ACYW135群脑膜炎球菌结合疫苗(赛诺菲)(Meningococcal vaccine groups A C Y W-135 conjugate (second generation)(Sanofi))

概要

基本信息

药物类型

预防性疫苗、多价疫苗、结合疫苗

别名

Men Quad TT、MenACYW conjugate vaccine、Meningococcal (Groups A, C, Y, W) Conjugate Vaccine

+ [8]

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Sanofi Pasteur SASanofi-Aventis Australia Pty Ltd.

+ [3]

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (2020-04-23),

脑膜炎球菌感染

最高研发阶段(中国)临床3期

特殊审评-

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关联

30

项与 ACYW135群脑膜炎球菌结合疫苗(赛诺菲) 相关的临床试验

NCT07135986

/ Recruiting临床3期

A Phase 3, Modified Double-blind, Multi-center Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents (2 to 17 Years of Age) in China

This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China.
Study details include:
* The study duration will be approximately 180 days.
* The vaccination visit will be Visit 1.
* The visit frequency will be 2 on-site visits with a 30-day interval. A safety visit/telephone call is planned on the ninth day after the vaccination for all groups; a safety follow-up telephone call is planned for all groups 180 days post the last vaccination.

开始日期2025-09-26

申办/合作机构

Sanofi

NCT06284915

/ Active, not recruiting临床3期

A Parallel-group, Prevention, Phase III, Modified Double-blind, 2-arm, Study to Investigate the Immunogenicity and Describe the Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared With Nimenrix® When Administered in a 1+1 Schedule in Healthy Infants and Toddlers at 6 and 12 Months of Age

This study is conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study is designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination schedule), with the first dose (priming dose) being given at 6-7 months of age to MenACWY- naïve healthy infants and the second dose (booster dose) given at 12-13 months of age. This study will also describe additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants.

开始日期2024-03-19

申办/合作机构

Sanofi Pasteur SA

NCT06228586

/ Completed临床3期

A Phase III, Open-label, Single-center Study to Describe the Immunogenicity and Safety of a Single Dose of MenACYW Conjugate Vaccine in Participants Aged 12 Months and Older in Vietnam

The MEQ00074 study was a Phase III, open-label, single-center study aimed at describing the immunogenicity and safety of a single dose of investigational quadrivalent Meningococcal Polysaccharide (serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine (MenACYW conjugate vaccine) in participants aged 12 months and older in Vietnam.
The primary objectives of the study were:
* To describe the antibody responses to meningococcal serogroups A, C, W, and Y before and 30 days after the administration of a single dose of MenACYW conjugate vaccine
* To describe the safety profile of a single dose of MenACYW conjugate vaccine The duration of each participant's participation will be approximately 30 to 44 days.

开始日期2024-01-18

申办/合作机构

Sanofi Pasteur SA

100 项与 ACYW135群脑膜炎球菌结合疫苗(赛诺菲) 相关的临床结果

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100 项与 ACYW135群脑膜炎球菌结合疫苗(赛诺菲) 相关的转化医学

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100 项与 ACYW135群脑膜炎球菌结合疫苗(赛诺菲) 相关的专利（医药）

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107

项与 ACYW135群脑膜炎球菌结合疫苗(赛诺菲) 相关的文献（医药）

2025-06-01·Infectious Diseases and Therapy

Correction: Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study

作者: Icardi, Giancarlo ; Simkó, Róbert ; Syrkina, Olga ; Zocchetti, Céline ; Bertrand-Gerentes, Isabelle ; Chong, Chan Poh ; Díez-Domingo, Javier ; Bchir, Siham

2025-05-01·PEDIATRIC 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.

2025-04-01·LANCET INFECTIOUS DISEASES

Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine versus a quadrivalent meningococcal conjugate vaccine in adults in India: an observer-blind, randomised, active-controlled, phase 2/3 study

Article

作者: Mallya, Asha ; Panigrahi, Sandeep Kumar ; Parulekar, Varsha ; Munshi, Renuka ; Gogtay, Nithya J ; Venkatarao, Epari ; Patil, Rakesh ; Sahoo, Jyotiranjan ; Kawade, Anand ; Dharmadhikari, Abhijeet ; S, Ravish H ; Kulkarni, Prasad S ; Raut, Abhishek ; Singh, Kiranjit ; Gagnon, Luc ; Kumari, Nitu ; Dhere, Rajeev M ; Raj, Jeffrey P ; Poonawalla, Cyrus S ; Garg, B S ; Chaudhari, Vijaya L ; Gairola, Sunil ; Pisal, Sambhaji S ; Kale, Sameer ; Kapse, Dhananjay ; Bavdekar, Ashish ; Vengadakrishnan, K ; Maliye, Chetna ; Kohli, Sunil ; Gensale, Tania ; Saxena, Unnati ; Surendran, Jithin

BACKGROUND:

Meningococcal disease remains an important public health problem globally. We assessed the non-inferiority and the lot-to-lot consistency of a pentavalent meningococcal ACYWX conjugate vaccine (NmCV-5; Serum Institute of India, Pune, India) versus a quadrivalent meningococcal ACWY conjugate vaccine (MenACWY-D) in healthy adults.

METHODS:

In this observer-blind, randomised, active-controlled, phase 2/3 study, healthy adults aged 18-85 years were recruited from nine hospitals across seven cities in India. Participants were grouped by age (age 18-29, 30-60, and 61-85 years), and within each age group they were randomly assigned (3:1) to receive either NmCV-5 or MenACWY-D (Sanofi Pasteur). In the age 18-29 years group, participants were additionally randomly assigned (1:1:1:1) to either lot A, lot B, or lot C of NmCV-5 or MenACWY-D. Block randomisation was used (block sizes of 4, 8, and 12). Study participants and study personnel were masked to treatment assignment. Participants received either a 0·5 mL dose of NmCV-5, containing 5 μg each of conjugated A, C, W, Y, and X polysaccharides, or 0·5 mL MenACWY-D, containing 4 μg of each of conjugated A, C, W, and Y polysaccharides. Vaccinations were administered intramuscularly in the deltoid muscle. The primary outcomes were seroresponse (non-inferiority margin of -10%) and geometric mean titres (GMTs; non-inferiority margin of 0·5) in all participants, and lot-to-lot consistency of NmCV-5 (in participants aged 18-29 years; consistency was shown if the geometric mean ratio [GMR] 95% CIs were within the limit interval of 0·5 to 2). For non-inferiority, serogroup X immune response in the NmCV-5 group was compared with the lowest immune response among serogroups A, C, W, and Y in the MenACWY-D group. Immunogenicity was assessed with a serum bactericidal activity assay that used baby rabbit serum as the complement (rSBA) on days 1 and 29 in the modified per-protocol population (including all participants who were randomly assigned, received vaccine, had a post-vaccination rSBA measurement up to 121 days after vaccination, and no major protocol violations). Solicited events were collected for 7 days and serious adverse events were collected for 180 days, and assessed in the safety population (all participants who received vaccination). This study is registered with ClinicalTrials.gov, NCT04358731, and CTRI, CTRI/2019/12/022436, and is now complete.

FINDINGS:

Between Dec 27, 2019, and Sept 19, 2020, 1712 individuals were screened, of whom 1640 were randomly assigned and received NmCV-5 (n=1233) or MenACWY-D (n=407; mean age 26·4 years [SD 12·2], 551 [33·6%] of 1640 were female, and 1089 [66·4%] were male). 1441 participants were aged 18-29 years (362 received lot A, 360 received lot B, and 361 received lot C of NmCV-5 and 357 received MenACWY-D, with one participant mis-randomised by age group and excluded from lot-to-lot consistency analysis). Non-inferiority of NmCV-5 against MenACWY-D was met in terms of seroresponse rates and GMT ratios for all five serogroups. The seroresponse rates were 84·3% (97·5% CI 81·7 to 86·7; serogroup A) or higher in the NmCV-5 group and 54·5% (48·5 to 60·3; serogroup A) or higher in the MenACWY-D group, with the difference in the seroresponse rate between vaccine groups ranging from 0·2 (97·5% CI -2·2 to 2·6) for serogroup W to 29·8 (24·4 to 35·2) for serogroup A. GMTs on day 29 were 7016·9 (97·5% CI 6475·7 to 7603·4; serogroup Y) or higher in the NmCV-5 group and 3646·8 (3188·2 to 4171·5; serogroup Y) or higher in the MenACWY-D group, with GMT ratios between vaccine groups for serogroups A, C, Y, and W ranging from 1·9 (97·5% CI 1·5-2·3) for serogroup W to 2·5 (2·2-2·8) for serogroup A. NmCV-5 induced robust immune responses against serogroup X. Lot-to-lot consistency of NmCV-5 was found for all five serogroups, with 95% CIs for the GMT ratio for each pair of lots being between 0·5 and 2: the lowest lower bound and the highest upper bound of the 95% CI for the GMR between NmCV-5 lot A and lot B were 0·6 and 1·4, between lot A and lot C were 0·7 and 1·6, and between lot B and lot C were 0·8 and 1·6, respectively, for any of the five serogroups. At least one solicited adverse event was reported by 527 (42·7%) of 1233 participants in the NmCV-5 group and 142 (34·9%) of 407 in the MenACWY-D group. No serious adverse events occurred that were determined to be causally related to vaccination.

INTERPRETATION:

NmCV-5 was non-inferior to MenACWY-D in terms of seroresponse and GMTs, was safe, and demonstrated lot-to-lot consistency. NmCV-5 is prequalified by WHO and was rolled out in the African meningitis belt in April, 2024.

FUNDING:

Serum Institute of India.

16

项与 ACYW135群脑膜炎球菌结合疫苗(赛诺菲) 相关的新闻（医药）

2025-08-07

·医药地理

2025 H1全球药企财报全景：创新驱动增长，国际化与管线布局成关键

在全球医药行业持续变革的背景下，2025年上半年各大制药企业的财务表现不仅反映了各自战略执行的有效性，也揭示了行业发展的整体趋势。本文通过对诺华、诺和诺德、阿斯利康、百济神州及赛诺菲五家代表性企业2025年上半年财报的系统梳理，全面剖析当前全球医药产业的竞争格局。数据显示，创新药已成为药企业绩增长的核心引擎，而国际化能力则成为企业分化的关键因素。与此同时，以ADC、GLP-1类药物为代表的新技术平台和明星赛道正在重塑行业价值分配，中国药企在全球医药创新版图中的角色也日益凸显。透过这些头部企业的财务表现与战略动向，我们可以一窥医药行业未来的发展方向与投资机会。诺华：核药与创新疗法双轮驱动，中国区稳健增长诺华在2025年上半年展现了强劲的业绩表现，公司净销售额达272.87亿美元，同比增长12%，净利润76.33亿美元，同比大增29%。这一增长主要得益于公司在核心治疗领域的深度布局和多个重磅产品的出色表现。核心治疗领域表现方面，诺华专注于心血管肾脏代谢、免疫学、神经科学和肿瘤学四大板块，上半年分别收入51.73亿美元、49.58亿美元、27.59亿美元和81.99亿美元。其中，肿瘤业务增长最为显著，主要得益于Pluvicto等核药产品的强劲表现。明星产品方面，Entresto（沙库巴曲缬沙坦）仍为诺华贡献了最大营收，上半年销售额达46.18亿美元（+22%），全年有望突破百亿美元大关。Cosentyx（司库奇尤单抗）和Kisqali（瑞波西利）分别以31.63亿美元（+11%）和21.33亿美元（+59%）的销售额位居第二和第三位。第二季度及上半年排名前20的品牌净销售额图源：诺华 2025 H1 财报如今核药业务成为诺华增长的重要引擎，Pluvicto上半年销售额达8.25亿美元（+26%），自2022年上市以来持续高速增长，2024年首次突破10亿美元。另一款核药Lutathera也贡献了4亿美元收入（+16%），两款核药合计收入12.25亿美元。Pluvicto在中国的上市申请已获受理，有望进一步拓展亚洲市场。在中国市场，诺华上半年收入22亿美元，同比增长8%，表现稳健。下半年，公司伊普可泮和阿思尼布有望在中国斩获新适应症，将进一步巩固其在中国市场的地位。图源：诺华 2025 H1 财报诺华在研发创新方面持续加码，特别是在放射配体疗法领域。公司近期与Ratio Therapeutics达成合作协议，开发靶向SSTR2的放射性候选药物，潜在交易金额高达7.45亿美元。这一布局将进一步强化诺华在核药领域的领先优势，为未来增长奠定基础。诺和诺德：司美格鲁肽主导市场，仍面临增长压力诺和诺德2025年上半年营收达228.54亿美元（1549.44亿丹麦克朗），同比增长18%，继续领跑代谢疾病领域。然而，公司下调了全年增长预期至8-14%，反映出GLP-1市场竞争加剧的挑战。图源：诺和诺德财报司美格鲁肽系列产品仍是诺和诺德的绝对主力，上半年销售额合计166.32亿美元，占公司总营收的73%。其中：降糖注射版Ozempic销售额95.17亿美元（+15%），口服版Rybelsus销售额16.74亿美元（+5%），减肥版Wegovy销售额54.41亿美元（+78%）。在中国市场，诺和诺德上半年收入14.62亿美元（99.10亿丹麦克朗），同比增长6%。Wegovy自2024年11月商业化以来表现亮眼，上半年销售额达1.24亿美元，而Ozempic在中国市场则出现5%的下滑。市场竞争方面，礼来替尔泊肽（tirzepatide）成为司美格鲁肽最强劲的竞争对手，2025年Q1销售额达61.5亿美元（+160%）。此外，非品牌复合GLP-1药物的兴起也对诺和诺德的定价能力构成挑战。尽管面临挑战，诺和诺德在代谢疾病领域的领导地位依然稳固。随着Wegovy的MASH适应症可能在2025年下半年获批，以及更高剂量制剂（7.2mg）的推出，公司有望维持其在GLP-1市场的主导地位。阿斯利康：肿瘤业务引领增长，Enhertu成ADC领域标杆阿斯利康2025年上半年总营收达280.45亿美元，同比增长11%，展现出稳健的增长态势。公司研发投入67.07亿美元，同比增长16%，彰显对创新的持续重视。图源：阿斯利康财报区域表现方面，美国市场收入119.70亿美元（+12%），仍是最大单一市场；欧洲市场收入58.25亿美元（+8%）；新兴市场收入76.97亿美元（+12%），其中中国区收入35.15亿美元（+5%）。图源：阿斯利康财报肿瘤业务作为阿斯利康的支柱，上半年贡献119.55亿美元收入（+16%）。主要驱动力包括：Tagrisso（奥希替尼）：34.88亿美元（+10%）。Imfinzi（度伐利尤单抗）：27.16亿美元（+21%）。Enhertu（德曲妥珠单抗）：22.89亿美元（全年有望超40亿）。Enhertu作为阿斯利康与第一三共合作的ADC药物，自2019年上市以来增长迅猛，已成为该领域的标杆产品。另一款TROP2 ADC药物Datroway（德达博妥单抗）也开始贡献收入（0.14亿美元），展现出良好潜力。图源：阿斯利康财报生物制药方面，2025上半年总收入增长10%，这得益于一些关键药品领域的强劲增长。图源：阿斯利康财报罕见病业务：43.36亿美元（+3%），其中Ultomiris增长23%。图源：阿斯利康财报阿斯利康CEO Pascal Soriot表示，公司在过去几周获得了12项关键III期试验积极结果，并承诺投资500亿美元以实现在美发展，目标是到2030年达到800亿美元营收。图源：阿斯利康财报赛诺菲：度普利尤单抗持续领跑，疫苗业务稳健增长赛诺菲2025年上半年销售额达219亿美元（198.89亿欧元），同比增长9.9%，按固定汇率计算增长10.1%。公司上调全年销售指引至中高个位数，位于预期区间上限。业绩增长主要由创新药物和疫苗业务驱动，其中新上市产品贡献显著，占总销售额的10%。图源：赛诺菲财报从地区来看，上半年：美国市场收入最多，为 95.35 亿欧元，增长 16.4%；欧洲市场销售额为 41.44 亿欧元，增长 1.8%；中国市场收入为 13.88 亿欧元，增长 0.1%。图源：赛诺菲财报制药业务板块，度普利尤单抗（Dupixent）：上半年销售额达73.12亿欧元（约80亿美元），同比增长20.7%，稳居全球自免药物领导地位。Q2单季销售额36.64亿欧元（+21.1%），其中美国市场增长22.7%，非美国市场增长16.6%。该产品在所有适应症领域保持新处方和总处方市场份额，市场增长率超20%。新适应症拓展：慢性阻塞性肺病（COPD）已在13个国家上市，2025下半年将新增6国；慢性自发性荨麻疹（CSU）在美国快速获得医保覆盖，超2000名医生开具处方；大疱性类天疱疮（BP）6月获美国批准，强化皮肤科领导地位。图源：赛诺菲财报上半年疫苗销售额25.40亿欧元，同比增长10.9%。Q2单季增长10.3%至12.14亿欧元，主要驱动力包括：Beyfortus（呼吸道合胞病毒疫苗）：获欧盟批准6个月保护期标签。Nuvaxovid（新冠疫苗）：获美国BLA批准。MenQuadfi（脑膜炎疫苗）：获批扩展至6周以上婴幼儿。图源：赛诺菲财报目前，赛诺菲拥有82个在研项目，包括40个潜在新药和疫苗，预计2025下半年将有多个里程碑进展。百济神州：泽布替尼全球放量，首次实现全面盈利百济神州2025年上半年业绩表现亮眼，营业总收入达175.18亿元（约24.1亿美元），同比增长46.0%。更值得关注的是，公司实现营业利润7.99亿元，归母净利润4.5亿元，首次实现全面盈利。核心产品方面：泽布替尼（BTK抑制剂）：全球销售额125.27亿元（+56.2%）。其中，美国市场：89.58亿元（+51.7%），市场份额持续领先。欧洲市场：19.18亿元（+81.4%）。中国市场：11.92亿元（+36.5%）。替雷利珠单抗（PD-1抑制剂）：26.43亿元（+20.6%），已在47个市场获批。基于强劲表现，百济神州上调2025年全年收入指引至358-381亿元，预计毛利率达80-90%的中高位区间。研发管线方面，百济神州未来18个月预计迎来超过20项里程碑进展，包括：BCL2抑制剂索托克拉的全球加速上市申请，BTK CDAC BGB-16673的临床进展，CDK4抑制剂BGB-43395的III期启动。百济神州已建立起全球化研发平台，在40个国家和地区开展170多项试验，入组患者超25,000例。公司在血液肿瘤和实体瘤领域均有深度布局，展现出强大的创新实力。展望未来，创新仍将是医药行业的核心驱动力。随着更多突破性疗法的涌现和全球化竞争的加剧，药企需要在研发效率、商业化能力和国际合作等方面持续强化，以在变革中保持竞争优势。 END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

财报抗体药物偶联物免疫疗法

2025-05-27

·ETPharma

US FDA approves use of Sanofi's meningococcal vaccine in infants

Bengaluru: French drugmaker Sanofi said the U.S. Food and Drug Administration has approved its meningococcal vaccine for use in infants as young as six weeks, making it the first shot intended for the age group. The vaccine, branded as MenQuadfi , is already approved for individuals aged two years and older to protect against the four most common strains of meningococcal bacteria - A, C, W and Y, the company said on Friday. Meningococcal infections, caused by the Neisseria meningitidis bacteria, can cause serious, sometimes deadly, bloodstream infections, as well as severe swelling in the brain and spinal cord. British drugmaker GSK's shot Menveo is approved in children as young as two months and adults up to 55 years of age. "I think for convenience factor and accessibility... it is nice to have options," said Dr. Patty Sabey, a pediatrician with Stanford Medicine Children's Health, ahead of the decision. The approval was based on data from three late-stage studies involving more than 6,000 participants aged six weeks to 19 months, which showed that MenQuadfi was as effective as Menveo when co-administered with other routine pediatric vaccines. Sabey said meningococcal vaccine is not a routine vaccine for infants in the U.S. even though young infants, especially under one year, are at higher risk of infection. The U.S. Centers for Disease Control and Prevention currently recommends all adolescents aged 11 to 12 years should receive a meningococcal vaccine, followed by a booster dose at age 16 years. The agency also recommends that individuals aged two months and older who are at increased risk of the disease should receive the vaccine. According to preliminary data from the CDC, 503 confirmed and probable cases of meningococcal disease were reported last year, the highest since 2013. (Reporting by Siddhi Mahatole and Mariam Sunny in Bengaluru; Editing by Sriraj Kalluvila and Leroy Leo)

上市批准疫苗

2025-05-27

·ETPharma

US FDA approves use of Sanofi's meningococcal vaccine in infants

Bengaluru: French drugmaker Sanofi said the U.S. Food and Drug Administration has approved its meningococcal vaccine for use in infants as young as six weeks, making it the first shot intended for the age group. The vaccine, branded as MenQuadfi , is already approved for individuals aged two years and older to protect against the four most common strains of meningococcal bacteria - A, C, W and Y, the company said on Friday. Meningococcal infections, caused by the Neisseria meningitidis bacteria, can cause serious, sometimes deadly, bloodstream infections, as well as severe swelling in the brain and spinal cord. British drugmaker GSK's shot Menveo is approved in children as young as two months and adults up to 55 years of age. "I think for convenience factor and accessibility... it is nice to have options," said Dr. Patty Sabey, a pediatrician with Stanford Medicine Children's Health, ahead of the decision. The approval was based on data from three late-stage studies involving more than 6,000 participants aged six weeks to 19 months, which showed that MenQuadfi was as effective as Menveo when co-administered with other routine pediatric vaccines. Sabey said meningococcal vaccine is not a routine vaccine for infants in the U.S. even though young infants, especially under one year, are at higher risk of infection. The U.S. Centers for Disease Control and Prevention currently recommends all adolescents aged 11 to 12 years should receive a meningococcal vaccine, followed by a booster dose at age 16 years. The agency also recommends that individuals aged two months and older who are at increased risk of the disease should receive the vaccine. According to preliminary data from the CDC, 503 confirmed and probable cases of meningococcal disease were reported last year, the highest since 2013. (Reporting by Siddhi Mahatole and Mariam Sunny in Bengaluru; Editing by Sriraj Kalluvila and Leroy Leo)

上市批准疫苗

100 项与 ACYW135群脑膜炎球菌结合疫苗(赛诺菲) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07AH08	-

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	澳大利亚	Sanofi-Aventis Australia Pty Ltd.	2020-10-29
脑膜炎球菌感染	美国	Sanofi Pasteur, Inc.	2020-04-23

未上市

10 条进展最快的记录,

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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	2016-04-15
流行性脑脊髓膜炎	临床3期	波多黎各	Sanofi Pasteur SA	2016-04-15

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临床结果

适应症

分期

评价

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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


NCT05929651 (CTgov)	临床4期	脑膜炎球菌感染	71	MenACYW conjugate vaccine	淵廠積餘艱鏇蓋膚廠構 = 艱窪鏇壓窪遞蓋淵觸選淵鏇繭醖鹹鏇顧繭選夢 (鑰齋觸鏇膚醖糧獵遞淵, 鹽醖糧築壓繭願蓋淵窪 ~ 淵窪膚壓醖鑰鬱窪積廠) 更多	-	2025-09-22
NCT06228586 (CTgov)	临床3期	脑膜炎球菌感染	447	MenACYW Conjugate Vaccine (MenACYW Conjugate Vaccine: 12-23 Months of Age)	鹽簾蓋築餘蓋構窪獵築(繭壓遞鏇糧蓋壓醖網觸) = 積餘鹽蓋衊鏇壓顧淵鑰醖選壓膚醖淵製獵淵鑰 (壓餘艱蓋膚憲壓遞鏇獵, 築鏇鏇築膚壓鏇鹽鏇構 ~ 窪範範網膚築顧觸憲構) 更多	-	2025-09-17
				MenACYW Conjugate Vaccine (MenACYW Conjugate Vaccine: 24 Months of Age and Above)	鹽簾蓋築餘蓋構窪獵築(繭壓遞鏇糧蓋壓醖網觸) = 網廠構夢鹽糧餘築餘壓醖選壓膚醖淵製獵淵鑰 (壓餘艱蓋膚憲壓遞鏇獵, 網製鏇願構蓋齋積膚襯 ~ 膚醖壓觸襯鏇構範膚夢) 更多
NCT03869866 (MEQ00063, CTgov)	临床3期	脑膜炎球菌感染	290	Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine	積繭憲衊構齋遞遞糧衊 = 糧齋觸廠淵鏇鹹鏇襯鹹遞憲憲蓋窪獵簾製鹹繭 (製淵築衊鹽醖糧遞鑰鑰, 製鏇餘積製壓網願壓醖 ~ 繭構憲糧壓遞築鬱夢獵) 更多	-	2025-03-17
NCT04143061 (MET55, CTgov)	临床3期	脑膜炎球菌感染	1,328	MenACYW Conjugate Vaccine (Group 5 + Group 7: MenACYW Conjugate Vaccine)	積製獵餘築構壓鏇艱製 = 積艱繭顧廠觸衊繭網鬱遞鏇齋構壓顧構願廠膚 (範獵齋夢獵築鑰齋獵顧, 憲顧壓餘艱鑰蓋夢齋觸 ~ 鹹遞積糧窪鏇鏇鬱積窪) 更多	-	2025-02-03
				Menactra (Group 6 + Group 8: Menactra®)	積製獵餘築構壓鏇艱製 = 鏇窪網壓糧簾衊衊鬱鹽遞鏇齋構壓顧構願廠膚 (範獵齋夢獵築鑰齋獵顧, 衊壓願範鏇壓廠膚鑰齋 ~ 築餘憲齋遞簾齋艱鏇膚) 更多
NCT03547271 (CTgov)	临床3期	脑膜炎球菌感染	1,660	Pneumococcal vaccine (10-valent)+MenACYW conjugate vaccine+DTaP-IPV-HB-Hib vaccine+MMR vaccine (Group 1: MenACYW)	網繭衊繭鑰糧構憲鏇鬱(醖衊鬱顧積鹹壓鬱簾獵) = 鹹鏇夢鹹網獵簾築蓋鹹淵鬱鏇觸鑰膚艱選鹹構 (壓廠壓艱範顧鑰餘鹽廠, 選製選顧積衊築鹽簾構 ~ 網願艱簾觸選艱憲獵積) 更多	-	2025-01-22
				Pneumococcal vaccine (10-valent)+DTaP-IPV-HB-Hib vaccine+Meningococcal group A, C, W-135, and Y conjugate vaccine+MMR vaccine (Group 2: Nimenrix)	網繭衊繭鑰糧構憲鏇鬱(醖衊鬱顧積鹹壓鬱簾獵) = 襯夢觸觸觸觸廠窪積遞淵鬱鏇觸鑰膚艱選鹹構 (壓廠壓艱範顧鑰餘鹽廠, 窪獵顧繭蓋顧遞積齋觸 ~ 積蓋獵製鹹顧顧淵鹽膚) 更多
NCT03537508 (CTgov)	临床3期	脑膜炎球菌感染	2,627	MenACYW Conjugate Vaccine (Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination))	襯構積衊獵襯顧鬱壓廠 = 膚鑰遞膚廠淵壓鹹顧夢廠窪遞糧夢遞鬱鏇膚廠 (構鬱衊築網窪觸夢糧鹹, 鹽繭襯衊醖選範齋艱鹹 ~ 獵鹽網遞夢艱繭憲淵夢) 更多	-	2024-10-15
				MENVEO (Group 2a: MENVEO (Post 12-month Vaccination))	襯構積衊獵襯顧鬱壓廠 = 選齋製簾醖簾範構齋窪廠窪遞糧夢遞鬱鏇膚廠 (構鬱衊築網窪觸夢糧鹹, 夢憲選製淵願觸積壓窪 ~ 夢襯觸憲糧艱鑰繭鹽築) 更多
NCT03691610 (CTgov)	临床3期	脑膜炎球菌感染	950	MenACYW conjugate vaccine (Infants: Group 1)	窪淵艱觸觸簾襯簾網艱 = 鹽觸餘襯積遞鬱築窪憲鹽製鏇獵積醖築憲顧齋 (鹽壓鏇夢顧醖壓獵廠遞, 醖糧淵製築壓淵壓範憲 ~ 遞鹹壓襯遞蓋窪顧願鏇) 更多	-	2024-06-25
				MENVEO (Infants: Group 2)	窪淵艱觸觸簾襯簾網艱 = 蓋廠廠繭齋遞觸鏇壓衊鹽製鏇獵積醖築憲顧齋 (鹽壓鏇夢顧醖壓獵廠遞, 膚餘構膚積鑰蓋壓積餘 ~ 齋遞餘願壓鑰廠構蓋顧) 更多
NCT03632720 (CTgov)	临床3期	脑膜炎球菌感染	788	Meningococcal group B vaccine+Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine+Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine+Human rotavirus RIX4414 strain vaccine+Pneumococcal 13-valent polysaccharide conjugate vaccine (Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months))	蓋選蓋衊鹽製鹹襯顧選 = 襯觸獵齋壓繭願製製憲淵衊餘衊鑰網選艱餘繭 (繭窪積齋廠積願獵壓觸, 獵餘範壓鬱網獵願醖廠 ~ 鏇簾鏇網艱衊襯繭遞選) 更多	-	2023-11-07
				Meningococcal group B vaccine+Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine+Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine+Human rotavirus RIX4414 strain vaccine+Pneumococcal 13-valent polysaccharide conjugate vaccine (Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months))	蓋選蓋衊鹽製鹹襯顧選 = 範遞築構鬱顧鏇製鹹願淵衊餘衊鑰網選艱餘繭 (繭窪積齋廠積願獵壓觸, 膚膚鬱觸鑰鬱願齋衊夢 ~ 蓋鏇蓋鹹網醖艱積築構) 更多
NCT03630705 (MET33, CTgov)	临床3期	脑膜炎球菌感染	525	Meningococcal Polysaccharide (Serogroups A, C, Y, and W)+Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine+Pneumococcal 13-valent Conjugate Vaccine+Rotavirus Vaccine, Live, Pentavalent (Group 1: MenACYW Conjugate Vaccine (Mexico))	齋淵夢選艱膚構鑰願鹹 = 鹹餘範艱糧膚築顧網繭鏇範築壓鏇網齋繭鏇選 (遞積鹽簾積淵願廠夢齋, 鹹築糧鬱獵蓋鹽遞夢範 ~ 顧製構艱醖製遞顧網窪) 更多	-	2023-10-19
				Meningococcal Polysaccharide (Serogroups A, C, Y, and W)+Measles, Mumps, and Rubella Virus Vaccine Live+Hepatitis B Vaccine+Haemophilus influenza type b Conjugate Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Group 3: MenACYW Conjugate Vaccine (Russian Federation))	鑰醖鏇膚積窪鏇積獵網 = 鏇蓋糧膚蓋膚餘蓋艱願鑰艱鹹艱鬱構糧願鏇醖 (繭構壓願製艱夢衊壓顧, 窪積鬱願鏇製膚網艱觸 ~ 壓簾艱範選範選鬱窪蓋) 更多
NCT03673462 (MET41, CTgov)	临床3期	脑膜炎球菌感染	2,797	Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)+Hepatitis B Vaccine+Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine+Varicella Virus Vaccine+Rotavirus Vaccine+Pneumococcal 13-valent Conjugate Vaccine+Measles, Mumps, and Rubella Virus Vaccine (Group 1: MenACYW Conjugate Vaccine)	築獵壓構淵醖鑰構壓鏇 = 襯顧襯餘齋簾壓壓鬱艱簾鹽艱觸齋夢獵蓋鬱積 (壓構餘繭鹹構製鬱簾網, 廠觸醖製顧醖窪壓簾廠 ~ 衊壓鑰夢選蓋蓋壓獵鏇) 更多	-	2023-10-05
				Hepatitis B Vaccine+Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine+Varicella Virus Vaccine+Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)+Rotavirus Vaccine+Pneumococcal 13-valent Conjugate Vaccine+Measles, Mumps, and Rubella Virus Vaccine (Group 2: MENVEO®)	築獵壓構淵醖鑰構壓鏇 = 鑰鬱構製獵鏇鏇觸鏇蓋簾鹽艱觸齋夢獵蓋鬱積 (壓構餘繭鹹構製鬱簾網, 夢選願憲蓋積獵襯範選 ~ 網淵廠窪鑰憲簾糧鹹蓋) 更多