预约演示
更新于：2026-09-07
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：2026-09-07
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- |
登录后查看时间轴
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
登录后查看更多信息
100 项与 ACYW群脑膜炎球菌多糖结合疫苗 相关的转化医学
登录后查看更多信息
100 项与 ACYW群脑膜炎球菌多糖结合疫苗 相关的专利（医药）
登录后查看更多信息
59
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
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 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
登录
| 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 |
登录后查看更多信息
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) | 構醖廠鹹獵鏇衊觸醖鏇 = 鹽醖鬱淵壓糧鏇製襯壓 積範齋網積積構築積積 (憲構壓繭觸製糧繭選壓, 構淵艱壓壓範選網鏇獵 ~ 壓壓憲獵鹽膚構餘壓鹹) 更多 | - | 2026-07-29 | ||
Prevnar 13 #1+Prevnar 13 (Cohort B) | 構醖廠鹹獵鏇衊觸醖鏇 = 願鹽膚觸獵餘襯憲糧積 積範齋網積積構築積積 (憲構壓繭觸製糧繭選壓, 憲鏇鏇觸網鏇廠觸醖構 ~ 獵製夢鑰觸憲築齋鏇淵) 更多 | ||||||
临床3期 | 1,800 | Conjugate Vaccine (NmCV-5) | 鏇夢壓觸廠選憲製範糧(壓範艱糧衊窪鹹鹽鹹夢) = 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) 簾廠鹹遞鹽鹹獵壓窪夢 (獵鹹糧觸構製壓壓選鏇 ) | 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) | 遞顧膚夢繭壓膚鹹獵鏇 = 願鑰淵窪憲醖窪鏇範糧 壓蓋鹽膚壓願鑰網製願 (積獵淵製鏇鑰簾選膚齋, 範獵夢願蓋簾鹹鏇窪襯 ~ 壓鬱膚顧廠簾餘簾窪鹽) 更多 | - | 2021-10-06 | ||
(Group 2: Menactra® Vaccine) | 遞顧膚夢繭壓膚鹹獵鏇 = 觸壓窪餘齋壓構憲顧淵 壓蓋鹽膚壓願鑰網製願 (積獵淵製鏇鑰簾選膚齋, 窪餘糧製鬱夢範夢壓糧 ~ 願製襯獵選觸淵壓蓋壓) 更多 | ||||||
临床3期 | 570 | (Group 1: MenACYW Conjugate Vaccine) | 鏇廠觸獵蓋鹹願觸繭簾 = 鑰築鑰壓觸製觸獵觸夢 鹽鹹製積遞選觸衊夢膚 (衊醖遞蓋願積鏇製艱顧, 獵築窪選憲壓壓積構製 ~ 鏇網選壓選顧顧選壓繭) 更多 | - | 2021-08-30 | ||
(Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)) | 鑰醖廠鏇獵顧選網蓋鹽 = 獵鑰積築憲襯膚膚顧製 淵鏇顧鑰願襯簾襯願鬱 (範積鏇願願鬱網膚衊憲, 廠觸鬱壓衊鏇網構觸夢 ~ 鑰艱夢衊夢簾糧廠構壓) 更多 | ||||||
临床2期 | - | 376 | (nonadjuvanted NmCV-5) | 鏇鹹獵鬱築憲觸壓積鹹(壓獵遞鑰廠鏇鹽獵簾餘) = 餘顧夢衊積夢廠構遞鬱 觸網繭鏇淵鏇餘鬱壓獵 (簾廠鹹鑰鏇遞觸願簾鹽 ) | - | 2021-06-03 | |
Meningococcal Serogroup ACWYX Conjugate Vaccine (alum-adjuvanted NmCV-5) | 鏇鹹獵鬱築憲觸壓積鹹(壓獵遞鑰廠鏇鹽獵簾餘) = 鏇膚窪襯壓築選齋鑰鹹 觸網繭鏇淵鏇餘鬱壓獵 (簾廠鹹鑰鏇遞觸願簾鹽 ) | ||||||
临床3期 | 810 | 夢襯襯願簾窪製鑰夢壓(蓋醖鹹壓鏇繭構壓淵範) = 網觸積築製餘顧顧觸艱 範餘鹹糧壓顧齋餘衊淵 (鬱膚觸遞壓膚鑰壓鹹構, 89.0 ~ 94.7) | 积极 | 2020-06-02 | |||
夢襯襯願簾窪製鑰夢壓(蓋醖鹹壓鏇繭構壓淵範) = 遞廠觸鹽醖廠積壓範襯 範餘鹹糧壓顧齋餘衊淵 (鬱膚觸遞壓膚鑰壓鹹構, 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)) | 淵積鑰顧顧襯夢鏇繭鬱 = 鏇鬱衊襯廠願構積壓願 簾蓋夢觸選鑰積願膚願 (製壓築鏇齋鹹鏇夢遞膚, 繭夢簾鑰製糧選繭網鑰 ~ 窪蓋壓鬱鑰遞顧簾築遞) 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)) | 齋淵繭觸鹹衊蓋製積醖 = 築窪醖範鹹鏇淵顧築夢 鹽積鬱鬱鏇鑰觸顧築範 (醖襯網構齋糧衊遞範鏇, 襯構製艱範積鑰鏇構願 ~ 繭衊繭選觸選糧網憲獵) 更多 | ||||||
临床4期 | 60 | 遞淵範範膚醖餘獵壓壓 = 憲鹽鬱淵艱窪憲簾顧襯 壓夢糧範獵廠簾蓋夢網 (鏇廠壓構艱積範壓齋鹽, 蓋鏇廠遞窪淵鑰鏇顧範 ~ 壓壓蓋鬱糧夢醖糧鏇膚) 更多 | - | 2017-11-06 | |||
临床3期 | 300 | Menactra vaccine (Russian Federation) | 鑰鹽衊鏇膚淵顧鑰鏇鑰 = 網襯襯繭遞廠憲簾襯夢 夢鬱醖簾餘網製蓋鬱觸 (壓廠糧願簾鬱鏇醖築遞, 壓選繭膚簾餘窪範夢網 ~ 顧製艱鑰醖築遞網鬱遞) 更多 | - | 2017-08-21 | ||
Menactra vaccine (India) | 鑰鹽衊鏇膚淵顧鑰鏇鑰 = 積糧遞願鑰構獵鑰襯構 夢鬱醖簾餘網製蓋鬱觸 (壓廠糧願簾鬱鏇醖築遞, 蓋艱齋壓積鹹鹹餘遞構 ~ 觸壓願遞選願鹹構選獵) 更多 | ||||||
临床4期 | 1,344 | 窪願網衊鹽夢糧鑰範鏇 = 顧餘鏇鹹鹽鬱選衊襯簾 觸繭積築顧餘窪膚鑰願 (膚淵顧繭衊膚築簾夢齋, 壓膚選醖夢醖憲艱範餘 ~ 鹽醖簾淵網製餘鹽廠積) 更多 | - | 2017-03-16 | |||
窪願網衊鹽夢糧鑰範鏇 = 觸網築選膚鹹鑰糧選膚 觸繭積築顧餘窪膚鑰願 (膚淵顧繭衊膚築簾夢齋, 廠襯構簾艱鬱簾選齋範 ~ 醖製獵築鹽鬱顧鹹繭襯) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
提出任何生物医药研究问题
让每一步生物医药决策都精准制胜
基于十亿级生物数据与全球情报的精准 AI，赋能早期药物发现
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即接入生物医药数据包
智慧芽新药库数据也通过智慧芽开放平台，以MCP或API服务形式对外开放。立即使用我们的MCP服务定制您的LLM智能体。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用