21价肺炎球菌结合疫苗(默沙东)(Pneumococcal 21-valent Conjugate Vaccine) - 在研适应症：侵袭性肺炎球菌病，肺炎球菌性肺炎，流感病毒感染_专利_临床

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

Pneumococcal 21-valent Conjugate Vaccine、Polyvalent pneumococcal conjugate vaccine Merck Sharp Dohme Corp、Ppcv

+ [4]

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病

在研适应症

侵袭性肺炎球菌病肺炎球菌性肺炎流感病毒感染+ [1]

非在研适应症-

原研机构

Merck & Co., Inc.

在研机构

Merck Sharp & Dohme Corp.Merck Sharp & Dohme LLCMerck Sharp & Dohme (Australia) Pty Ltd.

+ [1]

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (2024-06-17),

侵袭性肺炎球菌病肺炎球菌性肺炎

最高研发阶段(中国)-

特殊审评优先审评 (美国)、突破性疗法 (美国)

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关联

14

项与 21价肺炎球菌结合疫苗(默沙东) 相关的临床试验

NCT06829238

/ Recruiting临床4期IIT

Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals with a History of Injection Drug Use (MET-IH)

This randomized clinical trial (RCT) evaluates whether metformin can reduce systemic inflammation and improve immune function in individuals with a history of injection drug use, with or without HIV. Participants will receive metformin or placebo and undergo immune system assessments, including vaccine response evaluations.

开始日期2025-03-07

申办/合作机构

The University of Alabama at Birmingham

[+1]

CTIS2023-506236-32-00

/ Not yet recruiting临床3期

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease. - V116-013

开始日期2024-04-02

申办/合作机构

Merck Sharp & Dohme Corp.

NCT06177912

/ Completed临床3期

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting invasive pneumococcal disease (IPD).

开始日期2024-01-18

申办/合作机构

Merck Sharp & Dohme LLC

100 项与 21价肺炎球菌结合疫苗(默沙东) 相关的临床结果

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100 项与 21价肺炎球菌结合疫苗(默沙东) 相关的转化医学

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100 项与 21价肺炎球菌结合疫苗(默沙东) 相关的专利（医药）

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19

项与 21价肺炎球菌结合疫苗(默沙东) 相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Health and economic impact of the 21-valent pneumococcal conjugate vaccine (V116) for adults in Japan: a delta price approach

Article

作者: Cassell, Kelsie ; Owusu-Edusei, Kwame ; Mueller, Peter P. ; Tajima, Atsushi ; Johnson, Kelly D. ; Yi, Zinan ; Cossrow, Nicole ; Matsuki, Taizo

INTRODUCTION:

This study analyzed the health and economic impact of the 21-valent pneumococcal conjugate vaccine (V116) and the 20-valent pneumococcal conjugate vaccine (PCV20), as well as their relative cost-effectiveness, in Japanese adults aged 65 years using a delta pricing approach.

METHODS:

A Markov model was employed to simulate the movement of the Japanese population among four health states: healthy, pneumococcal disease (consisting of invasive pneumococcal disease [IPD] with or without meningitis and non-bacteremic pneumococcal pneumonia [NBPP]), post-meningitis sequelae, and death. The model was populated with publicly available demographic and epidemiologic data, stratified by risk level. Pneumococcal serotype distribution and vaccine effectiveness, as well as direct and indirect treatment costs and health-related utilities, were derived from published sources. The model used a lifetime horizon and 2% discounting of costs and life-years. Costs were adjusted to 2023 values in Japanese yen (¥). Outcomes were cases and deaths, life-years and quality-adjusted life-years (QALYs), vaccination and treatment costs, and incremental cost-effectiveness ratios. The range over which V116 was cost-saving and cost-effective was determined.

RESULTS:

Compared to PCV20, V116 averted an additional 28 cases of IPD, 918 cases of NBPP, 5 deaths from IPD, and 51 deaths from NBPP over the lifetime of a single age 65 cohort. Life-years and QALYs gained were 1,019 and 642, respectively, relative to PCV20; V116 saved ¥733 million in direct medical costs and ¥557 million in indirect costs, compared to PCV20. V116 was found to be cost-saving at price premiums up to ¥1,322 (payer perspective) or ¥2,327 (societal perspective) and remained below a willingness-to-pay threshold of ¥5 million/QALY for premiums up to ¥7,113 (payer perspective) or ¥8,117 (societal perspective).

CONCLUSIONS:

V116 is projected to provide more population health benefits in Japan than PCV20, and to be cost-effective at a variety of price premiums.

2025-01-28·mSphere

Establishing a new human pneumococcal standard reference serum, MPRSS-01

Article

作者: Green, Tina ; Abeygunawardana, Chitrananda ; Schmauch, Jenna ; Greway, Rebecca ; Malinverni, Juliana C. ; Murphy, Rocio D. ; Bonhomme, Cyrille J. ; Howlett, Adrienne ; Antonello, Joseph M. ; Gowrisankar, Rajam ; Nolan, Katrina M.

ABSTRACT:

Measuring the immunogenicity of pneumococcal vaccines involves the use of immunoassays to measure serotype-specific immunoglobulin G (IgG) antibody levels post-vaccination with the current Streptococcus pneumoniae human reference serum standard (007sp) for anti-pneumococcal capsule antibodies. Development of new pneumococcal conjugate vaccines (PCVs) with additional serotypes not in 007sp (e.g., V116, a 21-valent PCV) requires a new reference serum. Antibody concentrations to 33 pneumococcal serotypes were assigned in a new Merck Pneumococcal Reference Serum Standard (MPRSS-01; Merck Pneumococcal Reference Serum Standard) using the pneumococcal electrochemiluminescence assay. MPRSS-01 was generated by pooling high-titer serum samples from adults immunized with either 23-valent pneumococcal polysaccharide vaccine (PPSV23) or V116. For the 24 serotypes with established IgG concentrations, the corresponding antibody concentrations in MPRSS-01 were assigned via direct calibration to 007sp, while a cross-standardization approach was used for the nine novel serotypes. Serotype 7F was initially chosen as the reference calibrator for cross-standardization due to parallelism across dilution–response curves demonstrated across all 33 serotypes, and an evaluation of the single-calibrator approach was conducted for the 24 serotypes. Potential systematic bias from using a unique serotype for calibration was identified and addressed by further adjusting the estimated IgG concentrations of the nine novel serotypes. Using the final MPRSS-01 antibody concentration assignments, and the calibration factor relating MPRSS-01 to 007sp, antibody concentration assignments for 007sp were provided for the nine novel serotypes. This proposal was accepted by the Center for Biologics Evaluation and Research (CBER), enabling V116 to bridge old and new human pneumococcal reference sera.

IMPORTANCE:

Immunogenicity of pneumococcal vaccines is measured using post-vaccination serotype-specific immunoglobulin G (IgG) antibodies in serum using enzyme-linked immunoassays with the 007sp reference serum containing serotype-specific IgG for 24 pneumococcal serotypes. With the development of next-generation PCVs, a new S. pneumoniae reference serum standard was needed to include serotypes beyond the existing 24 in 007sp. In this study, antibody concentrations to 33 pneumococcal serotypes were assigned in a new Merck Pneumococcal Reference Serum Standard (MPRSS-01) using the pneumococcal electrochemiluminescence assay, enabling V116 to maintain the link to the historical human pneumococcal standard reference serum while utilizing the new human pneumococcal reference serum.

2024-12-17·CLINICAL INFECTIOUS DISEASES

A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine–Experienced Adults 50 Years of Age or Older (STRIDE-6)

Article

作者: Porterfield, Laura ; Chapman, Timothy J ; Jaffuel, Sylvain ; Greenberg, David ; Johnston, William Henry ; Pelayo, Enrique ; Orenstein, Walter A ; Haranaka, Miwa ; Tellier, Guy ; Rosen, Jeffrey Bruce ; Vilella i Morato, Anna ; Grijalva, Carlos G ; Lee, Jacob ; Lee, Dong-Gun ; Dionne, Marc ; Scott, Paul ; Castagna, Antonella ; Stacey, Helen L ; Lenzmeier, Thomas C ; Davis, Karyn ; Girard, Ginette ; Freeman, George Hartley ; Butuk, David J ; Yono, Makoto ; Peer, Avivit ; Darawsha, Mahmud ; Caraco, Yoseph ; Echave-Sustaeta Maria-Tome, Jose Maria ; Chowers, Michal ; Cardona, Jose Francisco ; Song, Joon Young ; Fiel, Thomas ; Nicolas, Jean-Francois ; Choi, Jung Hyun ; Dzongowski, Peter ; Choi, Won Suk ; Li, Jianing ; Huang, Kuo-Chin ; Shi, Hyejin ; Tytus, Richard ; Harper, Charles Harold ; Stacey, Helen ; Aumatell, Cristina Masuet ; Costantino, Claudio ; Ami, Eytan Ben ; Rigonan, Kathryn R ; Martinelli, Domenico ; Gallagher, Nancy ; Platt, Heather L ; Fraser, Neil J ; Perez, Silvia Narejos ; Yang, Yi-Ching ; Bendayan, Daniele ; Zeng, Tiantian ; Fernsler, Doreen ; De luiz Martinez, Gustavo ; Geller, Steven A ; Daboul, Nizar ; Blasi, Francesco Bruno

Abstract:

Background:

Pneumococcal diseases cause considerable morbidity and mortality in adults. V116 is an investigational 21-valent pneumococcal conjugate vaccine (PCV) specifically designed to protect adults from pneumococcal serotypes responsible for the majority of residual pneumococcal diseases. This phase 3 study evaluated safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine–experienced adults aged ≥50 years.

Methods:

A total of 717 adults were enrolled to receive a single dose of pneumococcal vaccine as follows: cohort 1 (n = 350) previously received 23-valent pneumococcal polysaccharide vaccine (PPSV23) and were randomized 2:1 to receive V116 or PCV15, respectively; cohort 2 (n = 261) previously received PCV13 and were randomized 2:1 to receive V116 or PPSV23, respectively; cohort 3 (n = 106) previously received PPSV23 + PCV13, PCV13 + PPSV23, PCV15 + PPSV23, or PCV15 and all received open-label V116. Immunogenicity was evaluated 30 days postvaccination using opsonophagocytic activity (OPA) geometric mean titers (GMTs) and immunoglobulin G (IgG) geometric mean concentrations (GMCs) for all V116 serotypes. Safety was evaluated as the proportion of participants with adverse events (AEs).

Results:

V116 was immunogenic across all 3 cohorts as assessed by serotype-specific OPA GMTs and IgG GMCs postvaccination for all 21 serotypes. V116 elicited comparable immune responses to serotypes shared with PCV15 (cohort 1) or PPSV23 (cohort 2), and higher immune responses to serotypes unique to V116. The proportions of participants with solicited AEs were generally comparable across cohorts.

Conclusions:

V116 is well tolerated with a safety profile comparable to currently licensed pneumococcal vaccines and generates IgG and functional immune responses to all V116 serotypes, regardless of prior pneumococcal vaccine received.

Clinical Trials Registration:

NCT05420961; EudraCT 2021-006679-41.

139

项与 21价肺炎球菌结合疫苗(默沙东) 相关的新闻（医药）

2025-03-12

·健识局

默沙东、礼来斥巨资在美国建厂，将影响全球CDMO行业

根据外媒消息，3月11日，默沙东宣布将在北卡罗来纳州开设一家生产四价HPV疫苗的工厂。默沙东计划在原有工厂的基础上进行扩建，预计追加投资10亿美元。默沙东方面对外表示：该工厂始建于2004年，目前已拥有1000多名员工，去年生产7000多万剂疫苗，包括预防水痘、麻疹、风疹等多种疫苗产品。公司预计今年的疫苗产量还会增加。就在几天前，礼来也宣布：今年在美国新建4座工厂，重点生产其畅销减肥、糖尿病药物的活性成分。这一投资总额将超500亿美元，刷新美国制药业历史纪录；辉瑞则在3月初则表示，公司可能将部分海外生产季度转移至美国现有工厂。美国新任总统特朗普上台之后，曾持续向药企施压，要求将药品生产迁回美国，并威胁对进口药品加征关税。跨国药企不得不重返美国搭建工厂。这些医药制造产能回流美国可能会对中国CDMO行业产生深远的影响。默沙东疫苗生产已经收回在宣布在美国追加投资建厂之前，默沙东已发起对药明生物子公司（药明海德）爱尔兰疫苗工厂的收购。交易预计将在2025上半年完成交割。药明海德原本与默沙东签有长达20年的疫苗供应合同，总价值是30亿美元。但在2025年1月，药明生物突然宣布将出售爱尔兰疫苗工程，默沙东以5亿美元的金额收购。药明生物在第43届JP摩根医疗健康大会上透露：爱尔兰生物药的生产基地未达到盈亏平衡的预期。但从目前默沙东加大美国本土产能投入的表现来看，恐怕是因为爱尔兰工厂当时隶属于中国企业药明生物。 2024年6月，默沙东21价肺炎球菌结合疫苗（Capvaxive）在美国获批上市，当年获得5000万美元的销售收入。而另一款保护婴儿免受呼吸道合胞病毒感染的疫苗预计于2025年6月获批上市。这两款疫苗产品都被默沙东寄予厚望。不过进入2025年后，在一系列贸易壁垒面前，默沙东不得不把产能控制在自己手里。跨国药企的生产回流到美国，所有研发、生产、制造的成本都会上升，药企不得不从别的渠道控制成本，减少不必要的开支。这一系列的举动无疑将影响着全球CDMO产业的布局。业内人士指出，如果跨国药企的业务减少外包，都选择自己做，那无疑将CDMO产业推向寒冬。不仅仅是对中国企业，对全球CRO行业都会有影响。产业脱钩，一场双输的赌局目前全球CDMO行业中，龙沙集团、康泰伦特和三星生物占据前三位，市场份额约为30%。而中国CDMO企业发展时间较短，主要依靠欧美药企的订单支撑。药明生物就曾公开表示，2024年新签项目中有超过一半来自美国。特朗普出任美国新任总统之后，曾多次要求制造业将生产环节迁回美国，并威胁对进口药品加征关税。2月21日，他在一次私下会议上警告制药公司“必须加快行动”，否则将面临关税冲击。表面上看，跨国药企重回美国建厂是各家自主选择的行为，美国国家并没有立法规定这样做；但实际上，美国挥动贸易保护大棒，企业自然要提前规避可能的风险。市场最担心的是全球药品生产供应链脱钩，一方面让CDMO产业丧失巨额订单，同时让跨国药企的产能调整可能高达数十亿美元，是一场双输的赌局。实际上，美国医药高度依赖于全球外包供应链。据美国本土报告，2021年美国52%的制剂生产设施、73%的原料药生产设施都在本土之外，其中中国占比制剂的6%、原料药的13%。而中国的CDMO企业在全球创新药产业链中发挥了重要作用。根据申万宏源的数据显示，2020年至2023年，国内CDMO企业的年复合增长率都在30%以上，远高于全球平均水平。跨国药企离不开中国生物制药供应链，中国的CDMO企业也离不开美国客户，这个情况短期内不会改变，即便是美国总统有意见也不行。撰稿丨小米编辑丨江芸贾亭运营｜廿十三插图｜视觉中国声明：健识局原创内容，未经许可请勿转载头对头击败“肺癌神药”？阿斯利康回应挂网价虚高“暴利链”现形！湖南公示药品产销成本新事 | 双成药业将出现退市风险

疫苗并购财报信使RNA

2025-02-06

·药时空

默沙东2024年财报：K药大卖近300亿美元，中国区营收下滑20%（附PPT）

2月4日，默沙东公布2024年财报。默沙东董事长兼首席执行官Rob Davis表示：“2024年，我们实现了强劲增长，这主要得益于市场对我们创新产品组合的强劲需求，包括明星药物KEYTRUDA的持续畅销、WINREVAIR的成功推出，以及动物保健业务的出色表现。未来，我们将继续推进产品线，加速关键临床项目，并通过有前景的业务发展机会来进一步扩充产品组合。得益于我们全球团队的卓越努力和奉献精神，我们的业务目前处于有利地位，我对公司的长期增长潜力充满信心，比以往任何时候都要坚定。” 一、整体业绩情况 2024年，默沙东总营收641.68亿美元，同比增长7%。制药业务收入574.00亿美元，同比增长7%，但研发投入为179.38亿美元，同比下降41%。值得注意的是，中国区收入同比下滑20%至53.94亿美元，占默沙东全球制药业务9.4%的份额。二、明星产品表现药王Keytruda（帕博利珠单抗）：2024年创造新销售记录，以18%的增长速度创收294.82亿美元，销售额约占全年总营收的46%。默沙东还在努力将其临床和商业化价值最大化，如拓展早期适应症、联用布局、开发皮下制剂等。2024年11月，K药皮下制剂的III期研究成功，给药时间大幅缩短至2 - 3分钟。其他肿瘤产品：全球首创HIF - 2α抑制剂Welireg销售额达5.09亿美元，同比增长133%，2024年11月在华获批上市。Lynparza（奥拉帕利）为默沙东带来13.11亿美元的收入分成。 HPV疫苗Gardasil/Gardasil 9：全年销售额85.83亿美元，同比下降3%。2024Q3财报中初显颓势，主要因中国地区需求减少，竞争激烈。不过默沙东有应对策略，率先开拓男性市场，2025年1月，Gardasil在华获批适用于9 - 26岁男性接种的新适应证，Gardasil 9也已申报男性适应症，同时还在开发多价HPV疫苗。其他疫苗产品：2024年6月，21价肺炎球菌结合疫苗Capvaxive获批上市，与Pneumovax 23和Vaxneuvance（15价）形成更全面的肺炎球菌疫苗产品布局。后两者全年销售额分别为2.63亿美元（-36%）和8.08亿美元（+22%）。三、新兴产品亮点心血管领域：肺动脉高压（PAH）新药Winrevair是第一个被批准用于治疗PAH的激活素信号抑制剂疗法，仅需每3周皮下注射一次。自2024年3月在美国获批上市以来，不到一年时间销售额达4.19亿美元，在中国也已申报上市。抗感染领域：Clesrovimab已在美申报上市，有望成为首个为婴儿提供6个月保护的单剂量RSV单抗。眼科领域：眼科三抗MK - 3000已进入II/III期研究阶段，是默沙东2024年5月以30亿美元收购EyeBio公司获得的。四、未来展望展望2025年，默沙东预计全球销售额将在641亿美元至656亿美元之间。默沙东在今年的JPM大会上描绘未来蓝图，20款潜在“重磅炸弹”药物将陆续浮现，多款ADC是重头戏，覆盖多个潜力靶点。本报告共有35页，点击文末【阅读原文】可进行下载。本报告共有35页，点击文末【阅读原文】可进行下载。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

财报疫苗并购上市批准临床3期

2025-02-05

·echemi

Merck Reports 2024 Revenue of $64.168 Billion Driven by Keytruda and Innovative Products

On February 4, Merck & Co. announced its 2024 financial results, revealing total revenue of $64.168 billion, marking a 7% increase year-on-year. The pharmaceutical segment alone generated $57.400 billion, also reflecting a 7% growth. However, research and development (R&D) spending dropped significantly to $17.938 billion, a decline of 41%. In a concerning trend, revenue from the Chinese market fell by 20% to $5.394 billion, representing 9.4% of Merck's global pharmaceutical sales. Despite these challenges, Merck's flagship product, Keytruda (pembrolizumab), set new sales records, achieving $29.482 billion in revenue, an 18% increase that accounted for nearly 46% of the company’s total revenue. As Keytruda continues to thrive, Merck is actively working to maximize its clinical and commercial value. This includes expanding early indications, exploring combination therapies, and developing a subcutaneous formulation. In November 2024, the subcutaneous formulation's Phase III study was successfully completed, reducing administration time to just 2-3 minutes compared to intravenous infusion. Other oncology products also performed well, with the world’s first HIF-2α inhibitor, Welireg, generating $509 million in sales, up 133% year-on-year. This drug received approval in China in November 2024. Additionally, Lynparza (olaparib) contributed $1.311 billion to the revenue. Merck's HPV vaccine, Gardasil/Gardasil 9, reported sales of $8.583 billion, a 3% decrease from the previous year. The decline was largely attributed to reduced demand in China, exacerbated by intense competition from domestic nine-valent vaccines and price wars involving two-valent HPV vaccines. In response, Merck has begun targeting the male market for HPV vaccination. In January 2025, Gardasil was approved in China for use in males aged 9-26, marking it as the first HPV vaccine approved for this demographic. Merck has also been proactive in updating its vaccine portfolio. In June 2024, it launched the 21-valent pneumococcal conjugate vaccine, Capvaxive, enhancing its product lineup alongside Pneumovax 23 and Vaxneuvance. In the cardiovascular sector, the new pulmonary arterial hypertension (PAH) drug Winrevair has emerged as a star product. Approved in March 2024, it has quickly generated $419 million in sales within its first year. The drug has also been submitted for approval in China. Looking ahead, Merck is optimistic about its pipeline, which includes oral PCSK9 inhibitors and dual agonists for GLP-1R/GCGR expected to yield critical research data in 2025. The company is also ramping up efforts in infectious diseases and ophthalmology, with Clesrovimab submitted for U.S. approval as a single-dose RSV monoclonal antibody. Merck's business development activities have intensified, particularly in China, with several strategic acquisitions aimed at expanding its innovative capabilities. These include a $700 million acquisition of CD3/CD19 bispecific antibodies and a $588 million agreement for a PD-1/VEGF bispecific antibody project. Robert M. Davis, Merck’s Chairman and CEO, expressed confidence in the company’s long-term growth potential, stating, “Our strong growth in 2024 reflects the market demand for our innovative product portfolio, including Keytruda, Winrevair, and our robust animal health business.” Looking forward to 2025, Merck anticipates global sales between $64 billion and $65.6 billion.

上市批准并购临床3期疫苗财报

100 项与 21价肺炎球菌结合疫苗(默沙东) 相关的药物交易

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研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
侵袭性肺炎球菌病	美国	Merck Sharp & Dohme LLC	2024-06-17
肺炎球菌性肺炎	美国	Merck Sharp & Dohme LLC	2024-06-17

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
流感病毒感染	临床3期	美国	Merck Sharp & Dohme Corp.	2022-09-23
肺炎球菌感染	临床3期	美国	Merck Sharp & Dohme Corp.	2022-07-13
肺炎球菌感染	临床3期	澳大利亚	Merck Sharp & Dohme Corp.	2022-07-13
肺炎球菌感染	临床3期	比利时	Merck Sharp & Dohme Corp.	2022-07-13
肺炎球菌感染	临床3期	智利	Merck Sharp & Dohme Corp.	2022-07-13
肺炎球菌感染	临床3期	德国	Merck Sharp & Dohme Corp.	2022-07-13
肺炎球菌感染	临床3期	新西兰	Merck Sharp & Dohme Corp.	2022-07-13
肺炎球菌感染	临床3期	波多黎各	Merck Sharp & Dohme Corp.	2022-07-13
肺炎球菌感染	临床3期	南非	Merck Sharp & Dohme Corp.	2022-07-13
肺炎球菌感染	临床3期	瑞典	Merck Sharp & Dohme Corp.	2022-07-13

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临床结果

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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


NCT05696080 (V116-008 \| STRIDE-8, CTgov)	临床3期	肺炎球菌感染	518	Placebo+V116 (V116 + Placebo)	糧鏇醖鑰餘壓齋鏇顧艱 = 獵顧鑰鏇獵淵夢網範襯範餘網鹽鹽齋淵鑰淵觸 (齋獵網鬱淵積襯積夢網, 艱艱壓憲襯衊繭遞積膚 ~ 廠繭醖壓衊顧網顧壓窪) 更多	-	2025-02-26
				PPSV23+PCV15 (PCV15 + PPSV23)	糧鏇醖鑰餘壓齋鏇顧艱 = 醖築鏇襯糧獵顧蓋鏇廠範餘網鹽鹽齋淵鑰淵觸 (齋獵網鬱淵積襯積夢網, 鑰夢廠艱憲積衊選襯憲 ~ 壓選憲蓋廠繭鏇顧築壓) 更多
NCT05569954 (V116-010 \| STRIDE-10, CTgov)	临床3期	肺炎球菌感染	1,484	V116 (V116)	築醖艱夢構鬱繭窪鑰齋 = 糧簾襯壓簾艱觸觸網鏇膚構鑰衊鬱鬱醖願襯壓 (網窪餘憲獵繭廠鏇選選, 憲襯壓蓋範遞衊鹹廠憲 ~ 醖憲醖齋餘鹽顧簾築壓) 更多	-	2024-10-31
				PPSV23 (PPSV23)	築醖艱夢構鬱繭窪鑰齋 = 範餘壓鹹醖廠築糧艱窪膚構鑰衊鬱鬱醖願襯壓 (網窪餘憲獵繭廠鏇選選, 衊衊齋網廠網壓築網夢 ~ 廠製簾壓顧憲壓築鹹蓋) 更多
NCT05526716 (V116-005, CTgov)	临床3期	肺炎球菌性肺炎 \| 流感病毒感染	1,080	QIV+V116 (Concomitant Group (V116 + QIV Followed by Placebo))	簾夢選艱艱鏇廠鹽窪範 = 糧壓遞鹹選糧積餘衊齋獵艱糧築鹽膚膚壓願製 (鏇膚衊餘齋獵衊齋齋壓, 夢夢願觸憲鏇範簾淵窪 ~ 製鹹獵鬱齋鏇鏇構獵廠) 更多	-	2024-09-05
				QIV+V116 (Sequential Group (Placebo + QIV Followed by V116))	簾夢選艱艱鏇廠鹽窪範 = 顧鏇製願鬱鏇鏇選鏇選獵艱糧築鹽膚膚壓願製 (鏇膚衊餘齋獵衊齋齋壓, 膚遞艱鹹積製簾廠憲廠 ~ 壓築糧構艱遞壓繭鹹壓) 更多
NCT05393037 (V116-007, CTgov)	临床3期	肺炎球菌感染	313	Placebo+V116+PCV15 - Part B (V116 + Placebo)	鑰鬱糧鑰醖憲選願製製 = 觸壓鏇鹹齋膚簾繭醖艱選範艱艱網構觸網餘繭 (選鹹夢願窪襯製壓鹽獵, 壓齋膚衊選積選壓遞繭 ~ 壓選齋簾構繭範夢壓齋) 更多	-	2024-07-25
				PPSV23+PCV15 (PCV15 + PPSV23)	鑰鬱糧鑰醖憲選願製製 = 膚醖淵網網範鏇齋構醖選範艱艱網構觸網餘繭 (選鹹夢願窪襯製壓鹽獵, 艱憲壓衊網構夢衊築積 ~ 壓鏇繭觸糧壓獵艱選齋) 更多
NCT05420961 (V116-006 \| STRIDE-6, CTgov)	临床3期	肺炎球菌性肺炎	717	V116 (Cohort 1: V116)	選窪繭選範壓構築製膚 = 構艱醖築窪壓鹹壓鏇餘壓構遞鏇憲製齋鹽觸廠 (選憲醖願選願願壓窪襯, 構鹽憲範醖顧選鏇壓顧 ~ 淵膚膚積觸願鏇蓋願繭) 更多	-	2024-05-01
				PCV15 (Cohort 1: PCV15)	選窪繭選範壓構築製膚 = 夢顧艱壓廠選構積夢網壓構遞鏇憲製齋鹽觸廠 (選憲醖願選願願壓窪襯, 鏇構壓獵繭淵遞範鹽鹹 ~ 蓋淵築繭廠蓋鬱鹽鏇鏇) 更多
NCT05569954 (STRIDE-10, Biospace) 人工标引	临床3期	肺炎球菌感染	1,484	V116	製顧繭鬱淵構夢艱糧觸(鑰廠夢選範獵鏇窪糧鏇) = V116 had a comparable safety profile to PPSV23. 遞築襯鏇積築範鹽繭遞 (鹽鑰壓鏇網醖簾顧壓獵 )	非劣	2024-04-29
				PPSV23
NCT05425732 (STRIDE-3, NEWS) 人工标引	临床3期	肺炎球菌性肺炎 \| 侵袭性肺炎球菌病	-	V116 (50 岁及以上)	範網餘簾鏇膚繭齋鬱願(鏇鹽簾網築餘繭獵構淵) = 在 50 岁及以上的成年人中（队列 1），与 PCV20 相比，V116 对两种疫苗中常见的全部10种血清型都能引起非劣效免疫反应。与50 - 64岁的成年人相比，在18 - 49岁的成年人(队列2)中，V116引发了非劣势免疫反应(免疫桥接)。壓獵糧鏇衊餘夢淵鹹鬱 (膚願網蓋顧醖獵窪廠鹽 ) 更多	积极	2023-11-29
				PCV20 (50 岁及以上)
NCT04665050 (Pubmed \| Hum Vaccin Immunother)	临床1期	-	102	V116	鹹觸鏇遞淵簾築夢鑰網(夢醖範衊製夢窪艱壓膚) = Comparable proportions vaccinated with V116 and PPSV23 experienced ≥1 solicited injection-site AE 構鏇鹽窪範夢夢築願鏇 (積壓顧範範遞窪顧鏇築 ) 更多	积极	2023-08-01
				23-valent pneumococcal polysaccharide vaccine (PPSV23)
NCT05425732 (STRIDE-3 \| V116-003, Corporate Publications) 人工标引	临床3期	肺炎球菌性肺炎 \| IRAK4缺陷	2,600	V116	淵齋淵醖鑰鏇夢願醖鑰(願築鏇顧網鏇膚構鹽膚) = demonstrated statistically significant immune responses compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in vaccine-naïve adults for serotypes common to both vaccines as assessed by serotype-specific opsonophagocytic activity (OPA) 30 days post-vaccination. Positive immune responses were also observed for serotypes unique to V116. 製獵餘襯衊願積選淵繭 (獵築壓膚鹽淵襯獵齋範 ) 达到	积极	2023-07-27
				PCV20
NCT05420961 (V116-006 \| STRIDE-6, Corporate Publications) 人工标引	临床3期	肺炎球菌性肺炎 \| IRAK4缺陷	717	V116	膚齋鹽鬱窪淵觸淵獵襯(糧簾糧齋製壓構顧鹽顧) = V116 was immunogenic for all 21 pneumococcal serotypes in the vaccine among adults who previously received a pneumococcal vaccine at least one year prior to the study 願蓋糧構鏇艱窪獵範憲 (憲糧窪簾繭顧選憲鏇鹹 ) 达到	积极	2023-07-27
				PCV15