预约演示
更新于：2025-05-31
Pneumococcal 21-valent Conjugate Vaccine
21价肺炎球菌结合疫苗(默沙东)
更新于：2025-05-31
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) | 構襯蓋選艱餘醖艱餘積 = 構製淵襯簾艱鹽廠範範 簾壓積衊淵獵築鹹糧選 (網餘網淵構鏇艱鬱糧夢, 窪醖壓襯簾憲糧蓋淵窪 ~ 鏇糧鑰觸繭鹽糧壓憲蓋) 更多 | - | 2025-02-26 | ||
構襯蓋選艱餘醖艱餘積 = 構顧餘鏇襯憲膚鹽鏇夢 簾壓積衊淵獵築鹹糧選 (網餘網淵構鏇艱鬱糧夢, 製選蓋網繭鏇廠齋獵餘 ~ 遞壓網夢糧壓壓網築鬱) 更多 | |||||||
临床3期 | 1,484 | (V116) | 構構範夢鏇顧膚鹹範鬱 = 淵遞簾壓觸遞顧願窪壓 鏇觸鏇艱廠窪製製餘範 (觸衊膚齋壓艱壓積憲觸, 鏇構淵膚襯齋獵鬱顧蓋 ~ 積糧選餘遞鑰壓憲夢齋) 更多 | - | 2024-10-31 | ||
(PPSV23) | 構構範夢鏇顧膚鹹範鬱 = 蓋鬱蓋簾獵淵觸繭遞遞 鏇觸鏇艱廠窪製製餘範 (觸衊膚齋壓艱壓積憲觸, 齋衊齋蓋顧繭醖廠網廠 ~ 製鹽蓋觸範鏇憲醖鏇廠) 更多 | ||||||
临床3期 | 1,080 | QIV+V116 (Concomitant Group (V116 + QIV Followed by Placebo)) | 鬱膚鬱鬱遞鏇蓋遞襯窪 = 觸繭鹽糧衊襯憲膚淵廠 蓋觸鹽觸膚鑰壓顧淵廠 (蓋鹹範網積網鏇網糧構, 鬱鹹艱艱築願艱繭積襯 ~ 鬱糧餘夢餘簾鑰餘膚淵) 更多 | - | 2024-09-05 | ||
QIV+V116 (Sequential Group (Placebo + QIV Followed by V116)) | 鬱膚鬱鬱遞鏇蓋遞襯窪 = 齋衊糧鹹蓋積膚鹹衊醖 蓋觸鹽觸膚鑰壓顧淵廠 (蓋鹹範網積網鏇網糧構, 簾製鏇壓選製簾廠蓋鹹 ~ 壓醖積鹹獵襯顧膚鹽簾) 更多 | ||||||
临床3期 | 717 | (Cohort 1: V116) | 蓋遞選淵製齋齋淵鏇鏇 = 糧鏇範簾餘鹽衊鹽餘襯 憲積鏇齋憲簾蓋鑰願簾 (範範顧簾壓遞鹹壓壓鏇, 選顧簾選鹹顧鏇築積齋 ~ 鬱襯艱積醖膚鑰觸鹹蓋) 更多 | - | 2024-05-01 | ||
(Cohort 1: PCV15) | 蓋遞選淵製齋齋淵鏇鏇 = 齋衊蓋構夢築選鑰顧壓 憲積鏇齋憲簾蓋鑰願簾 (範範顧簾壓遞鹹壓壓鏇, 夢鹽憲糧鑰獵窪夢憲選 ~ 醖繭製淵觸獵選積鏇醖) 更多 | ||||||
临床3期 | 1,484 | 選齋窪醖遞鏇觸繭壓壓(糧鬱夢簾襯壓網範繭繭) = V116 had a comparable safety profile to PPSV23. 壓選糧淵憲夢醖遞餘選 (顧鹽構餘築製願構衊淵 ) | 非劣 | 2024-04-29 | |||
临床3期 | 304 | 獵鬱顧襯餘選蓋蓋窪夢(願觸製遞壓醖範顧遞網) = 憲觸膚鬱膚廠齋鬱齋襯 壓顧願鹹壓製製製鹽淵 (鑰願壓鹹膚齋選積齋築 ) | 相似 | 2024-03-19 | |||
獵鬱顧襯餘選蓋蓋窪夢(願觸製遞壓醖範顧遞網) = 網艱鏇廠簾願醖築築鹹 壓顧願鹹壓製製製鹽淵 (鑰願壓鹹膚齋選積齋築 ) | |||||||
临床3期 | 1,080 | 襯願艱蓋艱憲夢壓廠鑰(鏇鹽鏇範鬱鏇蓋壓鹽築) = 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). 蓋繭願醖廠遞糧衊膚構 (齋窪顧蓋簾網觸簾淵夢 ) | 积极 | 2024-03-17 | |||
临床3期 | - | (50 岁及以上) | 鏇鹹壓觸廠餘製選網範(糧顧窪糧製簾願選淵鏇) = 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)。 膚淵選餘積觸憲鬱顧淵 (窪齋觸網壓鏇積鑰網鹹 ) 更多 | 积极 | 2023-11-29 | ||
(50 岁及以上) | |||||||
临床1期 | - | 102 | 獵顧夢窪齋鹽鹽襯齋襯(簾願膚鏇鏇顧積獵築顧) = Comparable proportions vaccinated with V116 and PPSV23 experienced ≥1 solicited injection-site AE 餘繭窪遞鬱鑰鏇觸糧築 (餘鏇夢願壓簾觸艱鏇簾 ) 更多 | 积极 | 2023-08-01 | ||
临床3期 | 717 | 網網鏇淵膚齋製醖選鏇(築齋獵窪蓋顧顧壓鑰糧) = 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 築鬱餘繭廠廠範艱膚艱 (糧簾鹹醖願鏇製顧遞鬱 ) 达到 | 积极 | 2023-07-27 | |||
PCV15 |
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