20价肺炎球菌结合疫苗（辉瑞）(20-valent Pneumococcal Conjugate Vaccine(Pfizer)) - 在研适应症：侵袭性肺炎链球菌感染，中耳炎，肺炎球菌感染_专利_临床

概要

基本信息

药物类型

灭活疫苗、预防性疫苗、多价疫苗

+ [1]

别名

Multivalent Pneumococcal conjugate vaccine、Pneumococcal 20-valent Conjugate Vaccine、Pneumococcal conjugate vaccine

+ [13]

靶点-

作用机制

免疫刺激剂

治疗领域

感染耳鼻咽喉疾病呼吸系统疾病

在研适应症

侵袭性肺炎链球菌感染中耳炎肺炎球菌感染+ [5]

非在研适应症

新型冠状病毒感染流感病毒感染

原研机构

Wyeth Pharmaceuticals LLC

在研机构

Pfizer Inc.Wyeth Pharmaceuticals LLC

Pfizer Japan, Inc.

+ [4]

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (2021-06-08),

侵袭性肺炎球菌病

最高研发阶段(中国)临床申请批准

特殊审评优先审评 (美国)、突破性疗法 (美国)、快速通道 (美国)

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结构/序列

Sequence Code 1148399

关联

40

项与 20价肺炎球菌结合疫苗（辉瑞）相关的临床试验

NCT06760208

/ Not yet recruitingN/A

Korean Post-marketing Surveillance for Prevenar 20

The purpose of this study is to understand the safety of Prevenar 20 (Pneumococcal 20-valent conjugate vaccine) once it is out in the Korean market. Prevenar 20 will be given to participants aged 6 weeks or older in Republic of Korea.
This study is seeking for participants who are:
* Infant, children and adolescents aged 6 weeks to under 18 years or adult who are 18 years or older
* Prescribed Prevenar 20 by their physician as per approved product label
All participants in this study will receive Prevenar 20 vaccine.
1 dose (0.5 mL) of Prevenar 20 will be given into a muscle, preferably to the shoulder muscle.
We will look at the experiences of people receiving the study medicine. This will help us see if the study medicine is safe.
Participants will take part in this study for 28 days. During this time, study doctor collects the data of subjects to understand the safety of study medicine. There is no strict fixed visit schedule. If subjects are unable to visit the study clinic 28 days after Prevenar 20 vaccine was given then the safety information will be collected by telephone or e-mail.

开始日期2025-09-01

申办/合作机构

Pfizer Inc.

NCT06806137

/ Not yet recruiting临床3期

A Phase 3a, Observer-blind, Randomized, Controlled, Study to Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, When Given as a Second Dose to Healthy Children, 3 Months After the Administration of a First Dose at 12 to 15 Months of Age

The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. The study will be conducted in children who have not previously contracted varicella or received a varicella vaccination.

开始日期2025-03-05

申办/合作机构

GSK Plc

CTRI/2024/12/077626

/ Not yet recruiting临床4期IIT

A Phase IV, Open labelled, Randomized, Controlled Study to Assess the Immunogenicity and Effect on Pneumococcal Nasopharyngeal Carriage of reduced two dose schedule (1+1) of Pneumococcal Conjugate Vaccines 10-valent PNEUMOSIL and 14 valent PNEUBEVAX-14 as compared to their recommended three dose schedule (2+1) in Healthy Indian Infants. - NIL

开始日期2025-01-01

申办/合作机构-

100 项与 20价肺炎球菌结合疫苗（辉瑞）相关的临床结果

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100 项与 20价肺炎球菌结合疫苗（辉瑞）相关的转化医学

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100 项与 20价肺炎球菌结合疫苗（辉瑞）相关的专利（医药）

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3,180

项与 20价肺炎球菌结合疫苗（辉瑞）相关的文献（医药）

2025-12-31·Expert Review of Vaccines

Economic evaluation of childhood pneumococcal conjugate vaccination programs in Qinghai and Hainan provinces, China

Article

作者: Wang, Chaofan ; Zhang, Haijun ; Deloria Knoll, Maria ; Wahl, Brian ; Lai, Xiaozhen ; Zhang, Haonan ; Fang, Hai

BACKGROUND:

The burden of pneumococcal disease varies regionally in China, disproportionately affecting children in many provinces such as Qinghai and Hainan. Nevertheless, the absence of a pneumococcal conjugate vaccine (PCV) in the National Immunization Program (NIP) or local programs presents limited coverage. This study evaluated the health and economic impact of including PCV in immunization programs in Qinghai and Hainan.

RESEARCH DESIGN AND METHODS:

A decision tree Markov model was constructed to simulate health outcomes and lifetime costs among children under different 13-valent PCV (PCV13) vaccination strategies compared to current practices, from societal and healthcare perspectives. Data on epidemiology, vaccine efficacy, cost, and utility were obtained from the literature and open databases. Sensitivity analyses were conducted to explore parameter uncertainty.

RESULTS:

Including three-dose PCV13 in provincial programs at NIP coverage (98.91%) could avert 7100 episodes and 118 deaths in Qinghai, and 6200 episodes and 66 deaths in Hainan. It was cost-effective at the $68.2/dose in private market and cost-saving at the United Nations Children's Fund (UNICEF) recommended $25/dose for both provinces. Increasing coverage to 50% or 75% was also cost-effective. Sensitivity analyses confirmed the robustness of the results despite parameter uncertainty.

CONCLUSIONS:

Prioritizing PCV13 in immunization programs in Qinghai and Hainan could effectively reduce disease burden, improve population health, and promote health equity.

2025-12-31·Expert Review of Vaccines

Serotype-specific serum immunoglobulin G at 18 months of age following one or two doses of a primary series of 10-valent or 13-valent pneumococcal conjugate vaccine and a booster dose at nine months of age: a randomized controlled study

Article

作者: Cutland, Clare L. ; Madhi, Shabir A. ; Nana, Amit J ; Koen, Anthonet ; Jose, Lisa ; Olwagen, Courtney ; Mutsaerts, Eleanora Aml ; Izu, Alane

BACKGROUND:

Due to high costs of pneumococcal conjugate vaccines (PCV), transitioning from a two (2 + 1) to a single dose (1 + 1) primary series with a booster should be considered. This study evaluated the immune response at 18 months of age following a 1 + 1 compared to a 2 + 1 schedule of 10-valent (PCV10) and 13-valent (PCV13) vaccines.

RESEARCH DESIGN AND METHODS:

A single-center, open-label, randomized trial conducted in Soweto, South Africa, evaluated the immunogenicity of differing dosing schedule for PCV10 and PCV13. Six hundred children were randomly assigned to six study arms (1:1:1:1:1:1). Non-inferiority was concluded when the lower limit of the 96% confidence interval of the ratio of geometric mean concentrations (GMCs) of the 1 + 1 and 2 + 1 schedules was >0.5 for at least 10 and eight of the PCV13 and PCV10 serotypes, respectively.

RESULTS:

GMCs in children who received the PCV13_6w + 1 and PCV13_14w + 1 schedule were non-inferior for 11 and 10 of the PCV13 serotypes, respectively, compared with the PCV13_2 + 1 arm. For PCV10, GMCs for both 1 + 1 schedules were non-inferior to a 2 + 1 schedule for nine of the PCV10 serotypes.

CONCLUSION:

Transitioning to a 1 + 1 schedule should be considered for early immunization programs.

CLINICAL TRIAL REGISTRATION:

www.clinicaltrials.gov identifier is NCT02943902.

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. ; Johnson, Kelly D. ; Tajima, Atsushi ; 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.

218

项与 20价肺炎球菌结合疫苗（辉瑞）相关的新闻（医药）

2025-02-05

·PMLiVE

Merck’s adult-specific pneumococcal vaccine Capvaxive recommended by CHMP

Merck & Co’s – known as MSD outside the US and Canada – adult-specific 21-valent pneumococcal conjugate vaccine has been recommended for approval by the European Medicines Agency’s human medicines committee. The Committee for Medicinal Products for Human Use (CHMP) has recommended that Capvaxive be used to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals aged 18 years and older. Diseases caused by Streptococcus pneumoniae bacteria are currently considered a “major public health problem” by the World Health Organization (WHO). There are more than 100 different types of pneumococcal bacteria and Merck’s Capvaxive, which is administered in a single dose, is specifically designed to help protect against the ones that are responsible for the majority of adult invasive pneumococcal disease, including eight strains not covered by any other approved pneumococcal vaccine. The CHMP’s recommendation was based on results from the late-stage STRIDE-3 trial, which compared Capvaxive to Pfizer’s 20-valent vaccine (PCV20) in adults who had not previously received a pneumococcal vaccine. Capvaxive elicited non-inferior immune responses compared to PCV20 for all ten serotypes common to both vaccines in adults aged 50 years and older, and generated superior immune responses for ten of its 11 unique serotypes. Additionally, Merck’s vaccine elicited non-inferior immune responses in adults aged 18 to 49 years compared to those aged 50 to 64 years and had a safety profile comparable to PCV20. The recommendation was also supported by results from the phase 3 STRIDE-4, STRIDE-5, STRIDE-6, STRIDE-7 and STRIDE-10 trials. The European Commission (EC) will now review the positive opinion as it makes a final decision on Capvaxive, which is expected by the second quarter of 2025. Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories, said: “This positive opinion is yet another testament to the clinical profile of Capvaxive and brings us a step closer to helping protect adults in the EU against pneumococcal disease. “Invasive pneumococcal disease can lead to serious consequences, including hospitalisation, organ damage and even death. We are pleased with the CHMP recommendation and look forward to the EC’s decision.”

临床结果临床3期疫苗上市批准

2025-02-02

·药明康德

默沙东研发疫苗有望在欧盟获批上市

▎药明康德内容团队编辑默沙东公司（MSD）日前宣布，欧洲药品管理局（EMA）人用药品委员会（CHMP）已建议批准Capvaxive（21价肺炎球菌结合疫苗）上市，用于对18岁及以上人群的主动免疫，以预防由肺炎链球菌（Streptococcus pneumoniae）引起的侵袭性疾病和肺炎。 Capvaxive专为成年人设计，涵盖导致50岁及以上成年人中约84%侵袭性肺炎球菌疾病的血清型。去年6月，它获得美国FDA批准上市。 Capvaxive的预防效力得到关键性3期临床试验STRIDE-3数据的验证。该研究评估了Capvaxive与活性对照药物PCV20（肺炎球菌20价结合疫苗）相比，在以前未接种过肺炎球菌疫苗的成人中的免疫原性、耐受性和安全性。该试验主要终点的分析显示，根据第30天血清型特异性调理吞噬活性（OPA）几何平均滴度（GMTs）的测量结果，在50岁及以上成人（队列1）中，Capvaxive与活性对照药物共有的所有10种血清型中，Capvaxive引起的免疫应答呈现非劣效性。根据第30天OPA GMT的测定结果以及从第1天至第30天OPA升高≥4倍的患者比例，Capvaxive中包含的其中11种血清型中有10种展现良好的免疫应答，活性对照疫苗不包含这11种血清型。此外，根据接种后30天血清型特异性OPA GMTs的评估，与50-64岁的成人相比，18-49岁的成人（队列2）中Capvaxive引起的免疫应答展现非劣效性。 Capvaxive是一种21价肺炎球菌结合疫苗。该疫苗专门设计用于预防主要导致成人肺炎球菌疾病的肺炎链球菌血清型，包括8种独特的血清型。Capvaxive设计为单剂给药，有助于预防成人侵袭性肺炎球菌疾病和肺炎球菌肺炎。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Merck Receives Positive EU CHMP Opinion for CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Pneumococcal Vaccination in Adults. Retrieved January 31, 2025, from https://www-merck-com.libproxy1.nus.edu.sg/news/merck-receives-positive-eu-chmp-opinion-for-capvaxive-pneumococcal-21-valent-conjugate-vaccine-for-pneumococcal-vaccination-in-adults/ 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

疫苗上市批准临床3期临床结果

2025-01-31

·merck.com

Merck Receives Positive EU CHMP Opinion for CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Pneumococcal Vaccination in Adults

January 31, 2025 6:45 am ET RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. The CHMP’s recommendation will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU), Iceland, Liechtenstein and Norway, and a final decision is expected by the second quarter of 2025. “Invasive pneumococcal disease and pneumococcal pneumonia remain critical public health challenges worldwide,” said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories. “This positive opinion is yet another testament to the clinical profile of CAPVAXIVE and brings us a step closer to helping protect adults in the EU against pneumococcal disease. Invasive pneumococcal disease can lead to serious consequences including hospitalization, organ damage and even death. We are pleased with the CHMP recommendation and look forward to the European Commission’s decision.” CAPVAXIVE is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease (IPD) cases. Based on country-level data from the following four EU countries, the serotypes covered by CAPVAXIVE are responsible for more cases of IPD in adults compared to PCV20 (pneumococcal 20-valent conjugate vaccine): Coverage of Serotypes Responsible for IPD in Select EU Countries Country Age Year Reported CAPVAXIVE PCV20 Germany ≥60 2020 ~84% ~58% France >65 2022 ~85% ~63% Italy >65 2023 ~77% ~64% Spain >65 2020 ~82% ~62% Data were included for select countries based on EU membership, population size and the most recent year reported. These values are based on country-level epidemiologic data and regional variations may exist; these values do not reflect the efficacy of the respective vaccines. There are currently no studies comparing the efficacy of CAPVAXIVE and PCV20. Among the clinical data supporting the recommendation are results from the pivotal Phase 3 STRIDE-3 trial (NCT05425732), which evaluated CAPVAXIVE compared to PCV20 in adults 18 years of age and older who had not previously received a pneumococcal vaccine. The recommendation is also supported by results from the Phase 3 STRIDE-4 (NCT05464420), STRIDE-5 (NCT05526716), STRIDE-6 (NCT05420961), STRIDE-7 (NCT05393037) and STRIDE-10 (NCT05569954) trials, evaluating CAPVAXIVE in vaccine-naïve and vaccine-experienced adults. If approved in the EU, it would mark the fourth authorization of CAPVAXIVE for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. CAPVAXIVE was first approved in the U.S. in June 2024, in Canada in July 2024, and in Australia in January 2025. In addition, CAPVAXIVE is currently under review in Japan, and other worldwide regulatory filings are underway. CAPVAXIVE Indication in the U.S. CAPVAXIVE is indicated in the U.S. for: Active immunization for the prevention of invasive disease and pneumonia caused byStreptococcus pneumoniaeserotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in adults individuals 18 years of age and older; Active immunization for the prevention of pneumonia caused byS. pneumoniaeserotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older. CAPVAXIVE should not be administered to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid; see additional Select Safety Information below. The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Selected Safety Information for CAPVAXIVE in the U.S. Do not administer CAPVAXIVE to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid. Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE. The most commonly reported (>10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%). The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%). Vaccination with CAPVAXIVE may not protect all vaccine recipients. About CAPVAXIVE In the U.S., CAPVAXIVE is Merck’s FDA approved 21-valent pneumococcal conjugate vaccine indicated for active immunization for the prevention of invasive disease and pneumonia in adults 18 years of age and older. CAPVAXIVE is specifically designed to help address Streptococcus pneumoniae serotypes predominantly responsible for adult invasive pneumococcal disease (IPD), including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B compared to other pneumococcal vaccines. CAPVAXIVE is administered as a single dose. About Pneumococcal Disease Pneumococcal disease is an infection caused by a bacteria called Streptococcus pneumoniae . There are about 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children. Pneumococcal disease can be invasive or non-invasive. Non-invasive pneumococcal illnesses include pneumonia (when pneumococcal disease is confined to the lungs), whereas invasive pneumococcal illnesses include pneumococcal bacteremia (infection in the bloodstream), bacteremic pneumococcal pneumonia (pneumonia with bacteremia) and pneumococcal meningitis (infection of the coverings of the brain and spinal cord). Pneumococcal pneumonia is a type of bacterial pneumonia, which is the most common clinical presentation of pneumococcal disease in adults. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). Please see Prescribing Information for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) at https://www-merck-com.libproxy1.nus.edu.sg/product/usa/pi_circulars/c/capvaxive/capvaxive_pi.pdf and Patient Information/Medication Guide for CAPVAXIVE at https://www-merck-com.libproxy1.nus.edu.sg/product/usa/pi_circulars/c/capvaxive/capvaxive_ppi.pdf . Media: Olivia Finucane 0044 7881 262476 Olivia.finucane@msd.com Chrissy Trank (640) 650-0694 chrissy.trank@merck.com Investor: Peter Dannenbaum (732) 594-1579 peter.dannenbaum@merck.com Damini Chokshi (732) 594-1577 damini.chokshi@merck.com

上市批准临床3期临床结果疫苗

100 项与 20价肺炎球菌结合疫苗（辉瑞）相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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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
侵袭性肺炎链球菌感染	韩国	Pfizer Pharmaceuticals Korea Ltd.	2024-10-31
中耳炎	美国	Wyeth Pharmaceuticals LLC	2023-04-27
肺炎球菌感染	加拿大	Pfizer Canada ULC	2022-05-09
肺炎球菌性肺炎	欧盟	Pfizer Europe MA EEIG	2022-02-14
肺炎球菌性肺炎	冰岛	Pfizer Europe MA EEIG	2022-02-14
肺炎球菌性肺炎	列支敦士登	Pfizer Europe MA EEIG	2022-02-14
肺炎球菌性肺炎	挪威	Pfizer Europe MA EEIG	2022-02-14
侵袭性肺炎球菌病	美国	Wyeth Pharmaceuticals LLC	2021-06-08

未上市

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适应症	最高研发状态	国家/地区	公司	日期
急性中耳炎	申请上市	欧盟	Pfizer Europe MA EEIG	2024-01-26
呼吸道合胞体病毒感染	申请上市	美国	Pfizer Inc.	2023-05-17
新型冠状病毒感染	临床3期	美国	Pfizer Inc.	2021-05-20
流感病毒感染	临床3期	美国	Pfizer Inc.	2020-09-01
肺部感染	临床2期	美国	Pfizer Inc.	2023-06-05

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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


NCT05886777 (CTgov)	临床2期	新型冠状病毒感染 \| 肺部感染	1,142	QIV+RSVpreF (Group 1: [RSVpreF + BNT162b2] + QIV)	餘製製積鬱鹹觸襯糧糧(願醖糧糧壓網淵衊醖製) = 築齋獵製齋簾醖膚膚積醖鏇衊構觸鬱鹹獵觸鏇 (蓋鏇蓋鹽製夢壓餘製廠, 製積襯齋壓餘遞鬱範憲 ~ 鹽糧蓋餘鏇憲鹹鬱獵齋) 更多	-	2024-12-18
				Placebo+BNT162b2+RSVpreF (Group 2: [RSVpreF+BNT162b2] + Placebo)	餘製製積鬱鹹觸襯糧糧(願醖糧糧壓網淵衊醖製) = 廠醖衊鹽築夢糧製窪製醖鏇衊構觸鬱鹹獵觸鏇 (蓋鏇蓋鹽製夢壓餘製廠, 繭構製鏇艱鏇範衊觸憲 ~ 觸鹹廠顧遞衊襯觸獵糧) 更多
NCT05875727 (CTgov)	临床3期	肺炎球菌感染	405	Pneumococcal vaccine (Cohort 1: 18 to 49 Years)	廠選築餘鏇蓋鹽艱鏇糧(夢鹹選範範鑰齋鬱窪繭) = 憲鹽選簾顧鑰製築鹹網鬱鹹餘廠觸顧觸餘鏇獵 (憲鑰襯淵憲鬱衊網糧鏇, 憲壓淵齋遞鑰鹽鏇夢築 ~ 遞夢淵顧餘鹹壓衊廠選) 更多	-	2024-10-24
				Pneumococcal vaccine (Cohort 2: >= 50 Years)	廠選築餘鏇蓋鹽艱鏇糧(夢鹹選範範鑰齋鬱窪繭) = 簾鑰鏇構製網構繭鹹簾鬱鹹餘廠觸顧觸餘鏇獵 (憲鑰襯淵憲鬱衊網糧鏇, 網窪顧鹽製夢築觸選繭 ~ 衊膚蓋遞築衊齋衊選範) 更多
NCT05408429 (CTgov)	临床3期	肺炎球菌感染	356	20vPnC (2-Dose 20vPnC)	鏇築觸網壓願積鬱淵繭(廠膚襯選膚選壓觸範積) = 構築獵鏇膚鏇願廠製積積衊鬱繭衊選鹹製積構 (憲鏇夢廠衊窪餘築膚鏇, 憲獵鹽製構願獵顧鹽艱 ~ 廠網蓋顧壓醖齋夢廠壓) 更多	-	2024-09-19
				20vPnC (1-Dose 20vPnC)	鏇築觸網壓願積鬱淵繭(廠膚襯選膚選壓觸範積) = 窪簾遞窪衊憲壓選鹹醖積衊鬱繭衊選鹹製積構 (憲鏇夢廠衊窪餘築膚鏇, 範構壓膚選積鏇鹽淵蓋 ~ 衊窪願築艱網窪餘願窪) 更多
NCT04382326 (CTgov)	临床3期	肺炎球菌感染	1,997	20-valent Pneumococcal Conjugate Vaccine (20vPnC) (20vPnC)	積構齋遞鏇願範繭鏇鏇(觸衊網壓壓觸製範艱繭) = 糧選願選鹽選襯鏇醖醖顧衊願範繭膚窪醖餘築 (構簾顧觸遞憲築鹽餘憲, 淵築鏇襯鬱製膚築構繭 ~ 製積醖顧鹹獵夢鹽夢獵) 更多	-	2023-12-06
				13-valent Pneumococcal Conjugate Vaccine (13vPnC) (13vPnC)	積構齋遞鏇願範繭鏇鏇(觸衊網壓壓觸製範艱繭) = 窪襯糧憲鹹鏇顧醖襯餘顧衊願範繭膚窪醖餘築 (構簾顧觸遞憲築鹽餘憲, 齋鹹淵鏇簾廠鹹繭構鏇 ~ 繭獵壓齋醖製積獵餘壓) 更多
NCT04379713 (CTgov)	临床3期	肺炎球菌感染	1,511	20vPnC (20vPnC)	醖廠顧餘願積壓襯糧遞(製夢窪觸簾選積顧窪網) = 餘鹽顧觸製壓積構獵願憲夢鑰糧廠廠夢窪簾構 (繭繭鬱膚觸鏇範夢餘範, 積繭顧齋膚鏇糧鑰構簾 ~ 築夢鹹夢艱蓋齋醖築糧) 更多	-	2023-06-13
				13vPnC (13vPnC)	醖廠顧餘願積壓襯糧遞(製夢窪觸簾選積顧窪網) = 壓壓觸鏇範醖鏇選鹹憲憲夢鑰糧廠廠夢窪簾構 (繭繭鬱膚觸鏇範夢餘範, 簾構觸艱顧鏇網鹽醖鬱 ~ 壓積願製淵築齋顧築夢) 更多
NCT04642079 (CTgov)	临床3期	肺炎球菌感染	839	20vPnC+13vPnC (Cohort 1: 20vPnC: >=15 to <24 Months)	鬱蓋願艱蓋廠獵廠鹽夢(膚顧膚觸構網艱淵觸餘) = 獵繭衊醖窪夢衊網遞艱夢蓋願蓋鬱齋蓋憲廠觸 (憲鹽艱繭窪遞膚願遞獵, 獵壓獵觸顧簾鬱遞齋繭 ~ 糧醖網簾糧繭鹽糧選廠) 更多	-	2023-04-26
				20vPnC+13vPnC (Cohort 2: 20vPnC: >=2 to <5 Years)	鬱蓋願艱蓋廠獵廠鹽夢(膚顧膚觸構網艱淵觸餘) = 廠憲膚鹹糧顧繭範淵壓夢蓋願蓋鬱齋蓋憲廠觸 (憲鹽艱繭窪遞膚願遞獵, 願襯衊鹹選餘淵糧積鏇 ~ 選憲膚餘觸鑰夢築簾願) 更多
NCT04530838 (CTgov)	临床3期	肺炎球菌感染	668	20vPnC (20vPnC (SC))	選積構獵齋鏇獵齋淵選(醖窪鑰網鏇醖鹽餘積繭) = 遞觸構蓋願鹽繭窪夢願簾艱鑰夢壓窪鑰夢築鬱 (壓夢廠獵繭齋鬱鹹網壓, 顧憲獵鑰築憲餘獵獵顧 ~ 憲構鑰憲鏇衊糧獵衊艱) 更多	-	2023-04-21
				13vPnC (13vPnC (SC))	選積構獵齋鏇獵齋淵選(醖窪鑰網鏇醖鹽餘積繭) = 糧遞鬱糧餘築獵範積鑰簾艱鑰夢壓窪鑰夢築鬱 (壓夢廠獵繭齋鬱鹹網壓, 淵鬱鬱鹽窪鬱膚遞網鑰 ~ 糧鑰廠齋壓廠膚築鏇顧) 更多
NCT04887948 (CTgov)	临床3期	新型冠状病毒感染 \| 肺炎球菌感染	570	BNT162b2+20vPnC (Coadministration Group (20vPnC+BNT162b2): 20vPnC Vaccination Site)	夢築鹹艱窪願選獵鹹鬱(網觸衊顧夢鹹壓築襯齋) = 願餘製醖構壓鹹製顧鑰夢鏇選淵築蓋壓獵廠構 (鬱鹹選蓋範蓋構鏇製憲, 選願醖遞壓遞觸顧獵糧 ~ 淵積壓鹹鏇鑰醖蓋築積) 更多	-	2022-12-14
				BNT162b2+20vPnC (Coadministration Group (20vPnC+BNT162b2): BNT162b2 Vaccination Site)	夢築鹹艱窪願選獵鹹鬱(網觸衊顧夢鹹壓築襯齋) = 構簾壓醖衊衊夢製繭鏇夢鏇選淵築蓋壓獵廠構 (鬱鹹選蓋範蓋構鏇製憲, 衊憲蓋鏇鹽淵顧壓顧積 ~ 築築蓋遞窪鹹鑰窪鏇選) 更多
NCT04546425 (Corporate Publications) 人工标引	临床3期	肺炎球菌感染	-	20-Valent Pneumococcal Conjugate Vaccine	壓淵襯鹽衊膚網糧蓋觸(鑰選廠淵鹽壓餘積壓觸) = The safety profile of 20vPnC was favorable and similar to Prevenar 13® (or Prevnar 13® in the U.S.) in this schedule, and concomitant use with common pediatric vaccines was supported and well tolerated 齋選襯膚壓鑰願鏇醖襯 (衊鬱鹹壓鑰鏇憲糧遞製 )	非劣	2022-09-19
				Prevenar 13
NCT04382326 (Corporate Publications) 人工标引	临床3期	IRAK4缺陷	-	20-Valent Pneumococcal Conjugate Vaccine	選窪積壓構鏇糧壓鏇窪(膚醖糧構網製襯廠醖夢) = A similar percentage of infants receiving either vaccine experienced local reactions (pain at the injection site, redness, and swelling), fever, and other systemic events (decreased appetite, drowsiness, and irritability) 衊淵積膚憲鬱憲夢選蓋 (鏇齋築範艱製顧壓鑰鑰 )	非劣	2022-08-12
				Pneumococcal polysaccharide conjugate vaccine