b型流感嗜血杆菌结合疫苗(Sanofi)(Haemophilus b conjugate vaccine(Sanofi)) - 在研适应症：嗜血杆菌感染，脑膜炎球菌感染_专利_临床

概要

基本信息

药物类型

预防性疫苗、类毒素疫苗、结合疫苗

别名

Haemophilus influenzae type b conjugate vaccine、Haemophilus influenzae type b conjugate vaccine (Sanofi)、Haemophilus type b conjugate vaccine

+ [9]

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Sanofi Pasteur SASanofi KK

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

美国 (2000-02-04),

嗜血杆菌感染

最高研发阶段(中国)批准上市

特殊审评-

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关联

12

项与 b型流感嗜血杆菌结合疫苗(Sanofi) 相关的临床试验

NCT03630705

/ Completed临床3期

Safety and Immunogenicity of a 3-Dose Schedule of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

Primary Objective:
To describe the vaccine seroprotection (antibody titer greater than or equal to [>=] 1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine or Menveo® measured by serum bactericidal assay using human complement (hSBA), for Groups 1 and 2 when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico.
To describe the vaccine seroprotection (antibody titer >=1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine measured by hSBA, for Group 3, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in the Russian Federation.
Secondary Objective:
To describe hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y, and W) 30 days after the last vaccination of the infant series, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico and Russian Federation (RF).
To describe immunogenicity profile of routine pediatric vaccines when administered concomitantly with MenACYW Conjugate vaccine or Menveo®; or when administered alone.
To describe hSBA antibody responses against meningococcal serogroups A, C, Y, and W when MenACYW Conjugate vaccine and Menveo® are administered concomitantly with routine pediatric vaccines in Mexico and RF.
To describe antibody titers to the antigens present in MenACYW Conjugate vaccine and Menveo®, before the first vaccination and 30 days after the last vaccination of the infant series and in the second year of life, when administered concomitantly with routine pediatric vaccines in a subset of participants in Mexico and RF.

开始日期2018-10-17

申办/合作机构

Sanofi Pasteur SA

NCT03691610

/ Completed临床3期

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age.
The secondary objectives of the study are:
* To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age.
* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®.
* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®.
* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.

开始日期2018-10-04

申办/合作机构

Sanofi Pasteur SA

NCT01578070

/ Completed临床1/2期

A Single-centre Study Evaluating the Safety of ViscoGel® and Its Safety and Efficacy as an Adjuvant in Act-HIB® Vaccine Administered by Intramuscular Injection to Healthy Volunteers in a Single-blind Randomised, Parallel-group Design

The purpose of this study is to show that ViscoGel® is safe when administrated alone and as an adjuvant together with Act-HIB® vaccine in healthy volunteers and to evaluate the quantitative and qualitative effect on the immune response.

开始日期2012-03-01

申办/合作机构

Viscogel AB

[+2]

100 项与 b型流感嗜血杆菌结合疫苗(Sanofi) 相关的临床结果

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100 项与 b型流感嗜血杆菌结合疫苗(Sanofi) 相关的转化医学

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100 项与 b型流感嗜血杆菌结合疫苗(Sanofi) 相关的专利（医药）

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274

项与 b型流感嗜血杆菌结合疫苗(Sanofi) 相关的文献（医药）

2024-11-10·Cureus

Managing Epiglottitis in Adults: A Comprehensive Case Study

Article

作者: Anasi, Ayman ; Mayer, Brian ; Ahmed, Imtiaz ; Sadeghi, Nima ; McDermott, Jamie

Epiglottitis is an inflammatory condition involving the epiglottis and surrounding tissues. While it can develop at any age, it was traditionally more common in children, largely due to infections with Haemophilus influenzae type B (Hib). Since the introduction of the Hib vaccine, the incidence in children has significantly decreased, while cases in adults have become more prevalent. We present here the case of a 44-year-old male who presented to the emergency department with a one-day history of throat pain. He reported throat discomfort and pain exacerbated by swallowing and phonation that began one day prior after taking a dose of azithromycin. X-ray and CT imaging revealed inflammation and swelling of the epiglottis (thumbprint sign) with near-complete airway obstruction. Despite the absence of severe respiratory distress, the patient was intubated, differing from recommendations in previous studies. This case emphasizes the importance of developing standardized treatment protocols for acute epiglottitis in adults, particularly regarding airway management and minimizing unnecessary imaging.

2024-08-01·Infectious Disorders - Drug Targets

Efficacy and Prolonged Safety of Haemophilus influenzae Type b Conjugate Vaccines

Review

作者: Mukherjee, Sayali ; Tripathi, Nishita

Objective::The purpose of this study was to find data proving the influence of the Haemophilus influenzae type b (Hib) conjugate vaccination on the frequency of invasive Hib illness.Methodology::A systematic literature search was conducted on the PubMed database to identify peerreviewed publications pertaining to the epidemiology of Haemophilus influenzae meningitis, both before and after the introduction of Haemophilus influenzae type b (Hib) conjugate vaccines. The search query employed a combination of relevant keywords, including "invasive," "Haemophilus," "influenzae," "meningitis," and specific serotype b (Hib). Additionally, terms related to epidemiology, burden, risk factors, impact, Hib vaccine, Hib conjugate vaccine, combination vaccine, vaccine production, efficacy, immunisation coverage, surveillance, review, clinical aspects, outcomes, and various age groups (adults and children) were incorporated.Result::The search encompassed articles published till now. Subsequently, relevant research papers concerning Haemophilus influenzae meningitis were subjected to a comprehensive review and analysis.Conclusion::The Hib conjugate vaccination has shown to be extremely effective when administered to the entire population. However, changes to the immunisation protocol appear to be required in order to effectively manage invasive Hib illness.

2024-04-01·Vaccine

Immunogenicity and safety of adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain)-Haemophilus type b conjugate combined vaccine (DPT-IPV-Hib) in healthy Japanese Infants ≥ 2 and < 43 months of Age: A phase III, multicenter, active controlled, assessor-blinded, randomized, parallel-group study

Article

作者: Matsuda, Keiko ; Hasegawa, Masumi ; Tamai, Hoshio ; Nakano, Takashi ; Endo, Mai

OBJECTIVEThis study investigated the immunogenicity and safety of a pentavalent vaccine Gobik (DPT-IPV-Haemophilus influenzae type b [Hib]) in healthy Japanese infants aged ≥ 2 and < 43 months using a concomitant vaccination with ActHIB® (Hib) and Tetrabik (DPT-IPV) as a comparator.METHODSThis study was conducted as a phase 3, multicenter, active controlled, assessor-blinded, randomized, parallel-group study. Participants received a total of 4 subcutaneous doses (3 primary immunization doses and a booster dose) of either the experimental drug (DPT-IPV-Hib) or the active comparator (Hib + DPT-IPV). The primary endpoints were the anti-PRP antibody prevalence rate with ≥ 1 μg/mL, and the antibody prevalence rates against pertussis, diphtheria toxin, tetanus toxin, and attenuated poliovirus after the primary immunization.RESULTSIn 267 randomized participants (133 in the DPT-IPV-Hib group and 134 in the Hib + DPT-IPV group), the antibody prevalence rates after the primary immunization in both groups were 100.0 % and 88.7 % for anti-PRP antibody with ≥ 1 μg/mL, 99.2 % and 98.5 % against diphtheria toxin, and 100.0 % and 99.2 % against tetanus toxin, respectively. The antibody prevalence rates against pertussis and attenuated poliovirus were 100.0 % in both groups. The non-inferiority of the DPT-IPV-Hib group to the Hib + DPT-IPV group was verified for all measured antibodies. In both groups, all the GMTs of antibodies after the primary immunization were higher than those before the first dose, and those after the booster dose were higher than those after the primary immunization. No safety issues were identified.CONCLUSIONA single-agent Gobik, the first DPT-IPV-Hib pentavalent vaccine approved in Japan, was confirmed to simultaneously provide primary and booster immunizations against Hib infection, pertussis, diphtheria, tetanus, and poliomyelitis and to have a preventive effect and safety comparable to concomitant vaccination with Hib (ActHIB®) and DPT-IPV quadrivalent vaccine (Tetrabik).

2

项与 b型流感嗜血杆菌结合疫苗(Sanofi) 相关的新闻（医药）

2024-07-05

·蒲公英Ouryao

药典委：三个生物制品标准草案公示

来源：国家药典委编辑：wangxinglai2004 2024年07月05日，国家药典委发布了3个生物制品标准公示，具体为3404免疫电泳法国家药品标准、公示期2个月，b型流感嗜血杆菌结合疫苗国家药品标准、公示期2个月，A群C群脑膜炎球菌多糖结合疫苗国家药品标准、公示期2个月。 01 3404免疫电泳法国家药品标准我委拟修订通则3404免疫电泳法国家药品标准，标准编号：《中国药典》2020年版。为确保标准的科学性、合理性和适用性，现将拟修订的通则3404免疫电泳法国家药品标准公示征求社会各界意见（详见附件）。公示期自发布之日起二个月。请认真研核，若有异议，请及时在线反馈，并附相关说明、实验数据和联系方式。来函需打印后加盖公章，个人来函需打印后本人签名，并邮寄至我委通讯地址。公示期满未回复意见即视为对公示标准草案无异议。联系人：曹琰赵雄电话：010-67079595 通信地址：北京市东城区法华南里11号楼国家药典委员会办公室邮编：100061 02 b型流感嗜血杆菌结合疫苗我委拟修订b型流感嗜血杆菌结合疫苗国家药品标准，标准编号：《中国药典》2020年版三部。为确保标准的科学性、合理性和适用性，现将拟修订的b型流感嗜血杆菌结合疫苗国家药品标准公示征求社会各界意见（详见附件）。公示期自发布之日起两个月。请认真研核，若有异议，请及时在线反馈，并附相关说明、实验数据和联系方式。来函需打印后加盖公章，个人来函需打印后本人签名，并邮寄至我委通讯地址。公示期满未回复意见即视为对公示标准草案无异议。联系人：王晓娟电话：010-67079563 通信地址：北京市东城区法华南里11号楼国家药典委员会办公室邮编：100061 03 A群C群脑膜炎球菌多糖结合疫苗我委拟修订A群C群脑膜炎球菌多糖结合疫苗国家药品标准，标准编号：《中国药典》2020年版三部。为确保标准的科学性、合理性和适用性，现将拟修订的A群C群脑膜炎球菌多糖结合疫苗国家药品标准公示征求社会各界意见（详见附件）。公示期自发布之日起两个月。请认真研核，若有异议，请及时在线反馈，并附相关说明、实验数据和联系方式。来函需打印后加盖公章，个人来函需打印后本人签名，并邮寄至我委通讯地址。公示期满未回复意见即视为对公示标准草案无异议。联系人：王晓娟电话：010-67079563 通信地址：北京市东城区法华南里11号楼国家药典委员会办公室邮编：100061

疫苗

2023-05-04

·国家药品监督管理局政务服务门户

2023年05月04日药品批准证明文件送达信息发布

2022年11月1日起，行政相对人可登录网上办事大厅的法人空间查看电子证照，按照相关提示自行打印。序号受理号药品名称申请人批准文号批准日期1CYHB2250128国盐酸丁螺环酮片江苏恩华药业股份有限公司————2023年04月27日2JYSB2200138国重组带状疱疹疫苗(CHO细胞)葛兰素史克（中国）投资有限公司————2023年04月27日3JYSB2200193国b型流感嗜血杆菌结合疫苗深圳赛诺菲巴斯德生物制品有限公司————2023年04月27日

疫苗

100 项与 b型流感嗜血杆菌结合疫苗(Sanofi) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07AG01	-

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
嗜血杆菌感染	美国	Sanofi Pasteur SA	2000-02-04

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
脑膜炎球菌感染	临床3期	美国	Sanofi Pasteur SA	2018-10-04
脑膜炎球菌感染	临床3期	波多黎各	Sanofi Pasteur SA	2018-10-04
白喉	药物发现	美国	Sanofi Pasteur SA	2005-11-01
脊髓灰质炎	药物发现	美国	Sanofi Pasteur SA	2005-11-01
百日咳	药物发现	美国	Sanofi Pasteur SA	2005-11-01

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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


NCT03630705 (MET33, CTgov)	临床3期	脑膜炎球菌感染	525	Rubella Virus Vaccine Live+W) Tetanus Toxoid Conjugate Vaccine+Pneumococcal 13-valent Conjugate Vaccine+Rotavirus Vaccine, Live, Pentavalent (Group 1: MenACYW Conjugate Vaccine (Mexico))	糧鬱範淵觸艱獵構網遞(憲願膚襯鹹糧積鹽襯襯) = 網鹹鏇選選鏇鹽觸淵積鹽築憲獵膚壓簾鹹遞淵 (願鬱觸襯夢壓鹹遞網獵, 觸遞憲壓襯壓構夢鹽鹹 ~ 壓顧願積築醖遞鹽積獵) 更多	-	2023-10-19
				Rubella Virus Vaccine Live+W) Tetanus Toxoid Conjugate Vaccine+Hepatitis B Vaccine+Haemophilus influenza type b Conjugate Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Group 3: MenACYW Conjugate Vaccine (Russian Federation))	獵願選鏇憲鬱艱鬱齋顧(鹹選繭淵壓齋構鹹窪艱) = 製積積壓鏇鬱觸壓醖淵鹹窪築廠淵觸糧製夢獵 (餘蓋觸衊壓淵膚遞簾憲, 夢顧築壓廠繭選窪憲艱 ~ 膚鏇築壓鏇餘鏇淵觸夢) 更多
NCT01411241 (CTgov)	临床3期	严重登革热	720	Pneumococcal vaccine+4 virus+Hib vaccine+DTaP IPV/ (CYD Dengue Vaccine Group 1)	構壓簾簾夢鬱壓蓋鑰遞(衊廠願餘鑰觸憲淵廠獵) = 遞衊鏇選鬱繭顧遞壓築壓艱窪鹽製顧廠鬱窪願 (觸簾膚醖壓積衊齋夢衊, 鑰醖製簾鬱糧遞鹽選衊 ~ 鹹夢網鹽願夢獵餘襯衊) 更多	-	2019-07-29
				Pneumococcal vaccine+4 virus+Hib vaccine+DTaP IPV/ (CYD Dengue Vaccine Group 2)	構壓簾簾夢鬱壓蓋鑰遞(衊廠願餘鑰觸憲淵廠獵) = 鑰網鏇鏇鬱構淵鏇獵窪壓艱窪鹽製顧廠鬱窪願 (觸簾膚醖壓積衊齋夢衊, 繭鬱鏇艱鹹繭廠鑰鹽餘 ~ 襯衊窪壓範願簾廠夢糧) 更多
NCT00129129 (CTgov)	临床2期	脑膜炎 \| 嗜血杆菌感染	756	GSK Biologicals' Haemophilus influenza type b+Prevnar+Pediarix (MenHibrix Group)	選齋夢夢齋憲淵蓋築鬱(鹽壓鏇艱鹽繭衊繭衊範) = 簾淵網繭醖壓範窪蓋範夢餘願積鏇廠範範窪窪 (衊築網艱觸廠窪憲餘鏇, 觸鑰範鬱觸淵膚糧廠築 ~ 餘積衊範顧膚顧壓憲鏇) 更多	-	2013-12-30
				ActHIB+Prevnar+Pediarix (ActHIB Group)	選齋夢夢齋憲淵蓋築鬱(鹽壓鏇艱鹽繭衊繭衊範) = 觸鑰糧積窪齋鑰襯餘蓋夢餘願積鏇廠範範窪窪 (衊築網艱觸廠窪憲餘鏇, 繭鹹鑰獵願簾衊鹹鹹獵 ~ 夢獵製夢繭鏇壓膚構網) 更多
NCT00359983 (CTgov)	临床3期	脑膜炎 \| 嗜血杆菌感染	270	MenHibrix (Hib-MenCY-TT) (MenHibrix 4-dose Group)	築鏇憲製壓網蓋夢鹽憲(構觸遞淵簾窪築齋網繭) = 簾蓋淵積範網獵鑰繭鏇鏇蓋鏇糧觸築鹽糧築襯 (獵淵壓選鹽蓋憲淵鹽襯, 壓願鏇衊鑰壓窪鏇構鹽 ~ 築衊遞範鬱鬱顧範獵網) 更多	-	2012-07-20
				Hib conjugate vaccine (ActHIB) (ActHIB 4-dose Group)	築鏇憲製壓網蓋夢鹽憲(構觸遞淵簾窪築齋網繭) = 鹹廠選積齋觸遞鹽築廠鏇蓋鏇糧觸築鹽糧築襯 (獵淵壓選鹽蓋憲淵鹽襯, 淵鹹淵夢衊襯簾鬱衊鹹 ~ 鹽淵繭製憲選齋醖醖鏇) 更多
NCT00197236 (CTgov)	临床3期	甲型肝炎 \| 白喉 \| 百日咳 \| 破伤风	468	Havrix™ (Havrix Group)	遞鑰艱鹹餘醖繭淵齋夢(襯餘製簾繭願積構衊糧) = 築鏇膚顧範艱簾醖夢壓簾衊獵選廠簾獵構淵構 (選窪廠觸鏇簾齋簾廠糧, 醖獵鏇餘鏇糧鹹網襯構 ~ 鹽獵簾鹹選願夢醖鑰鏇) 更多	-	2009-07-24
				ActHIB™+Infanrix™+Havrix™ (Havrix + Infanrix + ActHIB Group)	遞鑰艱鹹餘醖繭淵齋夢(襯餘製簾繭願積構衊糧) = 襯淵鹹遞繭齋糧觸鏇襯簾衊獵選廠簾獵構淵構 (選窪廠觸鏇簾齋簾廠糧, 積糧遞積顧鏇襯蓋觸廠 ~ 簾廠齋夢願艱鹹憲蓋鑰) 更多