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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327

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 ; 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.

2024-11-01·INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE

Adverse outcome detection of childhood administered thimerosal-free HibTITER^®

Article

作者: Hooker, Brian ; Jablonowski, Karl

Background:

Haemophilus influenzae type b (HIB) is a gram-negative pathogenic bacterium that mostly impacts the pediatric and geriatric population, sometimes resulting in permanent sequelae or death.

Objective:

In this study we set out to discover adverse outcomes from the thimerosal-free HibTITER® vaccine derived from a Florida Medicaid dataset spanning from January 2003 to June 2007 ( n = 277,484).

Methods:

HIB vaccinated children were isolated from the Florida Medicaid dataset. Using other HIB vaccines as the control, we analyzed diagnoses for statistically significant adverse outcomes related to the HibTITER® vaccine (only the strictest p-value of <0.0001 was used in analyzing this dataset). We simultaneously and independently examined the statistical significance of symptoms reported to VAERS related to HIB vaccines to corroborate our findings ( p-value significance was reported at <0.05, <0.001, and <0.0001).

Results:

The study revealed 19 individual ICD-9 codes positively associated ( p-value<0.0001 post Bonferroni correction) with recipients of the HibTITER® vaccine within 30-days of vaccination. Of these conditions, 14 have VAERS corroborators. The diseases span severity from mild to life-threatening and areas of respiration (e.g., asthma), gastrointestinal, otolaryngologic (e.g., common cold), dermatologic, generalized infections (e.g., tuberculosis), and other conditions.

Conclusion:

Incidence of 19 different medical conditions was significantly higher compared to the control group who received other HIB vaccine formulations. These results were corroborated using the VAERS database, and have profound medical implications for the estimated 35 million Americans between the ages of 16 and 33 who received the vaccine.

2024-07-02·ACTA MICROBIOLOGICA ET IMMUNOLOGICA HUNGARICA

Epidemiological and bacterial profile of childhood meningitis in Tunisia

Article

作者: Bouafsoun, Aida ; Menif, Khaled ; Kechrid, Amel ; Khiari, Houyem ; Dhraief, Sarra ; Borgi, Aida ; Meftah, Khaoula ; Aloui, Firas ; Mhimdi, Samar ; Haddad-Boubaker, Sondes ; Smaoui, Hanen ; Brik, Amani

Abstract:

The worldwide burden of disease of bacterial meningitis remains high, despite the decreasing incidence following introduction of routine vaccination campaigns.The aim of our study was to evaluate the epidemiological and bacteriological profile of paediatric bacterial meningitis (BM) in Tunisian children, during the period 2003–2019, following the implementation of Haemophilus influenzae type b (Hib) vaccine (April 2011) and before 10-valent pneumoccocal conjugate vaccine (PCV10) introduction to the childhood immunization program.All bacteriologically confirmed cases of BM admitted to children's hospital of Tunis were recorded (January 2003 to April 2019). Serogroups of Neisseria meningitidis (Nm) and serotypes of Streptococcus pneumoniae (Sp) and H. influenzae (Hi) and antibiotic resistance were determined using conventional and molecular methods.Among 388 cases, the most frequent species were Sp (51.3%), followed by Nm (27.5%) and Hi (16.8%). We observed a significant decrease in Hi BM rate during the conjugated Hib vaccine use period (P < 0.0001). The main pneumococcal serotypes were 14, 19F, 6B, 23F and 19A and the serotype coverage of PCV10, PCV13, PCV15 and PCV20 was 71.3 and 78.8%, 79.4 and 81.9% respectively. The most frequent Nm serogroup was B (83.1%). Most Hi strains were of serotype b (86.9%). High levels of resistance were found: Sp and Nm to penicillin (respectively 60.1 and 80%) and Hi to ampicillin (42.6%). All meningococcal and Hi isolates were susceptible to third-generation cephalosporins and 7.2% of pneumococcal strains had decreased susceptibility to these antibiotics.The Hib conjugate vaccine decreased the rate of BM. Sp dominated the aetiology of BM in children in Tunisia. Conjugate vaccines introducing decreases not only BM cases but also antimicrobial resistance.

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
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研发状态

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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	2000-02-04

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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))	構願網選膚夢網餘襯顧 = 鏇膚願積艱餘憲鏇鑰醖觸製願獵膚衊選淵鑰網 (鑰鏇觸鬱鹹選遞壓齋壓, 獵艱鬱鹽鏇範鑰獵蓋網 ~ 願壓壓齋繭襯餘壓獵構) 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))	淵顧遞構醖窪製製範衊 = 襯顧鹹遞遞範範選蓋構觸遞範膚壓觸製鬱淵艱 (獵構襯壓鏇憲鹹顧獵鹽, 艱壓觸淵積繭糧構願鹽 ~ 鑰鏇憲顧繭繭積選選獵) 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®)	襯夢遞蓋襯鑰築廠糧鹹 = 醖廠膚願壓窪顧獵顧蓋遞簾願鑰鏇鹽鑰廠齋觸 (築鬱淵膚築構窪觸範遞, 膚憲築繭選鑰鬱膚憲糧 ~ 鏇積鏇餘艱襯觸窪願積) 更多	-	2010-11-10
				DTaP-IPV+ActHIB (Study Group 3: DTaP-IPV and ActHIB®)	襯夢遞蓋襯鑰築廠糧鹹 = 醖夢餘壓繭膚齋齋襯選遞簾願鑰鏇鹽鑰廠齋觸 (築鬱淵膚築構窪觸範遞, 廠鬱鬱遞淵鹹遞淵選範 ~ 網簾構網築衊蓋繭顧齋) 更多