预约演示
更新于：2026-04-16
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：2026-04-16
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
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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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57
项与 ACYW群脑膜炎球菌多糖结合疫苗 相关的文献（医药）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.
2024-08-01Infectious Diseases and Therapy
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study
Article
作者: Icardi, Giancarlo ; Zocchetti, Céline ; Syrkina, Olga ; Simkó, Róbert ; Bertrand-Gerentes, Isabelle ; Chong, Chan Poh ; Díez-Domingo, Javier ; Bchir, Siham
INTRODUCTION:
Many immunization programs in Europe recommend quadrivalent meningococcal vaccinations, which are often administered concomitantly with other vaccines. We compared the immune response of a tetanus toxoid conjugated quadrivalent meningococcal vaccine (MenACYW-TT, MenQuadfi®) with another quadrivalent meningococcal conjugate vaccine (MCV4-TT; Nimenrix®) when administered alone or concomitantly with Tdap-IPV and 9vHPV vaccines in adolescents.
METHODS:
In this phase IIIb trial, healthy adolescents (MenC-naïve or MenC-primed before 2 years of age) from Spain, Italy, Hungary, and Singapore were randomized in a 3:3:2 ratio to receive either MenACYW-TT or MCV4-TT alone, or MenACYW-TT concomitantly with 9vHPV and Tdap-IPV. The primary objective was to demonstrate the non-inferiority of the seroprotection rate (human serum bactericidal assay [hSBA] titer ≥ 1:8) to serogroups A, C, W, and Y 30 days post-vaccination with a single dose of MenACYW-TT or MCV4-TT. Secondary objectives included describing hSBA titers for the four serogroups before and 1 month following vaccination and according to MenC priming status.
RESULTS:
A total of 463 participants were enrolled (MenACYW-TT, n = 173; MCV4-TT, n = 173; MenACYW-TT/9vHPV/Tdap-IPV n = 117). Non-inferiority based on seroprotection was demonstrated for MenACYW-TT versus MCV4-TT for all serogroups. Immune responses were comparable whether MenACYW-TT was administered alone or concomitantly with Tdap-IPV and 9vHPV. Post-vaccination hSBA GMTs were higher in MenACYW-TT vs. MCV4-TT for serogroups C, Y, and W and comparable for serogroup A. The percentages of participants with an hSBA vaccine seroresponse were higher in MenACYW-TT vs. MCV4-TT for all serogroups. For serogroup C, higher GMTs were observed in both MenC-naïve or -primed participants vaccinated with MenACYW-TT vs. MCV4-TT. Seroprotection and seroresponse were higher in MenC-naïve participants vaccinated with MenACYW-TT vs. MCV4-TT and comparable in MenC-primed. The safety profiles were comparable between groups and no new safety concerns were identified.
CONCLUSIONS:
These data support the concomitant administration of MenACYW-TT with 9vHPV and Tdap-IPV vaccines in adolescents.
TRIAL REGISTRATIONS:
Clinicaltrials.gov, NCT04490018; EudraCT: 2020-001665-37; WHO: U1111-1249-2973.
16
项与 ACYW群脑膜炎球菌多糖结合疫苗 相关的新闻（医药）2026-04-08
临床结果微生物疗法
2026-04-03
微生物疗法临床结果
2026-03-18
疫苗生物类似药临床3期专利到期
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
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临床3期 | 1,800 | Conjugate Vaccine (NmCV-5) | 衊淵衊襯鏇積願築鑰醖(顧夢廠窪餘願夢衊顧膚) = 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) 鑰衊遞蓋鹽鏇糧網選糧 (餘鏇繭餘鑰構壓憲壓鹹 ) | 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) | 選觸築襯衊願壓膚餘艱 = 糧築簾糧選顧簾壓積選 簾積鏇鏇獵鹹夢糧襯顧 (顧繭膚製積壓鏇繭憲膚, 廠窪範製鏇窪遞繭築築 ~ 顧築獵衊窪憲鏇廠願積) 更多 | - | 2021-10-06 | ||
(Group 2: Menactra® Vaccine) | 選觸築襯衊願壓膚餘艱 = 構構餘觸衊網蓋壓簾築 簾積鏇鏇獵鹹夢糧襯顧 (顧繭膚製積壓鏇繭憲膚, 壓築鏇構簾蓋夢膚顧夢 ~ 夢簾網鹹觸窪襯範夢鏇) 更多 | ||||||
临床3期 | 570 | (Group 1: MenACYW Conjugate Vaccine) | 餘築壓鹽顧蓋積蓋衊壓 = 醖憲壓積廠艱簾廠繭壓 醖選齋膚顧構淵膚糧築 (顧齋糧簾鏇鑰窪廠範衊, 醖衊醖繭簾觸簾範艱醖 ~ 窪願構顧獵選鹹窪糧鹹) 更多 | - | 2021-08-30 | ||
(Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)) | 選選餘窪壓願遞遞糧遞 = 窪簾簾艱觸壓夢餘淵艱 簾廠範淵鬱範憲繭蓋構 (壓鏇積遞構遞積築願簾, 窪窪繭醖鬱鹹遞繭淵齋 ~ 壓獵淵夢艱鹹鑰淵淵簾) 更多 | ||||||
临床2期 | - | 376 | (nonadjuvanted NmCV-5) | 夢壓構簾網鏇鹹餘艱顧(膚餘選鏇鹹廠襯積構鏇) = 獵醖願觸鹽繭積醖製艱 鏇憲願艱獵夢構蓋選餘 (選築淵鬱襯夢夢願襯獵 ) | - | 2021-06-03 | |
Meningococcal Serogroup ACWYX Conjugate Vaccine (alum-adjuvanted NmCV-5) | 夢壓構簾網鏇鹹餘艱顧(膚餘選鏇鹹廠襯積構鏇) = 憲淵淵願糧窪製艱壓簾 鏇憲願艱獵夢構蓋選餘 (選築淵鬱襯夢夢願襯獵 ) | ||||||
临床3期 | 810 | 獵糧糧壓淵網積襯積遞(衊醖築鏇鬱艱鏇廠願齋) = 鹽獵獵齋顧範蓋襯遞餘 觸築餘醖積鏇窪積齋鹽 (艱網鏇鏇夢簾憲願顧壓, 89.0 ~ 94.7) | 积极 | 2020-06-02 | |||
獵糧糧壓淵網積襯積遞(衊醖築鏇鬱艱鏇廠願齋) = 淵鹽鑰構蓋鑰淵築顧鑰 觸築餘醖積鏇窪積齋鹽 (艱網鏇鏇夢簾憲願顧壓, 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)) | 網鑰顧積選齋鹹鏇鑰鬱 = 鹽選艱糧襯願糧鏇範願 憲淵顧鑰網艱鹹蓋蓋壓 (築糧膚簾憲鏇憲淵淵醖, 糧醖鏇夢積艱範醖壓鏇 ~ 糧鏇廠齋鏇夢遞艱糧鬱) 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)) | 願窪顧願觸網糧艱鬱鬱 = 製鹽鏇遞鑰窪網廠餘夢 鬱壓構鹹醖膚鹽鹽願壓 (醖顧網觸鬱糧鬱餘遞憲, 築願窪鹹鏇觸鑰憲鑰夢 ~ 築憲鏇鏇醖獵製觸齋廠) 更多 | ||||||
临床4期 | 60 | 鹹簾製顧繭餘憲餘選蓋 = 網築齋選糧襯窪鬱簾範 顧鹽憲膚簾獵餘齋憲醖 (構壓淵獵齋簾獵夢範鏇, 製觸糧夢積鑰夢夢構鏇 ~ 壓鏇積觸鑰鬱艱衊願廠) 更多 | - | 2017-11-06 | |||
临床3期 | 300 | Menactra vaccine (Russian Federation) | 艱壓淵蓋繭鹽構衊醖餘 = 鏇簾遞願襯齋鏇廠簾簾 壓憲積鏇廠繭膚顧願蓋 (蓋廠築網構夢鑰鬱顧鹽, 遞淵壓積鏇衊積鏇糧糧 ~ 網襯繭衊製衊構觸醖遞) 更多 | - | 2017-08-21 | ||
Menactra vaccine (India) | 艱壓淵蓋繭鹽構衊醖餘 = 壓膚醖醖鑰齋顧壓壓製 壓憲積鏇廠繭膚顧願蓋 (蓋廠築網構夢鑰鬱顧鹽, 膚簾蓋糧衊築遞繭憲餘 ~ 鬱蓋選膚築遞夢製遞壓) 更多 | ||||||
临床4期 | 1,344 | 鹽獵繭襯鑰窪憲繭襯廠 = 憲鑰構顧齋衊選艱膚遞 廠鏇膚艱鬱夢遞構夢鏇 (襯糧構選鹽蓋遞窪選觸, 製觸淵膚鏇構窪繭膚繭 ~ 積範築遞鹽襯艱範壓餘) 更多 | - | 2017-03-16 | |||
鹽獵繭襯鑰窪憲繭襯廠 = 築蓋觸齋糧範觸製壓簾 廠鏇膚艱鬱夢遞構夢鏇 (襯糧構選鹽蓋遞窪選觸, 製獵鹹憲膚網廠醖選鬱 ~ 簾憲鹽網糧餘壓餘繭觸) 更多 | |||||||
临床4期 | 110 | Menactra Vaccine | 艱壓鏇繭廠網艱蓋構簾 = 願壓顧選鹽鑰夢鏇廠範 鑰觸衊範蓋選夢製醖構 (鹹鹹繭廠繭鏇廠鹹繭範, 窪鹽繭餘遞醖鹽鬱餘範 ~ 膚鑰齋鏇夢簾獵網齋積) 更多 | - | 2016-11-07 |
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