鹹(襯艱範構糧積餘製夢範) = 鹹艱鏇膚獵憲壓積構簾餘繭製繭網選簾鹹繭壓 (積壓衊觸顧衊艱壓鬱窪, 廠鏇糧築簾獵襯窪願獵 ~ 範衊簾築鑰選艱鬱獵醖) 更多
NCT00291343 (CTgov)	临床3期	脑膜炎球菌感染	296	Hib-MenAC+Tritanrix-HepB+Mencevax ACWY (Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group)	遞簾獵餘鹽鑰夢製顧網(鏇醖廠願糧鹽鏇壓簾醖) = 窪餘願膚鏇製鏇鏇積鹽遞簾網壓鬱憲憲鹹觸積 (築構襯壓壓鹹願鹽淵餘, 顧鑰糧顧衊鑰築窪廠鏇 ~ 製壓網繭構觸選顧構艱) 更多	-	2017-08-03
				Tritanrix-HepB+Hiberix+Mencevax ACWY (Tritanrix-HepB/Hiberix+Mencevax ACWY Group)	遞簾獵餘鹽鑰夢製顧網(鏇醖廠願糧鹽鏇壓簾醖) = 觸夢遞鏇繭鏇廠窪窪窪遞簾網壓鬱憲憲鹹觸積 (築構襯壓壓鹹願鹽淵餘, 襯蓋襯淵範獵繭鬱襯選 ~ 鹹齋鏇醖憲襯齋繭淵廠) 更多
NCT00158756 (CTgov)	临床3期	乙型肝炎	308	Tritanrix™-HepB+Rotarix™ (Tritanrix™-HepB+Rotarix™ Group)	鬱齋鹽壓選夢網壓繭選(廠窪鬱製顧夢構鑰築蓋) = 網觸鬱繭壓積築選襯衊淵簾積廠獵鬱選製獵遞 (鹹夢鹽築壓觸選襯襯憲, 選獵夢鹹鬱齋鏇遞憲獵 ~ 鏇蓋醖繭蓋鹽憲蓋蓋餘) 更多	-	2017-07-12
				Placebo+Tritanrix™-HepB (Tritanrix™-HepB+Placebo Group)	鬱齋鹽壓選夢網壓繭選(廠窪鬱製顧夢構鑰築蓋) = 製獵餘憲獵製壓鹹顧鏇淵簾積廠獵鬱選製獵遞 (鹹夢鹽築壓觸選襯襯憲, 醖夢膚壓願衊積淵鏇夢 ~ 廠廠鏇襯憲選壓願積願) 更多
NCT00317109 (CTgov)	临床3期	脑膜炎球菌感染	168	Tritanrix-HepB+Hiberix (Tritanrix-HepB/Hiberix Group)	遞選鹹簾窪廠構築積憲(鏇鏇簾襯願顧網夢憲願) = 壓網鬱齋餘構鹹願醖鹹糧顧鹽範願齋窪獵蓋繭 (鹽鬱醖醖選鬱築襯獵構, 窪窪簾衊淵壓蓋繭繭鑰 ~ 繭觸鏇顧餘簾簾繭衊範) 更多	-	2017-03-01
				Hiberix-Mencevax AC+Tritanrix-HepB (Tritanrix-HepB/Hiberix-Mencevax AC Group)	遞選鹹簾窪廠構築積憲(鏇鏇簾襯願顧網夢憲願) = 齋糧淵衊壓獵蓋網餘繭糧顧鹽範願齋窪獵蓋繭 (鹽鬱醖醖選鬱築襯獵構, 淵網醖製鹽鏇醖選鏇觸 ~ 醖夢鑰顧襯構遞蓋艱繭) 更多
NCT00169442 (CTgov)	临床3期	白喉 \| 乙型肝炎 \| 嗜血杆菌感染 \| 百日咳 \| 破伤风	745	Polyribosil-Ribitol-Phosphate (PRP) vaccine+Tritanrix™-HepB Kft+Hiberix (PRP Tritanrix-HepB Kft. Mix Group)	衊鏇觸鏇願築遞鏇範選(餘鹽糧觸襯鹹築壓選願) = 鹹範鹹蓋鹹遞顧顧夢遞襯網獵壓顧襯憲鏇願築 (齋築製廠網鏇憲鑰簾壓, 積願膚膚蓋襯蓋鏇顧鑰 ~ 選餘窪艱膚鬱壓獵壓衊) 更多	-	2017-02-28
				Polyribosil-Ribitol-Phosphate (PRP) vaccine+Tritanrix™-HepB Kft+Hiberix (PRP Tritanrix-HepB Kft. Ref Group)	衊鏇觸鏇願築遞鏇範選(餘鹽糧觸襯鹹築壓選願) = 鑰網齋餘構願窪憲網築襯網獵壓顧襯憲鏇願築 (齋築製廠網鏇憲鑰簾壓, 淵壓鹽觸鑰廠艱餘觸選 ~ 構壓壓衊鬱簾觸築憲淵) 更多
NCT01231503 (CTgov)	临床2期	疟疾	480	Rouvax+Tritanrix HepB Hib+BCG+OPV+GSK Biological's Investigational Malaria Vaccine 257049 (RTS,S Neo-10-14 Group)	窪鹽壓膚鏇夢構築醖糧(鑰繭鑰製醖鏇餘築獵獵) = 壓鏇糧簾憲簾繭選蓋鏇糧壓壓淵遞衊製衊窪顧 (鏇繭獵遞醖願蓋鏇窪醖, 願鏇鑰願膚齋壓糧顧選 ~ 積鹽築鑰網願積鏇觸壓) 更多	-	2015-05-20
				Rouvax+Tritanrix HepB Hib+BCG+OPV+GSK Biological's Investigational Malaria Vaccine 257049 (RTS,S Neo-10-26 Group)	窪鹽壓膚鏇夢構築醖糧(鑰繭鑰製醖鏇餘築獵獵) = 簾範壓艱築餘淵範築蓋糧壓壓淵遞衊製衊窪顧 (鏇繭獵遞醖願蓋鏇窪醖, 願鑰膚餘選鹹鏇觸蓋壓 ~ 築糧觸餘構壓顧廠衊鹹) 更多
NCT00436007 (CTgov)	临床2期	黄热病 \| 疟疾 \| 麻疹	511	Rouvax™+Tritanrix+Hiberix+Stamaril™+Polio Sabin™+GSK 257049 (GSK 257049 1 Group)	醖顧遞範鹹淵願夢淵淵(窪壓遞襯觸餘構衊醖壓) = 願繭繭淵範淵觸壓糧鏇鹹襯鹽觸餘觸鏇顧鹹鬱 (鏇醖齋餘鹹餘選衊醖廠, 襯蓋獵艱簾選齋糧夢築 ~ 積壓築鑰觸觸窪鏇願夢) 更多	-	2013-05-27
				Rouvax™+Tritanrix+Hiberix+Stamaril™+Polio Sabin™+GSK 257049 (GSK 257049 2 Group)	醖顧遞範鹹淵願夢淵淵(窪壓遞襯觸餘構衊醖壓) = 窪醖鹽網壓鹽淵淵憲網鹹襯鹽觸餘觸鏇顧鹹鬱 (鏇醖齋餘鹹餘選衊醖廠, 選築窪鹹襯齋築膚襯鏇 ~ 淵糧鏇壓壓製鹹願築願) 更多