英芬四联(Diphtheria, tetanus, acellular pertussis, poliomyelitis and Haemophilus influenzae type b conjugate 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

+ [1]

别名

Hib-DTP-acellular vaccine、Hib-DTaP vaccine、Infanrix-Hib

+ [1]

靶点-

作用方式-

作用机制-

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

德国 (1996-10-01),

白喉嗜血杆菌感染破伤风+ [1]

最高研发阶段(中国)无进展

特殊审评-

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关联

3

项与英芬四联相关的临床试验

NCT01449812

/ Completed临床3期

Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) in Healthy Chinese Toddlers

The purpose of this booster study is to evaluate the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. The study will also evaluate the safety and immune response of these subjects to a booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT01086423).

开始日期2011-10-01

申办/合作机构

GSK Plc

NCT01323647

/ Completed临床3期

Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (PoliorixTM) in Healthy Chinese Toddlers

This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study. The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.

开始日期2011-04-25

申办/合作机构

GSK Plc

NCT00412854

/ Completed临床3期

Phase IIIb, Multicentre Study to Assess Safety & Immunogenicity of GSK Biologicals' Combined DTPa/Hib (Infanrix/Hib) Vaccine vs Separate Administration of DTPa (Infanrix) & Hib (Hiberix) Vaccines in Healthy Infants 3,4,&5 Months of Age as Compared With the Separate Administration of DTPa and Hib Vaccines at Different Injection Sites.

This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and immunogenicity.

开始日期2007-01-03

申办/合作机构

GSK Plc

100 项与英芬四联相关的临床结果

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100 项与英芬四联相关的转化医学

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100 项与英芬四联相关的专利（医药）

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7

项与英芬四联相关的文献（医药）

2019-06-01·Contemporary Clinical Trials Communications

Clinical study of safety and immunogenicity of pentavalent DTP-HB-Hib vaccine administered by disposable-syringe jet injector in India

Article

作者: Lalwani, Sanjay ; Ravichandran, Latha ; Bavdekar, Ashish ; Hanumante, Neeta ; Chaudhari, Amol ; Palkar, Sonali ; McGray, Sarah ; Kulkarni, Prasad S ; Malshe, Nandini ; Zehrung, Darin ; Saganic, Laura ; Jarrahian, Courtney ; Sapru, Amita ; Gunale, Bhagwat ; Miller, Tara ; Kawade, Anand ; Kapse, Dhananjay

INTRODUCTIONWe conducted a randomized, observer-blind, non-inferiority, parallel-group clinical study of diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b conjugate (pentavalent) vaccination of infants in India. Goals were to determine whether the seropositivity rate after vaccination via disposable-syringe jet injector (DSJI) was non-inferior to that via needle and syringe (N-S), and to compare the safety of vaccination by the two methods.METHODSHealthy children received a three-dose series of vaccine intramuscularly by DSJI or N-S beginning at 6-8 weeks of age. Immunoglobulin G antibody levels were measured by ELISA at 4-6 weeks after the third dose. The main secondary endpoint was safety, measured as injection site and systemic reactions.DISCUSSIONThe study was stopped early out of caution beyond that specified in the protocol stopping criteria, after the Data Safety Committee noted a higher frequency of injection site reactions, especially moderate and severe, in the DSJI group. As a result, 128 subjects-DSJI group 61; N-S group 67-completed the study, rather than the 340 planned, and the study was not sufficiently powered to compare immunogenicity endpoints for the groups. Descriptive statistics indicate that seropositivity induced by vaccination with the DSJI was similar to that of N-S for all five antigens. Pentavalent vaccine includes whole-cell pertussis vaccine and an aluminum adjuvant, which may have contributed to the higher number of local reactions with the DSJI. The reactions caused no serious or long-term sequelae, and may be more acceptable in other populations or circumstances.US National Institutes of Health clinical trials identifier: NCT02409095.

2015-12-01·BMC Pediatrics4区 · 医学

The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule

4区 · 医学

ArticleOA

作者: Sekartini, Rini ; Sari, Rini Mulia ; Hadinegoro, Sri Rezeki ; Risan, Nelly Amalia ; Bachtiar, Novilia Sjafri ; Tarigan, Rodman ; Gunardi, Hartono ; Satari, Hindra Irawan ; Fadlyana, Eddy ; Tanuwidjaja, Suganda ; Dhamayanti, Meita ; Milanti, Mia ; Rusmil, Kusnandi ; Garheni, Reni ; Prasetio, Dwi ; Soedjatmiko

BACKGROUNDWHO recommended incorporation of Haemophilus influenzae type b (Hib) vaccination into immunization program. Indonesia would adopt Hib as a National Immunization Program in 2013. We aimed at analyzing immunogenicity, safety, and consistency of a new combined DTP-HB-Hib (diphtheria-tetanus-pertussis-Hepatitis B-Haemophilus influenza B) vaccine.METHODSA prospective, randomized, double blind, multicenter, phase III study of Bio Farma DTP-HB-Hib vaccine conducted in Jakarta and Bandung, August 2012 - January 2013. Subjects were divided into three groups with different batch number. Healthy infants 6-11 weeks of age at enrollment were immunized with 3 doses of DTP-HB-Hib vaccine with interval of 4 weeks, after birth dose of hepatitis B vaccine. Blood samples obtained prior to vaccination and 28 days after the third dose. Safety measures recorded until 28 days after each dose.RESULTSOf 600 subjects, 575 (96 %) completed study protocol. After 3 doses, 100.0 and 96.0 % had anti-PRP concentration ≥0.15 and ≥1.0 μg/ml. Anti-diphtheria and anti-tetanus concentration ≥0.01 IU/ml detected in 99.7 and 100.0 %; while concentration ≥0.1 IU/ml achieved in 84.0 and 97.4 %. Protective anti-HBs found in 99.3 %. The pertussis vaccine response rate was 84.9 %. None Serious Adverse events (SAEs) considered related to study vaccine or procedure.CONCLUSIONSThe 3-dose of DTP-HB-Hib was immunogenic, well tolerated and suitable for replacement of licensed-equivalent vaccines based on immunologic and safety profiles.TRIAL REGISTRATIONNCT01986335 - October 30(th) 2013.

2009-07-08·The Cochrane database of systematic reviews

Combined DTP-HBV-HIB vaccine versus separately administered DTP-HBV and HIB vaccines for primary prevention of diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae B (HIB).

Review

作者: Vidal, Liat ; Hellmann, Sarah ; Goldberg, Elad ; Bar-On, Edna S ; Fraser, Abigail ; Leibovici, Leonard

BACKGROUNDAdvantages to combining childhood vaccines include reducing the number of visits, injections and patient discomfort, increasing compliance, and optimizing prevention. The World Health Organization recommends that routine infant immunization programs include a vaccination against Haemophilus influenza type B (HIB) in the combined diphtheria, tetanus, pertussis (DTP)-hepatitis B (HBV) vaccination. The effectiveness and safety of the combined vaccine should be carefully and systematically assessed to ensure their acceptability by the community.OBJECTIVESTo compare the effectiveness of combined DTP-HBV-HIB vaccine with DTP-HBV and HIB vaccinations.SEARCH STRATEGYWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2009, issue 1) which contains the Acute Respiratory Infection Group's Specialized Register; MEDLINE (January 1966 to March 2009) and EMBASE (January 1990 to March 2009).SELECTION CRITERIARandomized or quasi-randomized controlled trials comparing vaccination with any combined DTP-HBV-HIB vaccine, with or without three types of inactivated poliovirus (IPV) or concomitant oral polio vaccine (OPV) in any dose, preparation or time schedule, compared with separate vaccines or placebo, administered to infants aged up to two years.DATA COLLECTION AND ANALYSISTwo review authors independently inspected references identified by the searches and evaluated them against the inclusion criteria, extracted data and assessed the methodological quality of included trials.MAIN RESULTSMeta-analysis was performed to pool the results of 18 studies. There were no data on clinical outcomes for the primary outcome and all studies used immunogenicity and reactogenicity (adverse events). In two immunological responses the combined vaccine achieved lower responses than the separate vaccines for HIB and HBV. Comparison found little heterogeneity. No significant differences in immunogenicity were found for pertussis, diphtheria, polio and tetanus. Serious adverse events were comparable. Minor adverse events were more common in children given the combined vaccine.AUTHORS' CONCLUSIONSWe could not conclude that the immune responses elicited by the combined vaccine were different from, or equivalent to, the separate vaccines. Data for the primary outcome (prevention of disease) were lacking. There was significantly less immunological response for HIB and HBV, and more local reactions in the combined injections. However, these differences rely mostly on one study each. Studies did not use an intention-to-treat analysis and we were uncertain about the risk of bias in many of the studies. These results are therefore inconclusive. Studies addressing clinical end-points whenever possible, using correct methodology and a large enough sample size should be conducted.

100 项与英芬四联相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07BB	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
白喉	德国	GSK Plc	1996-10-01
嗜血杆菌感染	德国	GSK Plc	1996-10-01
破伤风	德国	GSK Plc	1996-10-01
百日咳	德国	GSK Plc	1996-10-01

未上市

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
脊髓灰质炎	临床2期	中国	GSK Plc	2011-04-25

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临床结果

适应症

分期

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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


NCT01449812 (CTgov)	临床3期	白喉 \| 嗜血杆菌感染 \| 百日咳 \| 破伤风	831	Poliorix™+Infanrix+Hib™ (Infanrix+Hib/Poliorix 1 Group)	製齋窪膚餘艱壓鹹壓鬱(簾鏇構鹽鏇鹹簾鑰範鬱) = 構齋網窪獵襯窪獵蓋積選襯艱齋鏇獵壓鏇顧積 (蓋願鬱壓齋網範醖糧醖, 窪窪蓋顧顧壓廠簾糧衊 ~ 鑰構鹽構簾膚廠夢繭襯) 更多	-	2017-04-13
				Poliorix™+Infanrix+Hib™ (Infanrix+Hib/Poliorix 2 Group)	製齋窪膚餘艱壓鹹壓鬱(簾鏇構鹽鏇鹹簾鑰範鬱) = 顧膚鹹觸蓋夢願遞壓衊選襯艱齋鏇獵壓鏇顧積 (蓋願鬱壓齋網範醖糧醖, 鬱憲獵鹹艱鏇築衊蓋艱 ~ 窪遞艱襯觸鏇選衊遞築) 更多
NCT01323647 (CTgov)	临床3期	脊髓灰质炎	957	Poliorix™ vaccine+Infanrix-Hib™ vaccine (Poliorix Group)	簾淵膚衊鏇夢遞襯範糧(夢網齋艱選蓋觸鹽壓築) = 醖餘選積壓積顧鏇製壓醖衊鑰選膚簾繭鹹夢淵 (網廠膚選鹹襯顧壓齋艱, 簾顧願遞構築衊壓餘網 ~ 餘餘齋鬱構鹽遞窪網膚) 更多	-	2016-12-07
				Chinese oral poliovirus vaccine (OPV)+Infanrix-Hib™ vaccine (Control Group)	壓積網鏇窪窪夢鹹壓鹹(構築蓋艱構顧蓋構醖獵) = 鏇遞築鹽糧獵鹽範齋繭獵膚築夢蓋選廠衊遞醖 (壓糧網鏇艱範壓夢顧願, 齋獵艱顧糧窪遞鑰顧醖 ~ 顧簾衊夢鹹襯願鬱觸艱) 更多