The purpose of the study was to evaluate the immunogenicity and describe the safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed Meningococcal polysaccharide groups A, C, W-135 and Y (Nimenrix®) Conjugate vaccine in toddlers 12 to 23 months of age in the European Union (EU). The toddlers were either meningococcal vaccine naïve or had received monovalent meningococcal C (MenC) vaccination during infancy to evaluate any potential impact of the meningococcal vaccine background on the immunogenicity and safety profile of the investigational product.
Primary Objectives:
* To demonstrate the non-inferiority of the antibody response to meningococcal serogroups A, C, Y, and W after a single dose of MenACYW Conjugate vaccine or Nimenrix® in toddlers who either were meningococcal vaccine naïve or had received monovalent MenC vaccination during infancy.
* To demonstrate the non-inferiority of the antibody response to meningococcal serogroups A, C, Y, and W after a single dose of MenACYW Conjugate vaccine or Nimenrix® in meningococcal vaccine naïve toddlers.
Secondary Objectives:
* To compare the antibody responses (geometric mean titers [GMTs]) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW Conjugate vaccine or Nimenrix® as measured by serum bactericidal assay using human complement (hSBA) in toddlers who either were meningococcal vaccine naïve or had received monovalent MenC vaccination during infancy.
* To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW Conjugate vaccine or Nimenrix® as measured by hSBA in meningococcal vaccine naïve toddlers.
* To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW Conjugate vaccine or Nimenrix® as measured by hSBA in toddlers who received monovalent MenC vaccination during infancy.

开始日期2017-02-24

申办/合作机构

Sanofi Pasteur SA

NCT00862277

/ CompletedN/A

Evaluation of the Persistence of Bactericidal Antibodies in Adolescents and Adults Who Received a Single Dose of Menactra® Four to Eight Years Earlier

To evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of Menactra® vaccine approximately four to eight years earlier

开始日期2008-12-01

申办/合作机构

Sanofi Pasteur SA

NCT00422292

/ Completed临床3期

An Immunogenicity, Safety, and Non-Interference Evaluation of Pediatric Vaccines Administered Concomitantly With Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) to Healthy Toddlers

This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers.
Primary Objectives:
* To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine.
* To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when administered alone or concomitantly with Menactra vaccine.
Observational Objectives:
Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6 months after the last study vaccination[s]) in subjects in the study groups.
Immunogenicity:
- To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days after the first and second Menactra vaccine administration in a subset of subjects in the first study group.

开始日期2006-12-01

申办/合作机构

Sanofi Pasteur SA

100 项与 A/ C/ Y/ W-135群脑膜炎球菌多糖联合疫苗(Sanofi) 相关的临床结果

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100 项与 A/ C/ Y/ W-135群脑膜炎球菌多糖联合疫苗(Sanofi) 相关的转化医学

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100 项与 A/ C/ Y/ W-135群脑膜炎球菌多糖联合疫苗(Sanofi) 相关的专利（医药）

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项与 A/ C/ Y/ W-135群脑膜炎球菌多糖联合疫苗(Sanofi) 相关的文献（医药）

2021-08-01·Journal of clinical pharmacy and therapeutics4区 · 医学

Improving meningococcal MenACWY and 4CMenB/meningococcal group B vaccine‐related health literacy in patients: Importance of readability of pharmaceutical Patient Leaflets

4区 · 医学

Article

作者: Moore, Peter JA ; Millar, Beverley C. ; Moore, John E. ; Brennan, Orlaith C. ; Nutt, Thomas W.

WHAT IS KNOWN AND OBJECTIVE:

Patient information leaflets (PILs) or Patient Leaflets (PLs) formally accompany dispensed medicines and are intended to provide the patient with information on how to use the medicine safely. To date, there have been no studies that have examined the readability of meningococcal vaccine patient-facing information, including information contained within the vaccine PIL. Given the role of pharmacists in presenting PILs to patients, it was, therefore, the aim of this study to quantitatively analyse the readability of Patient Leaflets, which accompany licensed meningococcal vaccines in the UK and US and to compare PILs to vaccine pharmaceutical manufacturers' summary of product characteristics (SPC), as well as other patient-facing vaccine-related information.

METHODS:

Five sources of meningococcal vaccine information were examined for the licensed meningococcal vaccines in the UK (Bexsero, Menveo, Menitorix, Trumenba, Nimenrix & NeisVac-C) and in the United States (Bexsero, Menveo, Trumenba, Menactra, Menomune-A/C/Y/W-135, Menquadfi), including as follows: (i) SPC (Electronic Medicines Compendium, UK), (ii) Package Insert (FDA; USA), (iii) Patient Leaflet (Electronic Medicines Compendium, UK), (iv) Vaccine pharmaceutical websites and (v) government web resources. Readability was examined employing 10 readability metrics, including the Flesch Reading Ease and the Flesch-Kincaid Grade level.

RESULTS AND DISCUSSION:

The information source with the greatest readability scores was the UK Patient Leaflet, which had a mean Flesch Reading Ease score of 58.1 and a mean Flesch-Kincaid Grade score of 7.3, followed by the US Department of Health & Human Services patient-facing website for vaccines (55.9 & 8, respectively), followed by the US Centers for Disease Control and Prevention Vaccine Information Statement (47.3 & 9.4, respectively). Pharmaceutical patient-facing websites for meningococcal vaccines had mean scores of 44.6 and 9.9, respectively. When compared with UK Patient Leaflets, pharmaceutical websites were statistically different with poorer readability with both Flesch Reading Ease and Flesch-Kincaid Grade Level indices (p = 0.02 & p = 0.04, respectively).

WHAT IS NEW AND CONCLUSION:

Pharmaceutical meningococcal vaccine PILs were easily read and had statistically significant good readability scores in comparison with vaccine SPCs and US Package Inserts, pharmaceutical product websites and other government patient-facing meningococcal vaccine information. Preparation of patient-facing materials of a complex topic, such as describing meningococcal vaccines, is difficult to accomplish. Although there is a plurality of sources of information through websites and social media, PILs are one of the few sources that are provided directly to patients. This underpins the potential importance of PILs and the importance of their readability. Adoption of readability calculators and scrutiny of materials for their readability will help authors develop materials with improved understanding for vaccine recipients, potentially leading to improved health literacy and vaccine uptake. Renewed efforts should be sought to promote the information within the PIL, thereby maximizing the value of this resource with vaccine recipients, their carers and family.

2005-11-04·Human vaccines

Safety and Immunogenicity of a Meningococcal (Groups A, C, Y, W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Children Aged 2 to 10 Years in Chile

Article

作者: Ryall, Robert ; Pina, Miriam ; Bassily, Ehab ; Lagos, Rosanna ; Papa, Thomas ; Munoz, Alma

Immune responses to meningococcal conjugate (Menactra; MCV-4) and plain polysaccharide (Menomune-A/C/Y/W-135; PSV-4) vaccines against serogroups A, C, Y, and W-135 were assessed in 220 of 1037 Chilean children aged 2 to 10 years participating in a comparative safety trial. Both vaccines were generally well tolerated. Geometric mean serum bactericidal antibody (SBA) titers 28 days postvaccination were comparable in both groups for all four serogroups. Seroconversion was evident in > 97% of MCV-4 and > 90% of PSV-4 vaccinees who tested seronegative at baseline. Menactra safely induced broad and robust immune responses against serogroups A, C, Y and W-135 in this population.

2005-10-01·Archives of pediatrics & adolescent medicine

Safety, Immunogenicity, and Immune Memory of a Novel Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MCV-4) in Healthy Adolescents

Article

作者: Al Reinhardt ; Katalin Koranyi ; Michael J. Bybel ; Ehab Bassily ; Harry Keyserling ; Thomas Papa ; Robert Ryall ; Gregory Gilmet ; Kevin Sullivan

OBJECTIVE:

A meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV-4; Menactra; Sanofi Pasteur Inc, Swiftwater, Pa) was developed to improve the profile of currently licensed products. The objective of this study was to compare the tolerability, immunogenicity, and immune memory of MCV-4 with those of a quadrivalent polysaccharide vaccine (PSV-4; Menomune A/C/Y/W-135; Sanofi Pasteur Inc).

DESIGN, SETTING, PARTICIPANTS:

A randomized, double-blind trial was performed at 11 clinical centers in the United States. The vaccine MCV-4 or PSV-4 was administered to 881 healthy 11- to 18-year-olds. Sera were collected prevaccination and 28 days postvaccination. Three-year follow-up and booster vaccination with MCV-4 were performed in a participant subset from each group and a control group.

MAIN OUTCOME MEASURES:

Proportion of participants with a 4-fold or greater increase in serum bactericidal antibody against each serogroup 28 days after initial vaccination, geometric mean serum bactericidal antibody titers, and safety assessments.

RESULTS:

Both vaccines were well tolerated; most reactions were mild. More MCV-4 recipients reported solicited local reactions (68.9%) than PSV-4 recipients (30.2%). Both MCV-4 and PSV-4 were highly immunogenic; similar proportions of participants had 4-fold or greater increases in serum bactericidal antibody (range, 80.1%-96.7%) to the 4 serogroups. Three-year follow-up showed persistence of serum bactericidal antibody and booster responses to MCV-4 consistent with immune memory in participants previously vaccinated with MCV-4, but not in those who had previously received PSV-4.

CONCLUSIONS:

The vaccine MCV-4 was well tolerated and highly immunogenic. Persistence of bactericidal activity with MCV-4, but not PSV-4, was evident 3 years after the initial immunization. Booster response was demonstrated after a second vaccination with MCV-4.

项与 A/ C/ Y/ W-135群脑膜炎球菌多糖联合疫苗(Sanofi) 相关的新闻（医药）

2024-04-26

·药智网

流脑疫苗市场的新突破

在出生人口继续减少，流脑疫苗被纳入免疫规划免费产品的情况下，康希诺用于儿童流脑结合疫苗销售收入却较去年同期增长266%。流脑疫苗市场为何颠覆市场预期？01 接种率持续提升脑膜炎可由细菌、真菌、病毒等因素引起，其中细菌性脑膜炎（bacterial meningitis，BM）是最常见、危险及疾病负担最高的脑膜炎类型。肺炎链球菌（Streptococcus pneumoniae，SP）、脑膜炎奈瑟菌或称脑膜炎球菌（Neisseria meningitidis，NM））及B型流感嗜血杆菌（Hib）是世界范围内引起BM的三大致病菌。其中由NM引起的流脑具有发病急、进展快、传染性强、隐性感染率高、病死率高等特点。全球范围内流脑病死率超过10%，致残率高，疾病负担严重。引起流脑病例的NM血清群主要为A、B、C、W、Y和X血清群，合计占比达95%。目前A群流脑病例构成总体呈减少趋势，C群流脑病例构成呈先增加后减少趋势，B、W和其他血清群（包括未分群）流脑病例的构成则呈上升趋势。全球及中国脑膜炎发病率呈逐年下降的趋势。从地区分布来看，脑膜炎发病率最高的国家是印度，其次为巴西。脑膜炎疾病负担最重的是撒哈拉以南非洲地区，即非洲脑膜炎带。从患病人数上看，2019年全球脑膜炎患者约768万，其中印度脑膜炎患者人数最多为210万，中国脑膜炎患者约有21万。世卫组织制定了“到2030年战胜脑膜炎”全球路线图，在此目标下，预计未来预防细菌性脑膜炎疫苗的接种率将持续提升，全球脑膜炎患者人数将呈下降趋势。图1全球及主要国家脑膜炎患病人数（单位：万）数据来源：药智数据，药智咨询整理02 多价流脑结合疫苗为主流产品经调研，截至2024年1月，按品牌（活性成分+企业）计，全球已上市流脑疫苗共有37个（见图2）。由辉瑞研发的Penbraya是全球首款、也是唯一一款五价疫苗（ABCWY），该疫苗于2023年10月获FDA批准上市，用于在10至25岁人群中预防由A、B、C、W和Y血清型脑膜炎双球菌引起的侵袭性疾病。由印度血清研究所研发的MenFive是第一款适合非洲使用的五价脑膜炎球菌结合疫苗（ACYWX），已获得世界卫生组织（WHO）的资格预审。由赛诺菲巴斯德研发的Menomune为全球首款ACYW群脑膜炎球菌多糖疫苗，不过赛诺菲巴斯德已于2017年发布Menomune的停产声明。全球已上市2款B群脑膜炎球菌疫苗，分别为辉瑞的Trumenba和葛兰素史克的Bexsero，中国尚无B群脑膜炎球菌疫苗上市。中国已上市流脑疫苗按品牌（活性成分+企业）计共有23个，包括ACYW群脑膜炎球菌结合疫苗1个、ACYW群脑膜炎球菌多糖疫苗7个、A群C群脑膜炎球菌结合疫苗6个、A群C群脑膜炎球菌多糖疫苗5个、A群脑膜炎球菌多糖疫苗4个。2021年12月，康希诺自主创新研发的四价流脑结合疫苗曼海欣（ACYW135结合疫苗）正式获国家药监局批准上市，成为我国首款获批上市的4价流脑结合疫苗。图2 全球及中国批准上市的流脑疫苗-按品牌计数据来源：药智数据，药智咨询整理全球在研流脑疫苗共有22个。其中ABCWY群脑膜炎疫苗3个、AC-Hib联合疫苗1个、ACYW结合疫苗10个、ACYW多糖疫苗1个、Hib疫苗2个、AC结合疫苗2个、AC多糖疫苗1个、A群多糖疫苗1个。整体来看，四价流脑结合疫苗、B群疫苗和ABCWY群脑膜炎疫苗在研产品较多。国内在研管线方面，已有4家企业的ACYW群结合疫苗处于临床Ⅲ期阶段；而B群疫苗仅有北京智飞绿竹的重组B群脑膜炎球菌疫苗（大肠杆菌）处于临床阶段；另外国内暂无五价流脑疫苗处于临床阶段。预计未来国内ACYW结合疫苗竞争较激烈，B群脑膜炎球菌疫苗竞争较小。03 市场规模有所下降，但目标人群支付能力提高2022年流脑疫苗市场规模同比2021年下降幅度较大，销售额同比下降35.38%，批签发量同比下降36.05%。在供应端，规模较大的沃森生物在2022年，供应大幅减少，AC结合疫苗和ACYW135多糖疫苗无批签发，AC多糖疫苗批签发量下降66%，年报显示是因为公司推动双价HPV疫苗和ACYW135多糖疫苗的世界卫生组织预认证（WHO-PQ）工作，项目整改等原因进行了设备改造，加之相关产品生产计划的调整，导致部分疫苗产品批签发数量下降较大。在需求端，近几年出生人口下降幅度较大，2022年中国出生人口首次跌破1000万，带来流脑疫苗需求的下降。图3 中国流脑疫苗总体市场规模及发展趋势--按销售额计图4 中国流脑疫苗总体市场规模及发展趋势--按批签发量计数据来源：药智数据，药智咨询整理注：销售额：药智数据库收录的各产品中标价中位数*批签发量；批签发量：2018年-2020年的数据来源中检院批签发公布信息，2021年和2022年的数据来源于企业年报，无年报披露的数据根据批签发次数和过往批签发量测算。国内曾上市AC-Hib联合疫苗，适用对象为2月龄至5周岁儿童，主要用于同时预防A群、C群脑膜炎球菌以及b型流感嗜血杆菌引起的脑膜炎、肺炎、败血症、蜂窝组织炎、关节炎、会厌炎等感染性疾病。该疫苗是智飞绿竹的独家产品，2018年销售额达17.57亿元，为该领域中销售额最高的产品。但是2020年注册批件到期后药监局给出了不予再注册审批意见。目前国内尚无AC-Hib联合疫苗在售，智飞生物、欧林生物AC-Hib冻干疫苗在研，该品种再次上市后市场规模可能会快速增长。AC多糖疫苗、A群多糖疫苗为免疫规划疫苗，批签发量较高，但是近5年这两类疫苗的批签发量和销售额都处于下降趋势。而AC结合疫苗、ACYW135多糖疫苗、ACYW135结合疫苗这三类自费疫苗，在整体出生人口下降的背景下，销售额和批签发量都处于增长趋势，说明家长对儿童的健康重视程度高，对效果好的产品需求大，支付能力也在提高。图5 流脑疫苗品种市场分布数据来源：药智数据，药智咨询整理04 结语脑膜炎疫苗在国内还存在较大未满足需求。（1）目前免疫规划内的脑膜炎疫苗品种较少且存在有效性不足的情况，而非免疫规划疫苗由于价格较贵、接种意识等原因，其接种率偏低，还存在较大发展潜力；（2）中国目前尚无B群脑膜炎球菌疫苗获批上市，但B群菌株已成为最主要的流行血清群，因此亟需开发B群脑膜炎球菌疫苗产品。声明：本内容为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 八角转载开白 | 马老师 18996384680（同微信）如需定制医药咨询服务，请扫描下方二维码咨询！阅读原文，是受欢迎的文章哦

上市批准疫苗临床研究

100 项与 A/ C/ Y/ W-135群脑膜炎球菌多糖联合疫苗(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
脑膜炎球菌感染	法国	Aventis Pasteur MSD SNC	2002-03-17
脑膜炎球菌感染	意大利	Aventis Pasteur MSD SNC	2002-03-17
侵袭性脑膜炎球菌病	美国	Sanofi Pasteur, Inc.	1999-12-09

未上市

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适应症	最高研发状态	国家/地区	公司	日期
流行性脑脊髓膜炎	临床3期	美国	Sanofi Pasteur SA	2006-12-01
脑膜炎	临床2期	英国	Sanofi Pasteur SA	2003-08-01

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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


NCT02955797 (CTgov)	临床3期	流行性脑脊髓膜炎	918	Meningococcal Polysaccharide (Serogroups A, C, Y, and W) (Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine)	遞願衊獵齋鹹鹽鹽憲襯 = 積鹽願鬱鏇鑰鬱獵憲製齋顧築蓋觸顧鑰淵襯觸 (衊鬱齋壓蓋襯廠壓築壓, 鑰醖鏇衊憲齋構醖遞壓 ~ 糧範觸窪餘衊夢餘積積) 更多	-	2020-06-09
				Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine (Group 2 (Meningococcal Vaccine-Naive): Nimenrix®)	遞願衊獵齋鹹鹽鹽憲襯 = 糧鑰壓醖憲廠廠憲廠築齋顧築蓋觸顧鑰淵襯觸 (衊鬱齋壓蓋襯廠壓築壓, 鏇糧鬱鑰鹹範遞網觸窪 ~ 鬱壓顧選醖鏇窪鬱遞蓋) 更多
NCT00422292 (CTgov)	临床3期	流行性脑脊髓膜炎	1,664	Menactra (Group 1: Menactra® at 9 and 12 Months)	範積築艱衊廠衊簾範鹽(餘憲糧網餘遞醖襯醖餘) = 蓋顧齋築網顧廠製積蓋壓糧鏇鑰餘顧遞衊鏇齋 (餘顧糧壓蓋鑰壓壓製蓋, 窪築淵製鬱繭繭構鑰鑰 ~ 鑰糧簾鹹製襯築繭膚衊) 更多	-	2011-06-02
				MMRV+Menactra (Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months)	衊壓糧衊製膚範蓋遞鏇 = 憲願製窪蓋鏇遞壓淵鹽鹹觸憲獵範鏇構鑰衊鏇 (淵簾鏇範襯淵鑰遞憲選, 鏇醖窪積襯憲艱艱膚選 ~ 網簾願夢夢選網網窪鹹) 更多
NCT00771849 (CTgov)	临床2期	脑膜炎 \| 脑膜炎球菌感染	103	Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra® Vaccine Group)	願範壓積蓋鏇醖壓選積(顧鑰襯窪膚餘壓壓衊齋) = 齋廠廠鑰範鹹選壓夢夢鏇醖範構願築獵製網網 (遞鹹憲蓋糧獵鏇築憲鑰, 繭遞積鹹憲獵膚鏇夢積 ~ 積觸積網糧簾繭醖襯鑰) 更多	-	2009-04-24
				Haemophilus Influenzae Type b (Hib) vaccine (Hiberix® Vaccine Group)	願範壓積蓋鏇醖壓選積(顧鑰襯窪膚餘壓壓衊齋) = 構夢鬱築憲夢遞蓋網窪鏇醖範構願築獵製網網 (遞鹹憲蓋糧獵鏇築憲鑰, 選鑰餘願衊餘餘遞夢鏇 ~ 鬱壓構願憲顧鏇顧獵鏇) 更多