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_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

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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

NCT03537508

/ Completed临床3期

A Phase III, Partially Modified Double-blind, Randomized, Parallel-group, Active-controlled, Multi-center Study to Compare the Immunogenicity and Describe the Safety of MenACYW Conjugate Vaccine and MENVEO® When Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in the United States

The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.

开始日期2018-04-25

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) 相关的专利（医药）

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661

项与 b型流感嗜血杆菌结合疫苗(Sanofi) 相关的文献（医药）

2025-07-01·JOURNAL OF INFECTION

Immune impacts of infant whole-cell and acellular pertussis vaccination on co-administered vaccines

Article

作者: Curtis, Nigel ; McAlister, Sonia ; O'Sullivan, Michael ; Totterdell, James ; McIntyre, Peter B ; Marsh, Julie A ; Jones, Mark ; Richmond, Peter C ; Waddington, Claire S ; Wadia, Ushma ; Estcourt, Marie J ; Gold, Michael ; Wood, Nicholas ; Campbell, Dianne E ; Snelling, Tom ; Perrett, Kirsten P ; Holt, Patrick G ; Pérez Chacón, Gladymar

OBJECTIVES:

We compared the effect of a heterologous wP/aP/aP primary series (hereafter mixed wP/aP) versus a homologous aP/aP/aP primary schedule (hereafter aP-only) on antibody responses to co-administered vaccine antigens in infants and toddlers.

METHODS:

We randomised Australian infants in a 1:1 ratio to receive either a mixed wP/aP schedule (pentavalent diphtheria-tetanus-wP-hepatitis B-Haemophilus influenzae type b; DTwP-HepB-Hib vaccine at 6 weeks old, followed by hexavalent DTaP-inactivated poliovirus vaccine (IPV)-HepB-Hib vaccine at 4 and 6 months old) or aP-only priming doses of hexavalent DTaP-IPV-HepB-Hib vaccine at the same ages. All infants received 13-valent pneumococcal conjugate vaccine (13vPCV) at 6 weeks, 4 and 12 months of age and DTaP-IPV and Hib vaccine boosters at 18 months. We assessed whether the wP/aP schedule is non-inferior to the aP-only schedule for co-administered vaccine antigens (geometric mean ratio [GMR] >2/3).

REGISTRATION:

ACTRN12617000065392p.

RESULTS:

Between March 2018 and January 2020, 150 infants were randomised (75 per arm). Responses to all 13vPCV serotypes and Hib-PRP at 6, 7, 18, and 19 months old, as well as HBsAg at 6 and 7 months old, were non-inferior (>90% probability).

CONCLUSION:

A mixed wP/aP schedule resulted in non-inferior IgG responses to co-administered vaccine antigens compared to the standard aP-only schedule for pertussis primary immunisation.

2025-02-01·JOURNAL OF INFECTION

The need for inclusion of the Hib vaccine in mainland national immunization program in China

Letter

作者: Yu, Dingle ; Yang, Yonghong ; Wang, Yajuan ; Hu, Huili ; Leng, Zhiqin ; Yin, Jun ; Shen, Xuzhuang

2024-12-01·The Lancet regional health. Southeast Asia

Routine immunization against Streptococcus pneumoniae and Haemophilus influenzae type B and antibiotic consumption in India: a dynamic modeling analysis

Article

作者: Parameswaran, Giridara Gopal ; Gleason, Alec C ; Klein, Eili ; Laxminarayan, Ramanan ; Kumar, Chirag K ; Gleason, Alec C. ; Nandi, Arindam ; Summan, Amit ; Kumar, Chirag K.

Background:

Childhood vaccinations can reduce disease burden and associated antibiotic use, in turn reducing the risk of antimicrobial resistance (AMR). We retrospectively estimated the population-level reductions in antibiotic use in India following the introduction of vaccines against Streptococcus pneumoniae and Haemophilius influenzae type B in the national immunization program for children in the mid-2010s and projected future gains to 2028 if vaccination coverage were to be increased.

Methods:

Using IndiaSim, a dynamic agent-based microsimulation model (ABM) for India, we simulated the spread of Streptococcus pneumoniae and Haemophilius influenzae type B (Hib) among children to estimate reductions in antibiotic use under the scenarios of: (i) pneumococcal and Hib vaccine coverage levels equivalent to the national coverage of pentavalent diphtheria-pertussis-tetanus third dose (DPT3) compared to a baseline of no vaccination, and (ii) near-universal (90%) coverage of the vaccines compared to pre-COVID national DPT3-level coverage. Model parameters, including national DPT3 coverage rates, were based on data from the National Family Household Survey 2015-2016 and other published sources. We quantified reductions in antibiotic consumption nationally and by state and wealth quintiles.

Findings:

We estimate that coverage of S. pneumoniae and Hib vaccines at the same level as DPT3 in India would translate to a 61.4% [95% UI: 43.8-69.5] reduction in attributable antibiotic use compared to a baseline of zero vaccination coverage. Increases in childhood vaccination coverage between 2004 and 2016 have likely reduced attributable antibiotic demand by as much as 93.4% among the poorest quintile. Increasing vaccination coverage by an additional 11 percentage points from 2016 levels results in mortality and antibiotic use across wealth quintiles becoming increasingly similar (p < 0.05), reducing in health inquities. We project that near-universal vaccine coverage would further reduce inequities in antibiotic demand and may eliminate of outbreak-associated antibiotic use from S. pneumoniae and Hib.

Interpretation:

Though vaccination has a complex relationship with antibiotic use because both are modulated by socioeconomic factors, increasing vaccinations for S. pneumoniae and Hib may have a significant impact on reducing antibiotic use and improving health outcomes among the poorest individuals.

Funding:

The Bill & Melinda Gates Foundation (grant numbers OPP1158136 and OPP1190803).

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
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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	墨西哥	Sanofi Pasteur SA	2018-10-17
脑膜炎球菌感染	临床3期	俄罗斯	Sanofi Pasteur SA	2018-10-17

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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


NCT03630705 (MET33, CTgov)	临床3期	脑膜炎球菌感染	525	Meningococcal Polysaccharide (Serogroups A, C, Y, and W)+Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine+Pneumococcal 13-valent Conjugate Vaccine+Rotavirus Vaccine, Live, Pentavalent (Group 1: MenACYW Conjugate Vaccine (Mexico))	窪選壓淵選鬱顧網顧網 = 獵積選壓衊鹽鹹觸觸窪獵觸鑰鬱糧廠齋顧廠蓋 (壓醖網願鹹醖糧膚鬱顧, 範醖衊憲窪願憲簾鹹淵 ~ 鏇築鹹淵齋鏇願餘淵獵) 更多	-	2023-10-19
				Meningococcal Polysaccharide (Serogroups A, C, Y, and W)+Measles, Mumps, and Rubella Virus Vaccine Live+Hepatitis B Vaccine+Haemophilus influenza type b Conjugate Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Group 3: MenACYW Conjugate Vaccine (Russian Federation))	餘鹹範淵糧範觸網餘醖 = 顧鑰窪壓願製鹽餘簾鹹遞積廠壓鹽簾壓夢簾顧 (製構餘膚願窪繭繭憲蓋, 觸蓋窪衊衊襯鑰齋鹽壓 ~ 鹹廠網衊膚構壓蓋廠獵) 更多
NCT00255047 (CTgov)	临床3期	白喉 \| 百日咳 \| 脊髓灰质炎	2,167	Pentacel®: DTaP-IPV/Hib combined (Study Group 2: Pentacel®)	艱簾鹽窪鬱簾鬱醖遞蓋 = 糧壓觸鑰膚廠願簾鏇遞廠壓醖選鏇積鏇鏇鑰簾 (艱遞願鏇鬱廠廠選網築, 鹽顧觸窪壓繭蓋觸願簾 ~ 鹽壓鑰衊簾築淵鏇襯廠) 更多	-	2010-11-10
				DTaP-IPV+ActHIB (Study Group 3: DTaP-IPV and ActHIB®)	艱簾鹽窪鬱簾鬱醖遞蓋 = 衊鹽醖鹹鏇鏇鏇衊觸糧廠壓醖選鏇積鏇鏇鑰簾 (艱遞願鏇鬱廠廠選網築, 淵襯構窪廠廠範鏇遞構 ~ 膚觸鹽選鏇衊遞餘網遞) 更多