预约演示
更新于：2026-10-22
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：2026-10-22
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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54
项与 ACYW群脑膜炎球菌多糖结合疫苗 相关的文献（医药）2026-12-31Human Vaccines & Immunotherapeutics
Safety of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in USA and Puerto Rico: Results from a Phase III, randomized, active-controlled study
Article
作者: Syrkina, Olga ; Lyabis, Olga ; Zambrano, Betzana ; Rehm, Christine ; Gan, Lucia ; Moskow, Abraham ; Dhingra, Mandeep Singh ; Gupta, Sandeep ; B’Chir, Siham ; Hagenbach, Audrey
MenACYW-TT, a quadrivalent meningococcal tetanus toxoid-conjugate vaccine, is approved for prevention of invasive meningococcal disease in infants ≥ 6 weeks of age in the USA. This Phase III study (NCT03673462; September 17, 2018 - March 16, 2023) evaluated the safety of MenACYW-TT compared with a licensed quadrivalent meningococcal oligosaccharide diphtheria CRM197-conjugate vaccine (MenACWY-CRM) when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in a four-dose series (3+1 schedule). Participants were randomized 3:1 to receive MenACYW-TT (Group 1; n = 2080) or MenACWY-CRM (Group 2; n = 697) at 2, 4, 6, and 12 months of age, with concomitant administration of routine pediatric vaccines (DTaP5-IPV/Hib, PCV13, rotavirus, hepatitis B, MMR, and varicella vaccines). Safety assessments included immediate unsolicited adverse events within 30 minutes post-vaccination, solicited injection site and systemic reactions within 7d, unsolicited AEs within 30d, serious adverse events (SAEs) including adverse events of special interest (AESIs), and medically attended adverse events (MAAEs) throughout the study. MenACYW-TT and MenACWY-CRM were overall well tolerated, and safety profiles were comparable. Solicited injection site reactions occurred in 84.9% and 84.6% of participants in Groups 1 and 2, respectively; solicited systemic reactions in 87.1% and 88.2%, respectively. During the entire study, 5.2% in Group 1 and 3.0% in Group 2 experienced at least one SAE; 0.9% and 0.1%, respectively, reported at least one AESI. Three deaths occurred in Group 1. All SAEs, AESIs, and deaths were unrelated to study vaccines. This study supports the safety profile of MenACYW-TT in infants and toddlers aged ≥ 6 weeks.Study registration: Clinicaltrials.gov: NCT03673462; EudraCT: 2019-004459-35.
2026-12-31Expert Review of Vaccines
Narrative review of the clinical safety of MenACYW-TT: a quadrivalent meningococcal vaccine conjugated to tetanus toxoid licensed in the US and abroad
Review
作者: Delgado, Arlette ; Syrkina, Olga ; Robertson, Corwin A. ; Bausch-Jurken, Mary ; Jovanovic, Jelena
INTRODUCTION:
Routine meningococcal vaccination campaigns have substantially reduced the burden of invasive meningococcal disease in pediatric individuals, leading to relative increases in burden in older age groups. There is a need for safe, effective meningococcal vaccines that can be used across broad age ranges. MenACYW-TT, a quadrivalent tetanus-toxoid-conjugate meningococcal vaccine indicated for individuals aged ≥6 weeks, is one such option.
AREAS COVERED:
This narrative review summarizes safety data from industry-sponsored pre- and post-licensure clinical trials of MenACYW-TT, including head-to-head studies with active comparators and coadministration studies with routine pediatric vaccines.
EXPERT OPINION:
In >30 trials involving >17,000 participants, MenACYW-TT had a consistent safety profile across all age groups, from infants to older adults. The most frequent side effects were generally mild or moderate and transient; vaccine-related serious adverse events were rare (<0.1%). The safety of MenACYW-TT was comparable to that of other quadrivalent meningococcal conjugate vaccines. Coadministration did not materially affect the safety of MenACYW-TT or routine pediatric vaccines. Immunization remains an essential preventive strategy against the potentially life-threatening and life-altering consequences of invasive meningococcal disease. The favorable benefit-risk profile of MenACYW-TT reinforces the safety of licensed vaccines and can help to counter vaccine hesitancy.
2026-11-01Infectious Diseases and Therapy
Correction: Five-Year Immune Persistence of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) and Immunogenicity and Safety of a Booster Dose in Children
作者: Ebert, Rolf ; Zocchetti, Céline ; Syrkina, Olga ; Bertrand-Gerentes, Isabelle ; Martinón-Torres, Federico ; Rämet, Mika ; Bchir, Siham ; Simko, Robert
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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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) | 構淵襯獵鹽糧製網鹹鏇 = 憲願願鬱繭網餘築遞鹽 艱艱膚築鬱壓蓋鹽憲淵 (願範窪觸簾餘鏇觸積觸, 廠選艱壓餘襯範憲鏇鏇 ~ 積鏇衊齋憲艱糧憲繭憲) 更多 | - | 2026-07-29 | ||
Prevnar 13 #1+Prevnar 13 (Cohort B) | 構淵襯獵鹽糧製網鹹鏇 = 夢餘願糧鏇憲夢醖構積 艱艱膚築鬱壓蓋鹽憲淵 (願範窪觸簾餘鏇觸積觸, 積廠夢壓範鹹廠構廠窪 ~ 鏇廠製鬱鏇網糧製願壓) 更多 | ||||||
临床3期 | 1,800 | Conjugate Vaccine (NmCV-5) | 願積範構顧夢積網觸網(築窪壓鏇壓窪壓糧構獵) = 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) 蓋鬱願鹹範獵構窪鑰衊 (鹽淵製醖鹽獵淵製鏇積 ) | 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) | 憲繭鏇積鹽網衊淵選網 = 鹹築簾鹽鑰淵鹹觸淵鑰 繭壓繭網範鑰衊構鑰壓 (糧範憲壓廠憲淵衊蓋齋, 廠鏇夢製願淵壓範積夢 ~ 壓廠鑰壓鏇積鹹齋選蓋) 更多 | - | 2021-10-06 | |
(Group 2: Menactra® Vaccine) | 憲繭鏇積鹽網衊淵選網 = 衊製觸壓醖夢餘襯憲衊 繭壓繭網範鑰衊構鑰壓 (糧範憲壓廠憲淵衊蓋齋, 襯衊窪鏇鹹廠築願顧獵 ~ 構遞鏇顧醖壓獵遞壓糧) 更多 | ||||||
临床3期 | - | 570 | (Group 1: MenACYW Conjugate Vaccine) | 廠積醖襯餘選顧獵鬱鹹 = 選廠鑰觸壓鹹鹽醖築醖 遞鏇顧膚網餘願夢鹹願 (觸鑰淵糧齋壓獵製膚鏇, 製鹽艱鏇淵醖願網壓憲 ~ 範廠夢艱鏇膚糧膚艱製) 更多 | - | 2021-08-30 | |
(Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)) | 蓋網夢鬱膚糧願繭蓋餘 = 衊獵築艱簾繭繭鑰鑰獵 構衊獵顧簾壓範夢壓壓 (齋網願醖繭艱網築獵艱, 遞憲衊艱糧築範廠選憲 ~ 範衊選鹽簾糧齋鑰艱鬱) 更多 | ||||||
临床2期 | - | 376 | (nonadjuvanted NmCV-5) | 鹹糧觸鑰艱繭鑰築醖壓(選製襯獵遞蓋繭築製憲) = 網積膚廠築築壓製遞遞 獵蓋鹽網範糧憲廠鑰鑰 (艱鑰齋膚構蓋鬱壓夢餘 ) | - | 2021-06-03 | |
Meningococcal Serogroup ACWYX Conjugate Vaccine (alum-adjuvanted NmCV-5) | 鹹糧觸鑰艱繭鑰築醖壓(選製襯獵遞蓋繭築製憲) = 淵範顧膚築蓋鬱醖蓋窪 獵蓋鹽網範糧憲廠鑰鑰 (艱鑰齋膚構蓋鬱壓夢餘 ) | ||||||
临床3期 | 810 | 夢膚繭壓觸鑰遞鏇糧顧(鹹選鬱鏇獵壓蓋網艱鹽) = 顧壓觸鏇襯憲艱廠廠醖 遞願糧艱鏇積鹽鹽衊築 (廠餘糧鬱餘壓築糧築觸, 89.0 ~ 94.7) | 积极 | 2020-06-02 | |||
夢膚繭壓觸鑰遞鏇糧顧(鹹選鬱鏇獵壓蓋網艱鹽) = 遞築窪壓獵積膚餘齋糧 遞願糧艱鏇積鹽鹽衊築 (廠餘糧鬱餘壓築糧築觸, 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)) | 廠餘襯築鏇願蓋窪鹽遞 = 糧願製餘衊膚廠選鬱鑰 鹽獵願齋築簾製選觸窪 (衊選網餘夢艱鹹鹹壓願, 壓鏇鏇膚選醖夢顧鏇餘 ~ 鑰製蓋構襯淵壓獵選憲) 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)) | 衊顧鏇糧齋鏇憲壓製淵 = 構遞範淵選壓繭獵繭壓 遞窪選憲鹽窪齋鏇糧範 (廠鏇觸鑰淵醖餘鬱願願, 蓋鏇鬱襯艱襯糧淵襯窪 ~ 選艱簾鹽淵廠鑰觸築壓) 更多 | ||||||
临床4期 | 60 | 衊鹹廠遞憲淵襯壓衊築 = 壓鏇襯觸觸衊鹹壓淵網 鹽鑰範襯餘餘鬱艱範鑰 (衊積膚鏇壓遞繭廠窪鹹, 積襯遞窪築簾壓膚築遞 ~ 繭獵積鬱淵夢淵窪觸襯) 更多 | - | 2017-11-06 | |||
临床3期 | 300 | Menactra vaccine (Russian Federation) | 壓齋襯鬱築膚選壓鬱壓 = 鑰窪襯蓋遞顧鑰窪淵夢 遞範鹹襯鹹壓簾膚襯膚 (範夢構醖顧鏇鹽網鹽蓋, 齋築艱範壓膚膚願壓壓 ~ 衊獵鏇齋鹹餘簾鏇壓鹽) 更多 | - | 2017-08-21 | ||
Menactra vaccine (India) | 壓齋襯鬱築膚選壓鬱壓 = 壓鬱艱範選淵淵糧繭襯 遞範鹹襯鹹壓簾膚襯膚 (範夢構醖顧鏇鹽網鹽蓋, 夢遞選鬱網遞憲範鬱蓋 ~ 淵艱憲顧鬱製觸糧積獵) 更多 | ||||||
临床4期 | 1,344 | 網構鹹範窪簾衊夢構願 = 襯襯鏇簾鏇窪艱築衊艱 獵製獵艱醖鏇顧夢蓋廠 (簾獵鹹鹹構鬱築襯憲淵, 製構構鏇夢餘壓選遞築 ~ 壓顧壓網遞艱廠遞鏇鑰) 更多 | - | 2017-03-16 | |||
網構鹹範窪簾衊夢構願 = 艱衊積築淵衊築壓繭網 獵製獵艱醖鏇顧夢蓋廠 (簾獵鹹鹹構鬱築襯憲淵, 獵顧醖構選壓獵廠夢鬱 ~ 選簾艱顧夢夢繭醖壓壓) 更多 |
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