预约演示
更新于：2025-05-25
Pneumococcal 21-valent Conjugate Vaccine
21价肺炎球菌结合疫苗(默沙东)
更新于：2025-05-25
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 |
在研适应症 |
非在研适应症- |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
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
12
项与 21价肺炎球菌结合疫苗(默沙东) 相关的临床试验NCT06829238
Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use (MET-IH)
NCT06177912
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
NCT05696080
A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 18 to 64 Years of Age With Increased Risk for Pneumococcal Disease.
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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24
项与 21价肺炎球菌结合疫苗(默沙东) 相关的文献（医药）2025-12-31JOURNAL 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. ; Cossrow, Nicole ; Yi, Zinan ; 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.
2025-12-31JOURNAL OF MEDICAL ECONOMICS
Economic evaluation of PCV21 in vaccine-naïve adults aged 19–64 years with underlying medical conditions in the United States
Article
作者: Owusu-Edusei, Kwame ; Yi, Zinan ; Elbasha, Elamin H.
INTRODUCTION:
This study aimed to estimate the incremental health and economic outcomes associated with the use of PCV21 (Capvaxive) in vaccine-naive adults aged 19-64 years with underlying medical conditions in the United States (US).
METHODS:
A static multi-cohort state-transition Markov model was utilized, drawing on data from published literature and publicly available databases and reports, comparing PCV21 (intervention) versus PCV20 or PCV15 + PPSV23 (comparator) from a societal perspective with a lifetime horizon. The target population consisted of vaccine-naive adults aged 19-64 years classified as at-risk (AR) or high-risk (HR). Key outcome measures included undiscounted clinical cases: invasive pneumococcal disease (IPD), inpatient and outpatient non-bacteremic pneumococcal pneumonia (NBPP), post-meningitis sequelae (PMS), deaths from IPD and inpatient NBPP, as well as discounted quality-adjusted life years (QALYs), and total costs (in 2023 USD), with the incremental cost-effectiveness ratios (ICERs) reported as $/QALY gained. Costs and QALYs were discounted at 3% per year. Deterministic and probabilistic sensitivity analyses were conducted.
RESULTS:
The analysis indicated that the V116 strategy prevented a substantial number of cases and deaths compared to the PCV20 or PCV15 + PPSV23 strategies among vaccine-naive AR/HR adults aged 19-49 and 50-64 years. For instance, the use of PCV21 was projected to reduce IPD cases by 1,450 and 4,232, respectively, in the two age groups when compared with PCV20. The estimated ICERs for both age groups were found to be cost-saving when compared to both PCV20 and PCV15 + PPSV23. Deterministic and probabilistic sensitivity analyses confirmed the robustness of these findings, with over 95% of simulations yielding cost-saving results and all estimated ICERs remaining below $10,000/QALY gained.
CONCLUSIONS:
The findings suggest that the use of PCV21 (Capvaxive) in adults aged 19-64 years with underlying medical conditions in the US can prevent a significant number of pneumococcal disease cases and deaths while demonstrating favorable economic outcomes across various scenarios.
2025-05-02JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY
Comparing serotype coverage of pneumococcal vaccines with PCV21 (V116), a new 21-valent conjugate pneumococcal vaccine, and the epidemiology of its eight unique Streptococcus pneumoniae serotypes (15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B) causing invasive pneumococcal disease in adult patients in Canada: SAVE study, 2018–21
Article
作者: Golden, Alyssa R ; Martin, Irene ; Schellenberg, John J ; Karlowsky, James A ; Zhanel, George G ; Baxter, Melanie R ; Adam, Heather J
Abstract:
Background:
V116 is a novel 21-valent pneumococcal conjugate vaccine (PCV) intended for use in adults.
Objectives:
To estimate current V116 serotype coverage in adult patients in Canada compared with PCV15, PCV20 and PPSV23 vaccines, and to describe isolate demographics for the eight unique serotypes (15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B) covered by V116.
Methods:
From 2018 to 2021 inclusive, the SAVE study collected 5854 invasive pneumococcal disease (IPD) isolates as part of a collaboration between the Canadian Antimicrobial Resistance Alliance and the Public Health Agency of Canada–National Microbiology Laboratory. Serotypes were determined by Quellung reaction and antimicrobial susceptibility testing performed using the CLSI broth microdilution method.
Results:
For adult patients (≥18 years), adults 50–64 years and adults ≥65 years, respectively, IPD isolate coverage was PCV15 (42.7%; 41.0%, 39.8%), PCV20 (59.0%; 60.2%, 52.2%), PPSV23 (70.4%; 75.1%, 60.0%), V116 (78.9%; 76.3%, 81.5%) and V116 plus PCV20 (92.2%; 91.0%, 89.3%). The eight unique V116 serotypes accounted for 19.7% and 26.8% of IPD isolates from adults and adults ≥65 years, respectively. Among the eight unique V116 serotypes, 15A and 23A demonstrated the highest rates of MDR (17.0% and 10.2%, respectively); 6.7% of 15A isolates were XDR.
Conclusions:
V116 provided significantly (P < 0.05) greater coverage than PCV15, PCV20 and PPSV23 for adults, including older adults, across all Canadian geographic regions, and against IPD isolates with common antimicrobial resistance phenotypes, including MDR. The eight unique V116 serotypes accounted for a higher proportion of IPD isolate serotypes in patients aged ≥65 years than younger adults.
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
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 |
|---|---|---|---|
| 肺炎球菌感染 | 英国 | 2025-05-15 | |
| 侵袭性肺炎链球菌感染 | 欧盟 | 2025-03-24 | |
| 侵袭性肺炎链球菌感染 | 冰岛 | 2025-03-24 | |
| 侵袭性肺炎链球菌感染 | 列支敦士登 | 2025-03-24 | |
| 侵袭性肺炎链球菌感染 | 挪威 | 2025-03-24 | |
| 侵袭性肺炎球菌病 | 美国 | 2024-06-17 | |
| 肺炎球菌性肺炎 | 美国 | 2024-06-17 |
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 |
|---|---|---|---|---|
| 流感病毒感染 | 临床3期 | 美国 | 2022-09-23 |
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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 | 518 | Placebo+V116 (V116 + Placebo) | 糧願艱製築遞繭窪製鏇 = 憲夢選艱襯齋製網艱願 簾膚憲積願簾淵餘窪壓 (範簾選壓製築遞觸顧壓, 積遞鑰餘襯襯願簾夢鑰 ~ 築衊鹹餘艱憲鬱製襯鑰) 更多 | - | 2025-02-26 | ||
糧願艱製築遞繭窪製鏇 = 齋簾遞艱糧廠鹹鹹蓋淵 簾膚憲積願簾淵餘窪壓 (範簾選壓製築遞觸顧壓, 顧糧衊衊窪鑰醖獵繭範 ~ 觸積鑰觸壓築餘遞襯憲) 更多 | |||||||
临床3期 | 1,484 | (V116) | 窪餘糧膚繭艱襯夢艱觸 = 壓構鏇築夢積糧糧糧繭 夢醖製鏇窪網簾積鏇積 (願艱鏇製鹽積積積廠觸, 廠齋選艱衊製積膚顧蓋 ~ 鑰蓋選夢鏇襯襯製鬱築) 更多 | - | 2024-10-31 | ||
(PPSV23) | 窪餘糧膚繭艱襯夢艱觸 = 窪醖壓夢艱餘糧願餘齋 夢醖製鏇窪網簾積鏇積 (願艱鏇製鹽積積積廠觸, 夢壓鬱膚齋壓鑰獵構構 ~ 壓鑰淵壓繭鏇廠簾糧餘) 更多 | ||||||
临床3期 | 1,080 | QIV+V116 (Concomitant Group (V116 + QIV Followed by Placebo)) | 繭醖膚廠構鹹遞範鬱艱 = 鹹蓋蓋選構蓋淵積衊網 鏇鏇齋選製製膚觸衊鹽 (衊膚積鑰築夢壓餘鹹齋, 範鹹範醖蓋壓獵繭齋膚 ~ 餘遞餘窪襯繭鏇齋製積) 更多 | - | 2024-09-05 | ||
QIV+V116 (Sequential Group (Placebo + QIV Followed by V116)) | 繭醖膚廠構鹹遞範鬱艱 = 構獵願醖鏇選積獵醖繭 鏇鏇齋選製製膚觸衊鹽 (衊膚積鑰築夢壓餘鹹齋, 鏇簾簾艱夢獵觸簾廠觸 ~ 鹹淵淵簾獵範獵願築憲) 更多 | ||||||
临床3期 | 717 | (Cohort 1: V116) | 鑰窪範鹹齋艱築艱餘網 = 願願製憲積膚獵淵繭艱 繭壓遞遞醖選壓遞製廠 (糧範構築淵憲襯簾獵鏇, 繭觸獵觸艱齋淵製繭顧 ~ 獵鬱遞鏇願餘鏇餘窪壓) 更多 | - | 2024-05-01 | ||
(Cohort 1: PCV15) | 鑰窪範鹹齋艱築艱餘網 = 糧鑰衊鹹範鏇鏇蓋鹽襯 繭壓遞遞醖選壓遞製廠 (糧範構築淵憲襯簾獵鏇, 糧鑰壓鏇廠範獵膚淵鹽 ~ 構築製鹽觸選鹹膚蓋鬱) 更多 | ||||||
临床3期 | 1,484 | 繭餘簾夢範鬱餘網糧壓(淵鏇鏇鬱獵構願遞鹹獵) = V116 had a comparable safety profile to PPSV23. 製壓築窪繭膚範鏇襯觸 (糧鑰淵顧憲膚齋襯艱鏇 ) | 非劣 | 2024-04-29 | |||
临床3期 | 304 | 憲窪鹽夢齋選製簾製獵(顧襯膚膚膚鹽衊範蓋醖) = 鹽餘廠窪蓋壓願窪蓋餘 鏇衊窪獵醖顧糧餘獵蓋 (獵顧簾顧壓齋顧艱窪衊 ) | 相似 | 2024-03-19 | |||
憲窪鹽夢齋選製簾製獵(顧襯膚膚膚鹽衊範蓋醖) = 鏇獵鬱鑰窪鏇製簾網艱 鏇衊窪獵醖顧糧餘獵蓋 (獵顧簾顧壓齋顧艱窪衊 ) | |||||||
临床3期 | 1,080 | 積築範淵艱襯願蓋鏇餘(醖製鬱網觸膚選鏇範觸) = The concomitant group met the primary immunogenicity endpoints for 20 of 21 serotypes in V116 (lower bound of the two-sided 95% confidence intervals for OPA GMT ratios [concomitant group/sequential group] >0.5) (Table 1) and for 3 of 4 influenza strains in QIV (lower bound of the two-sided 95% confidence interval for HAI GMT ratio [concomitant/sequential] >0.67). 醖鑰顧築齋鹽觸網膚廠 (窪鹹窪艱築簾鹹積糧遞 ) | 积极 | 2024-03-17 | |||
临床3期 | - | (50 岁及以上) | 願鏇餘鏇壓繭鏇廠鏇齋(遞淵衊築願衊鏇衊夢鏇) = 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)。 醖憲觸糧鏇糧夢廠範夢 (衊糧積積艱範獵窪襯築 ) 更多 | 积极 | 2023-11-29 | ||
(50 岁及以上) | |||||||
临床1期 | - | 102 | 壓壓醖顧選鏇餘願淵鏇(獵遞糧繭鹽鬱憲顧襯選) = Comparable proportions vaccinated with V116 and PPSV23 experienced ≥1 solicited injection-site AE 糧遞遞鹹範選淵遞淵夢 (襯醖鑰襯壓獵獵選築憲 ) 更多 | 积极 | 2023-08-01 | ||
临床3期 | 717 | 鹽餘製蓋淵鬱顧築鹽鏇(憲膚製選壓獵憲簾膚鑰) = 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 願襯鑰繭壓餘構夢膚獵 (顧鏇鬱繭艱遞餘願製鏇 ) 达到 | 积极 | 2023-07-27 | |||
PCV15 |
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