A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants

开始日期2020-09-09

申办/合作机构

Pfizer Inc.

100 项与 20价肺炎球菌结合疫苗（苏州微超生物）相关的临床结果

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100 项与 20价肺炎球菌结合疫苗（苏州微超生物）相关的转化医学

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100 项与 20价肺炎球菌结合疫苗（苏州微超生物）相关的专利（医药）

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项与 20价肺炎球菌结合疫苗（苏州微超生物）相关的文献（医药）

2024-09-01·VACCINE

Cost-effectiveness analysis of the 20-valent pneumococcal conjugate vaccine for the pediatric population in South Korea

Article

作者: Kim, Young-Soo ; Suk, In-Ae ; Lee, Ju-Yeon ; Byun, Bo-Kyung ; Park, Sun-Kyeong ; Kang, Dong-Won ; June Choe, Young ; Kim, Hak-Yeon

OBJECTIVES:

To evaluate the cost-effectiveness of the 20-valent pneumococcal conjugate vaccine (PCV20) compared to 13-valent pneumococcal conjugate vaccine (PCV13) for the pediatric population in Korea, where the four-dose vaccine coverage rate is over 97%.

METHODS:

We constructed a Markov model to calculate the cost and quality-adjusted life-years (QALYs) over 10 years. The health states were susceptible states; disease states, which included invasive pneumococcal diseases such as meningitis, bacteremia, pneumonia, and acute otitis media; and death attributable to pneumococcal disease. The annual incidence and mortality due to pneumococcal diseases were estimated based on the serotypes covered by PCV13 and PCV20, vaccine coverage rate, vaccine effectiveness, and population size. Vaccine, administration, and disease costs were included in the model.

RESULTS:

In the total population (n = 51,431,305), PCV20 prevented more pneumococcal diseases and deaths, resulting in a gain of 74,855 QALY over PCV13. Meanwhile, the PCV20 group spent $275,136,631 less than the PCV13 group. As PCV20 gained more QALYs but spent less on total medical costs than PCV13, PCV20 was dominant over PCV13.

CONCLUSIONS:

In the Korean population, PCV20 is a cost-effective and dominant option over PCV13. Our findings provide evidence for decision-making regarding the introduction of PCV20 in countries with high vaccine coverage.

2024-08-01·JOURNAL OF THE AMERICAN GERIATRICS SOCIETY

Changes in the cost‐effectiveness of pneumococcal vaccination and of programs to increase its uptake in U.S. older adults

Article

作者: Smith, Kenneth J ; Nowalk, Mary Patricia ; Altawalbeh, Shoroq M ; Lin, Chyongchiou J ; Wateska, Angela R ; Schaffner, William ; Zimmerman, Richard K ; Harrison, Lee H

Abstract:

Background:

Multiple factors, such as less complex U.S. adult pneumococcal recommendations that could increase vaccination rates, childhood pneumococcal vaccination indirect effects that decrease adult vaccination impact, and increased vaccine hesitancy (particularly in underserved minorities), could diminish the cost‐effectiveness of programs to increase pneumococcal vaccination in older adults. Prior analyses supported the economic favorability of these programs.

Methods:

A Markov model compared no vaccination and current recommendations (either 20‐valent pneumococcal conjugate vaccine [PCV20] alone or 15‐valent pneumococcal conjugate vaccine plus the 23‐valent pneumococcal polysaccharide vaccine [PCV15/PPSV23]) without or with programs to increase vaccine uptake in Black and non‐Black 65‐year‐old cohorts. Pre‐pandemic population‐ and serotype‐specific pneumococcal disease risk and illness/vaccine costs came from U.S. databases. Program costs were $2.19 per vaccine‐eligible person and increased absolute vaccination likelihood by 7.5%. Delphi panel estimates and trial data informed vaccine effectiveness values. Analyses took a healthcare perspective, discounting at 3%/year over a lifetime time horizon.

Results:

Uptake programs decreased pneumococcal disease overall. In Black cohorts, PCV20 without program cost $216,805 per quality‐adjusted life year (QALY) gained compared with no vaccination; incremental cost‐effectiveness was $245,546/QALY for PCV20 with program and $425,264/QALY for PCV15/PPSV23 with program. In non‐Black cohorts, all strategies cost >$200,000/QALY gained. When considering the potential indirect effects from childhood vaccination, all strategies became less economically attractive. Increased vaccination with less complex strategies had negligible effects. In probabilistic sensitivity analyses, current recommendations with or without programs were unlikely to be favored at thresholds <$200,000/QALY gained.

Conclusion:

Current U.S. pneumococcal vaccination recommendations for older adults were unlikely to be economically reasonable with or without programs to increase vaccine uptake. Alternatives to current pneumococcal vaccines that include pneumococcal serotypes associated with adult disease should be considered.

2024-07-01·Infectious Diseases and Therapy

Lifetime Health and Economic Burden of Invasive Pneumococcal Diseases Attributable to V116 Serotypes Among Adults in the United States

Article

作者: Owusu-Edusei, Kwame ; Johnson, Kelly D ; Yi, Zinan

INTRODUCTION:

This study aimed to estimate and compare the lifetime clinical and economic burden of invasive pneumococcal diseases (IPD) attributable to the serotypes contained in a new 21-valent pneumococcal conjugate vaccine (V116) vs. the 20-valent pneumococcal conjugate vaccine (PCV20) among adults aged 18 years and above in the USA.

METHODS:

A state-transition Markov model was used to track IPD cases and deaths as well as the associated direct medical costs (in 2023 US dollars) from a US healthcare payer perspective at 3% annual discount rate. The results were summarized for V116, PCV20, and eight unique serotypes contained in V116. A sensitivity analysis was conducted to determine the most influential inputs on the overall total direct lifetime cost.

RESULTS:

For the total population of US adults aged 18 years and above in 2021 (approx. 258 million residents), the estimated lifetime numbers of cases of IPD, post-meningitis sequelae (PMS), and IPD-related deaths attributable to the serotypes contained in V116 were approximately 1.4 million, 17,608, and 186,200, respectively, with a total discounted lifetime direct cost of $32.6 billion. A substantial proportion (approx. 31%) of those were attributable to the unique eight serotypes. The corresponding estimates for PCV20 were approximately 35% lower-934,000, 11,500, and 120,000, respectively-with a total discounted direct lifetime cost of $21.9 billion.

CONCLUSION:

These results show that V116 serotypes (compared to PCV20) are associated with substantially higher clinical and economic burden of IPD. The addition of V116 to vaccination recommendations can help to reduce the residual burden of IPD in US adults.

项与 20价肺炎球菌结合疫苗（苏州微超生物）相关的新闻（医药）

2023-02-24

·药融圈

龙头 | 万泰生物：旨在覆盖更多，20价肺炎结合疫苗启动临床

▲3月15-16日生物医药创新者峰会 · 限时免费报名中注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。药融圈获悉：万泰生物于2023年2月13日公告，公司于2021年9月收到国家药监局（NMPA）核准签发的20价肺炎疫苗（PCV20，20-Valent Pneumococcal Conjugate Vaccine）的《临床试验批准通知书》。近日，20价肺炎疫苗已经启动I期临床试验，并完成首例受试者入组。本次20价肺炎球菌多糖结合疫苗I期临产研究计划入组256名志愿者，试验预计为期25个月，包括全程安全性评价和后续免疫原性评价。20价肺炎疫苗为公司与江苏坤力生物制药有限责任公司联合开发，系用肺炎球菌1、3、4、5、6A、6B、7F、8、9V、10A、11A、12F、14、15B、18C、19A、19F、22F、23F和33F型荚膜多糖分别与重组肺炎溶血素共价结合成多糖蛋白质结合物，再将20种多糖蛋白质结合物按一定比例配制成的20价肺炎疫苗，临床前动物实验结果显示该疫苗具有良好的安全性和免疫原性。药融云数据库，www.pharnexcloud.com显示：《肺炎20价候选疫苗许可使用协议》数据中，此前交易采用许可授权费+里程碑款项+许可费的支付方式，其中：（1）许可授权费：2000万元人民币一次性支付，不可退、不可抵扣；（2）里程碑款项：需在实现对应的里程碑事件后支付，共计4.8亿元人民币；（3）许可费：许可产品在中国启动首次商业化销售后的11个会计年度内（含首次实现销售收入的当个会计年度）支付，许可费率按净销售额的6%-8%，不同会计年度略有差异。（a）许可费率。许可产品在中华人民共和国上市后，万泰生物将按如下标准支付许可费用：i. 该许可产品实现销售收入当年及随后第 1-2 个会计年度，按净销售额的 8%向江苏坤力支付许可费； ii. 第 3-4 个会计年度，按净销售额的 7.5%向江苏坤力支付许可费； iii. 第 5-6 个会计年度，按净销售额的 7%向江苏坤力支付许可费；iv. 第 7-8 个会计年度，按净销售额的 6.5%向江苏坤力支付许可费；v. 第 9-10 个会计年度，按净销售额的 6%向江苏坤力支付许可费。（b）许可费期限。十个完整年度（自产品正式上市产生第一次连续销售收入之日算起），在许可产品在中华人民共和国启动首次商业化销售后的 11 个会计年度内（含首次实现销售收入的当个会计年度），万泰生物应根据相关约定支付许可费，期满后不再支付许可费。在全球范围内，肺炎球菌肺炎在70岁及以上老年人群中每年预计可导致约50万人死亡、3000万人感染。肺炎球菌结合疫苗是预防球菌所致肺炎的“防病利器”。本次临床研究应用的20价肺炎球菌结合疫苗(PCV20)是新一代我国自主研发的肺炎疫苗，采用了新型载体蛋白。用于6周龄及以上人群进行主动免疫接种，预防由疫苗中20种肺炎链球菌血清型引起的侵袭性疾病和肺炎。此文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场参考：NMPA/CDE；药融云数据，www.pharnexcloud.com；FDA/EMA/PMDA；相关公司公开披露；BD交易|万泰生物5亿元引进20价肺炎多糖蛋白结合疫苗；厦门万泰20价肺炎球菌多糖结合疫苗I期临床试验启动会在阜圆满召开，https://mp.weixin.qq.com/s/0erilVIPbfTM9tmRBE_pyw；等等。线下活动（点击即可查看）线上直播（点击即可查看）点分享点点赞点在看

疫苗临床1期临床研究

100 项与 20价肺炎球菌结合疫苗（苏州微超生物）相关的药物交易

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研发状态

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
肺炎球菌感染	临床3期	澳大利亚	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	比利时	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	捷克	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	丹麦	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	爱沙尼亚	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	芬兰	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	意大利	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	荷兰	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	挪威	Pfizer Inc.	2020-09-09
肺炎球菌感染	临床3期	波兰	Pfizer Inc.	2020-09-09

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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


NCT04546425 (CTgov)	临床3期	肺炎球菌感染	1,258	20vPnC (20vPnC: Primary Study Population)	選鏇網襯糧鏇選壓構顧(餘築顧壓範憲膚壓鹽獵) = 窪顧醖築窪膚夢鹹鑰網醖衊衊鹹觸蓋夢範襯製 (範廠願鬱顧齋淵獵艱齋, 顧壓廠築遞淵壓醖鏇淵 ~ 醖蓋廠窪膚壓繭構窪鏇) 更多	-	2023-05-15
				13vPnC (13vPnC: Primary Study Population)	選鏇網襯糧鏇選壓構顧(餘築顧壓範憲膚壓鹽獵) = 糧壓糧衊淵膚艱積遞遞醖衊衊鹹觸蓋夢範襯製 (範廠願鬱顧齋淵獵艱齋, 憲餘顧鏇獵鏇夢簾餘蓋 ~ 製遞築構齋獵選壓艱憲) 更多