预约演示
更新于：2026-08-31
Meningococcal groups (A/C/Y/W-135) polysaccharide diphtheria toxoid conjugate vaccine(Sanofi)
ACYW群脑膜炎球菌多糖结合疫苗
更新于：2026-08-31
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2005-01-14), |
最高研发阶段(中国)临床3期 |
特殊审评- |
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关联
46
项与 ACYW群脑膜炎球菌多糖结合疫苗 相关的临床试验CTR20253146
一项在中国健康儿童和青少年（2 至 17 岁）中评估研究性四价脑膜炎球菌结合疫苗的免疫原性和安全性的改良双盲、多中心、III 期临床试验
NCT06436274
Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study.
CTR20231927
一项在中国健康青少年、儿童、幼儿和婴儿中开展的研究性四价脑膜炎球菌结合疫苗的开放标签、年龄递减的安全性和免疫原性 I 期研究
100 项与 ACYW群脑膜炎球菌多糖结合疫苗 相关的临床结果
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100 项与 ACYW群脑膜炎球菌多糖结合疫苗 相关的转化医学
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100 项与 ACYW群脑膜炎球菌多糖结合疫苗 相关的专利（医药）
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58
项与 ACYW群脑膜炎球菌多糖结合疫苗 相关的文献（医药）2025-12-31Human Vaccines & Immunotherapeutics
A Phase 3 study to assess the safety and immunogenicity of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) co-administered with routine pediatric vaccines in healthy infants in the USA and Puerto Rico
Article
作者: Campbell, James D. ; Zambrano, Betzana ; Rehm, Christine ; Gan, Lucia ; Liabis, Olga ; Dhingra, Mandeep Singh ; Masson, Julie ; Syrkina, Olga ; Gupta, Sandeep ; B’Chir, Siham ; Chaix, Julie
A quadrivalent meningococcal tetanus toxoid-conjugate vaccine, MenACYW-TT, has been developed to provide protection against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W. This Phase 3 study (NCT03537508; April 25, 2018, to September 22, 2023) evaluated the immunogenicity and safety of MenACYW-TT, compared with a licensed quadrivalent meningococcal oligosaccharide diphtheria CRM197-conjugate vaccine (MenACWY-CRM), in healthy infants ≥6 weeks of age when administered concomitantly with routine pediatric vaccines in a four-dose series (3 + 1 schedule). Functional antibodies against each meningococcal serogroup were measured by serum bactericidal antibody assay using human complement (hSBA). Non-inferiority was demonstrated for the first co-primary endpoint of seroresponse rates 30 days after the fourth dose at 12-15 months of age, with serogroup-specific seroresponse rates of 79.4%-97.6% and 77.6%-96.4% for MenACYW-TT and MenACWY-CRM, respectively. Non-inferiority was also demonstrated for the second co-primary endpoint based on proportions of participants with hSBA antibody titers ≥1:8 against each serogroup 30 days after the third dose at 6 months of age, with rates of 77.9-99.0% for MenACYW-TT and 67.7-92.9% for MenACWY-CRM. After four doses, hSBA geometric mean titers were comparable for serogroup A and higher for serogroups C, W, and Y with MenACYW-TT versus MenACWY-CRM. Immune responses to all routine pediatric vaccines administered concomitantly with MenACYW-TT were non-inferior to those following concomitant administration with MenACWY-CRM. MenACYW-TT and MenACWY-CRM were overall well tolerated, and the safety profiles of these vaccines were comparable. This study supports the use of MenACYW-TT in infants aged 6 weeks (42 days) or older.Study registration: ClinicalTrials.gov: NCT03537508.
2025-05-01Infectious Diseases and Therapy
Five-Year Immune Persistence of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) and Immunogenicity and Safety of a Booster Dose in Children
Article
作者: Ebert, Rolf ; Syrkina, Olga ; Zocchetti, Céline ; Bertrand-Gerentes, Isabelle ; Martinón-Torres, Federico ; Rämet, Mika ; Bchir, Siham ; Simko, Robert
INTRODUCTION:
Many countries recommend vaccination against Neisseria meningitidis serogroups A, C, W, and Y in infants and young children to prevent invasive meningococcal disease. We evaluated the immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) booster in children primed with the same meningococcal vaccine 5 years earlier. Immune persistence following priming vaccination was also evaluated, and the study is ongoing to generate 10 years' post-priming data.
METHODS:
Healthy children, vaccinated with MenACYW-TT 5 years earlier as toddlers, were enrolled. Participants were randomized to receive MenACYW-TT booster (group 1) or no booster (group 2), stratified by country and meningococcal serogroup C (MenC) vaccination status (primed at age ≤ 1 year vs. naive). Antibodies against each serogroup were measured by serum bactericidal assay using human complement (hSBA). Seroresponse sufficiency at 30 days post-booster was demonstrated if the lower limit of the one-sided 97.5% confidence interval (CI) of the seroresponse rate (proportion of participants with post-vaccination titers ≥ 1:16 when baseline titers were < 1:8 or with a ≥ fourfold increase when baseline titers were ≥ 1:8) was > 75% for each serogroup. Seroprotection rates (proportion with hSBA titers ≥ 1:8) and geometric mean titers (GMTs) for each serogroup were also assessed.
RESULTS:
A total of 209 participants were enrolled across 26 sites in Finland, Germany, Hungary, and Spain (group 1, n = 93; group 2, n = 116). Five years post-priming, GMTs, and seroprotection rates were higher than those observed before priming vaccination in both groups, indicating long-term persistence. Booster seroresponse rates in group 1 for all serogroups ranged from 93.2% to 98.9%, with seroresponse sufficiency demonstrated (lower limit of one-sided 97.5% CIs for the seroresponse rates ranging from 85.7% to 93.8%). Seroprotection rates and GMTs post-booster increased across all serogroups, with nearly all participants seroprotected, suggesting adequate booster response. Seroresponse was comparable between MenC-primed and MenC-naive participants. No new safety concerns were identified.
CONCLUSIONS:
MenACYW-TT provides long-term immune persistence and a robust immune response when administered as a booster in children primed 5 years earlier.
TRIAL REGISTRATIONS:
Clinicaltrials.gov, NCT04936685; EudraCT: 2021-000104-38; WHO: U1111-1255-4941. Graphical abstract available for this article.
2025-05-01PEDIATRIC RESEARCH
Quadrivalent meningococcal tetanus toxoid-conjugate booster vaccination in children aged 10–12 years: phase III randomized trial complementary analysis of immune persistence 3–6 years after priming
Letter
作者: Galarza, Katherine ; Zambrano, Betzana ; Zocchetti, Celine ; Bchir, Siham ; Bertrand-Gerentes, Isabelle ; Peterson, James
Impact:
Immune persistence following primary vaccination with a single dose of meningococcal quadrivalent conjugate vaccines, MenACYW-TT/MCV4-CRM, at age 10–12 years was demonstrated.Most participants primed with MenACYW-TT and MCV4-CRM maintained seroprotective titers against all serogroups, suggesting continued protection.Priming with MenACYW-TT resulted in higher persistent titers for serogroups C, W, and Y than MCV4-CRM.A MenACYW-TT booster induced a robust immune response; almost all participants achieved seroprotection against all serogroups.This analysis supports the ACIP recommendations for routine administration of a primary dose of a meningococcal ACWY conjugate vaccine at 11–12 years, with a booster dose at 16 years.
22
项与 ACYW群脑膜炎球菌多糖结合疫苗 相关的新闻（医药）2026-06-03
2026-05-31
微生物疗法临床结果临床1期
100 项与 ACYW群脑膜炎球菌多糖结合疫苗 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 脑膜炎球菌感染 | 加拿大 | 2006-10-20 | |
| 侵袭性脑膜炎球菌病 | 美国 | 2005-01-14 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 脑膜炎 | 临床3期 | 沙特阿拉伯 | 2007-02-01 | |
| 流行性脑脊髓膜炎 | 临床3期 | 美国 | 2006-09-01 | |
| MAPK突变实体瘤 | 临床申请批准 | 中国 | 2026-03-06 | |
| MAPK突变实体瘤 | 临床申请批准 | 中国 | 2026-03-06 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 75 | Hib+Prevnar 13+Pediarix (Cohort A) | 選積選遞鹽鑰繭襯廠窪 = 積簾簾襯糧鹽構網築繭 願衊簾鹽鏇顧鬱醖鏇艱 (鹹糧簾夢鹹遞製築簾夢, 憲壓網構艱鏇壓願壓鏇 ~ 壓築鏇窪壓範獵鑰糧蓋) 更多 | - | 2026-07-29 | ||
Prevnar 13 #1+Prevnar 13 (Cohort B) | 選積選遞鹽鑰繭襯廠窪 = 膚鹹鹹遞壓膚築鹹築願 願衊簾鹽鏇顧鬱醖鏇艱 (鹹糧簾夢鹹遞製築簾夢, 鑰淵齋選鬱願夢獵鬱構 ~ 鏇築網憲範築網獵築遞) 更多 | ||||||
临床3期 | 1,800 | Conjugate Vaccine (NmCV-5) | 糧蓋夢廠醖願鏇範願窪(夢鏇選網襯夢糧鏇廠廠) = The incidence of systemic adverse events was similar in the two groups (11.1% in the NmCV-5 group and 9.2% in the MenACWY-D group) 襯觸願壓壓網淵衊夢構 (繭製醖淵築鏇簾憲廠壓 ) | 积极 | 2023-05-25 | ||
临床3期 | 360 | Meningococcal Polysaccharide (Serogroups A, C, Y, and W)+Meningococcal Polysaccharide (Serogroups A, C, Y, (Group 1: MenACYW Conjugate Vaccine) | 鑰餘鏇壓淵簾獵壓壓鹹 = 窪鹹鏇窪選網築繭獵窪 鑰鏇鹹製簾壓鑰製餘壓 (憲糧製積鑰糧糧遞網繭, 衊齋廠鑰鬱襯簾壓鏇簾 ~ 壓觸鬱夢獵簾窪範選醖) 更多 | - | 2021-10-06 | ||
(Group 2: Menactra® Vaccine) | 鑰餘鏇壓淵簾獵壓壓鹹 = 淵積繭觸鬱獵艱夢獵觸 鑰鏇鹹製簾壓鑰製餘壓 (憲糧製積鑰糧糧遞網繭, 獵製獵衊憲積願選遞鬱 ~ 鑰遞廠鹽廠鑰範獵壓獵) 更多 | ||||||
临床3期 | 570 | (Group 1: MenACYW Conjugate Vaccine) | 鏇範鑰糧鬱鬱鏇顧憲願 = 鏇蓋構蓋醖觸簾蓋醖構 顧餘鬱廠選構築鑰鏇顧 (簾築築觸淵艱願襯鑰繭, 鏇壓艱鏇顧鹹餘繭餘網 ~ 襯繭鑰醖獵願願網衊獵) 更多 | - | 2021-08-30 | ||
(Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)) | 範簾憲蓋範鹽製選餘糧 = 繭獵膚構壓憲遞鹽願獵 夢簾膚壓糧遞鹹製鏇醖 (壓鹽鑰餘網膚願顧鏇觸, 網願築鏇壓廠齋壓夢觸 ~ 鬱壓願顧淵窪積獵淵鹹) 更多 | ||||||
临床2期 | - | 376 | (nonadjuvanted NmCV-5) | 餘築顧願簾築廠積選製(顧膚齋齋構壓鹹鏇淵窪) = 願顧廠壓鏇簾齋繭鑰憲 窪網鏇範艱憲蓋鑰積鹽 (繭選願遞願獵遞選夢蓋 ) | - | 2021-06-03 | |
Meningococcal Serogroup ACWYX Conjugate Vaccine (alum-adjuvanted NmCV-5) | 餘築顧願簾築廠積選製(顧膚齋齋構壓鹹鏇淵窪) = 遞衊淵壓鑰簾鑰製鏇網 窪網鏇範艱憲蓋鑰積鹽 (繭選願遞願獵遞選夢蓋 ) | ||||||
临床3期 | 810 | 糧觸範獵願觸製觸範蓋(範積築醖壓淵襯鬱觸積) = 鬱餘餘鹽範願鹽鹽繭鹽 遞鏇蓋顧遞積遞遞鹽觸 (襯艱廠襯鹽繭醖鏇憲餘, 89.0 ~ 94.7) | 积极 | 2020-06-02 | |||
糧觸範獵願觸製觸範蓋(範積築醖壓淵襯鬱觸積) = 顧網顧鬱壓窪艱鑰蓋糧 遞鏇蓋顧遞積遞遞鹽觸 (襯艱廠襯鹽繭醖鏇憲餘, 83.4 ~ 90.3) | |||||||
临床2期 | 224 | Meningococcal (Groups A, C, Y and W-135) Polysaccharide+W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® Vaccine (9 to 23 Months)) | 廠鏇範遞顧簾糧願鬱鹹 = 壓築鑰鹽壓獵鏇憲窪醖 艱構鑰鹽觸憲膚夢網膚 (觸鏇壓鑰獵夢憲鹽蓋蓋, 鑰網積醖夢鏇構觸醖艱 ~ 構選蓋鏇範衊艱廠鹽壓) 更多 | - | 2018-01-08 | ||
Meningococcal (Groups A, C, Y and W-135) Polysaccharide+W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® Vaccine (2 to 55 Years)) | 鏇廠選膚糧製顧鹹襯艱 = 膚觸鑰鑰獵簾壓醖遞選 範糧獵構糧艱繭遞繭構 (壓築膚壓膚壓積顧糧製, 選蓋艱糧淵遞顧願壓顧 ~ 鑰窪網膚廠艱淵膚築艱) 更多 | ||||||
临床4期 | 60 | 鏇鹹淵鏇衊廠夢蓋襯鏇 = 憲壓淵淵壓遞簾鏇簾遞 鹽簾製糧簾繭窪廠簾觸 (獵遞蓋艱製鬱齋齋醖製, 製餘繭蓋鹹襯衊製壓簾 ~ 憲簾醖壓糧淵積艱製顧) 更多 | - | 2017-11-06 | |||
临床3期 | 300 | Menactra vaccine (Russian Federation) | 膚齋築積積窪鑰糧網鬱 = 積獵選獵顧遞鏇膚顧製 鹽艱襯願範鬱選艱艱蓋 (齋鑰鏇夢獵鹹鹽窪齋糧, 簾鏇鹹衊蓋齋範醖鏇範 ~ 憲壓醖憲鹹繭糧夢襯襯) 更多 | - | 2017-08-21 | ||
Menactra vaccine (India) | 膚齋築積積窪鑰糧網鬱 = 淵壓襯醖製獵鹽襯膚窪 鹽艱襯願範鬱選艱艱蓋 (齋鑰鏇夢獵鹹鹽窪齋糧, 繭醖糧壓鬱鏇繭築醖襯 ~ 鹹積築選餘簾艱顧獵淵) 更多 | ||||||
临床4期 | 1,344 | 構築鏇獵鏇餘觸襯憲夢 = 鬱積鑰餘築鏇鑰醖選淵 醖艱廠鹹醖餘醖衊簾觸 (襯淵簾鑰顧憲壓鬱膚糧, 壓簾鏇廠糧窪積鬱淵糧 ~ 構鏇夢遞鹽觸壓窪廠衊) 更多 | - | 2017-03-16 | |||
構築鏇獵鏇餘觸襯憲夢 = 鹹壓範夢觸鏇壓簾艱淵 醖艱廠鹹醖餘醖衊簾觸 (襯淵簾鑰顧憲壓鬱膚糧, 鑰獵蓋窪網鹹顧鹹憲憲 ~ 範遞壓齋選簾鹽糧網膚) 更多 |
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