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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519

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 ; O'Sullivan, Michael ; McAlister, Sonia ; McIntyre, Peter B ; Totterdell, James ; 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 ; Hu, Huili ; Wang, Yajuan ; Leng, Zhiqin ; Yin, Jun ; Shen, Xuzhuang

2025-01-01·Environmental Health and Preventive Medicine

Estimated coverage of vaccines for children in Japan between 2011 and 2022: a descriptive study utilizing nationwide monthly market data

Article

作者: Miyata, Jun ; Fukuma, Shingo

BACKGROUND:

Japan lacks comprehensive reports on the nationwide voluntary vaccine coverage. The effectiveness of public subsidies in promoting vaccination has not been fully investigated. Therefore, we aimed to estimate the nationwide coverage of voluntary vaccines, compare it with that of national immunization program (NIP)-included vaccines, and investigate the effectiveness of public subsidies.

METHODS:

We obtained nationwide monthly vaccine market data for rotavirus, Haemophilus influenzae type b (Hib), diphtheria, tetanus toxoid, acellular pertussis, inactivated poliovirus (DTaP-IPV), and mumps vaccines; estimated recipient numbers; and calculated coverage as the proportion of children from October 2011 to March 2022. Regarding the NIP-included vaccine, we compared vaccine coverage calculated from nationwide annual market data with that estimated by World Health Organization (WHO)/United Nations Children's Fund (UNICEF), using Bland-Altman analysis.

RESULTS:

The estimates of Hib and DTaP-IPV vaccine coverage derived from market data were slightly higher than the WHO/UNICEF estimates, with mean differences of 0.05 (95% CI: 0.02-0.07) for Hib and 0.03 (95% CI: 0.01-0.05) for DTaP-IPV. The coverage of the rotavirus vaccine gradually increased long before the implementation of national subsidies, reaching 0.9 in 2020. Hib vaccine coverage had already achieved 1.0 by January 2012. The coverage of the DTaP-IPV vaccine was approximately 0.6-0.8 in 2013, reaching 1.0 in 2014. The coverage of mumps vaccine increased gradually from 2011 to 2021.

CONCLUSIONS:

Despite the possibility of overestimation, our estimates may serve as a valuable surrogate for actual vaccine coverage in Japan. An increasing trend in rotavirus and mumps vaccine coverage was observed when these vaccines were categorized as voluntary. Although vaccination policies differ from country to country, it would be beneficial to share findings on the impact of subsidies in Japan with other countries.

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

2018-10-31

·daiichisankyo.com

Announcement for partnership termination of sales and information provision of lyophilized hemophilus influenza type b vaccine “ActHIB®” in Japan

PDF (106KB)PDF For Immediate Release Sanofi K.K. Daiichi Sankyo Company, Limited Sanofi K.K. (Head Office: Shinjuku-ku, Tokyo; President: Jacques Nathan; hereafter “Sanofi”) and Daiichi Sankyo Company, Limited (Head Office: Chuo-ku Tokyo; President: Sunao Manabe; hereafter, Daiichi Sankyo) announced today that the partnership agreement for sales and information provision activities for the lyophilized hemophilus influenza vaccine type b “ActHIB®” will be terminated by the end of December 2018. “ActHIB®” was developed and manufactured by Sanofi Pasteur in France, and Sanofi has had manufacturing and sales approval in Japan since January 2007. Under the partnership agreement between Sanofi and Daiichi Sankyo, Daiichi Sankyo has engaged in sales and information provision activities of “ActHIB®” since December 2008. Based on the agreement, both companies have contributed to improve public health in Japan; however, due to the expiration of the distribution and co-promotion agreement of “ActHIB®,” Sanofi and Daiichi Sankyo have agreed to terminate the partnership as of the end of December 2018. From January 1, 2019, Sanofi will solely engage in sales and information provision activities of “ActHIB®.” Daiichi Sankyo will continue the distribution of “ActHIB®” until the end of December, 2019, and Sanofi will take it over from January 1, 2020. Both companies will cooperate to smoothly complete the transition. In addition to improving public health in Japan through the supply of pharmaceuticals, including vaccines, both companies will continue to contribute to the prevention and treatment of diseases as well as to the improvement of public health. About Sanofi Sanofi is dedicated to supporting people through their health challenges. As a global biopharmaceutical company focused on human health, we protect people with our vaccines and ease their pain and suffering with our innovative treatments. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Please visit the company’s website http://www.sanofi.co.jpOpen new window. for details of Sanofi K.K. About Daiichi Sankyo Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.com/ Contact Sanofi K.K. Communications TEL: 03-6301-4148 DAIICHI SANKYO COMPANY, LIMITED Corporate Communications Department Phone：+81-3-6225-1126 https://www.daiichisankyo.com

疫苗上市批准引进/卖出

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
流感嗜血杆菌感染	美国	Sanofi Pasteur SA	2022-07-27
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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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	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))	簾鏇願夢醖憲蓋壓襯襯 = 鏇襯淵繭夢壓鏇糧窪鑰鏇範願窪鹹選繭簾襯鑰 (鑰獵鑰壓願網壓糧網蓋, 繭壓鏇餘廠簾憲衊簾蓋 ~ 築遞觸製廠繭觸齋構積) 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))	窪繭壓鹽簾憲製夢餘蓋 = 顧糧齋獵壓憲願繭鏇淵顧鏇簾糧簾壓艱廠廠鏇 (製鹽膚構網憲簾築鏇衊, 餘蓋選鬱構鑰餘選獵鏇 ~ 蓋簾淵繭齋網顧繭醖憲) 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®)	壓遞齋繭願鬱夢壓製艱 = 蓋膚簾選齋窪膚遞積衊獵積餘衊醖構襯積築壓 (膚鏇遞願鹽顧遞齋淵糧, 鏇鹹範衊遞壓廠艱襯壓 ~ 衊壓齋願醖襯顧齋衊廠) 更多	-	2010-11-10
				DTaP-IPV+ActHIB (Study Group 3: DTaP-IPV and ActHIB®)	壓遞齋繭願鬱夢壓製艱 = 鏇衊構範憲窪製醖憲願獵積餘衊醖構襯積築壓 (膚鏇遞願鹽顧遞齋淵糧, 壓築膚築窪膚膚鹹窪淵 ~ 膚膚窪觸繭齋積膚選網) 更多