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+ [4]

非在研适应症

流感病毒感染

原研机构

Wyeth Pharmaceuticals LLC

在研机构

Pfizer Japan, Inc.Pfizer Europe MA EEIG

Pfizer 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

特殊审评突破性疗法 (美国)、快速通道 (美国)、优先审评 (美国)

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序列信息

Sequence Code 1148399

关联

39

项与 20价肺炎球菌结合疫苗（辉瑞）相关的临床试验

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-

NCT06740630 / Not yet recruiting临床3期

A Phase 3a, Observer-blind, Randomized, Controlled Study to Demonstrate Lot-to-lot Consistency and Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, Administered as a First Dose to Healthy Children 12 to 15 Months of Age

The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.

开始日期2024-12-17

申办/合作机构

GSK Plc

NCT06622109 / Not yet recruitingN/A

PREVENAR 20 SUSPENSION LIQUID FOR INJECTION SPECIAL INVESTIGATION - Investigation in Infants Starting Vaccination at the Age of 2 Month, Inclusive, to 7 Months, Exclusive -

The purpose of this study is to learn about the safety of 20-valent Pneumococcal Conjugate Vaccine (PREVENAR 20) under actual clinical practice in Japan.
This study is seeking for infants aged between two months to six months who are vaccinated with PREVENAR 20 for the first time.
Infants aged between two months and six months are normally given four vaccinations. The first three vaccinations are called primary vaccinations and are given with an interval of one month between each vaccination. The fourth vaccination is called the booster and is given between 12 and 15 months of age.
Participants will take part in this study from the day of first vaccination to 28 days after fourth vaccination.
The side effects observed in the participants will be recorded and looked into.

开始日期2024-11-29

申办/合作机构

Pfizer Inc.

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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2,669

项与 20价肺炎球菌结合疫苗（辉瑞）相关的文献（医药）

2025-01-01·VACCINE

Cost-effectiveness of 15-valent or 20-valent pneumococcal conjugate vaccine for U.S. adults aged 65 years and older and adults 19 years and older with underlying conditions

Article

作者: Stoecker, Charles ; Kobayashi, Miwako ; Leidner, Andrew J ; Rosenthal, Melissa ; Pilishvili, Tamara ; Cho, Bo-Hyun

BACKGROUND:

In June 2021, the Advisory Committee on Immunization Practices (ACIP) recommended use of either 20-valent pneumococcal conjugate vaccine (PCV20) alone or 15-valent pneumococcal conjugate vaccine (PCV15) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23) for all PCV-unvaccinated adults aged ≥65 years (age-based) and for adults aged 19-64 years with conditions that increase the risk for pneumococcal disease (risk-based). This recommendation replaced a previous recommendation for PPSV23 with or without 13-valent pneumococcal conjugate vaccine (PCV13) for these groups.

OBJECTIVE:

We conducted a cost-effectiveness analysis of age-based and risk-based use of either PCV15 in series with PPSV23 or PCV20 alone when compared to previous recommendations.

METHODS:

We utilized probabilistic cohort models of all 65-year-olds (age-based) and 19-year-olds (risk-based through age 64 years and age-based at age 65 years). A spreadsheet-based Monte Carlo simulation software was used to estimate immunization costs, medical costs, non-medical costs, and overall disease burden under different vaccine strategies. The model tracked inpatient invasive pneumococcal disease (IPD) and non-bacteremic pneumonia (NBP) in inpatient and outpatient settings. One-way sensitivity analyses incorporated indirect effects of prospective pediatric vaccination with PCV15 and PCV20 on adult IPD and NBP incidence. Costs were reported in 2021 US dollars. All future costs and outcomes were discounted at 3 % per year.

RESULTS:

Age-based use of either PCV20 alone or PCV15 in series with PPSV23 at age 65 years were both shown to be cost-saving (improved health outcomes and saved costs). Combined cost-effectiveness of risk-based (19-64 years) plus age-based (65 years) (risk-and-age-based) use of PCV20 alone was cost-saving, whereas use of PCV15 in series with PPSV23 increased quality-adjusted life years (QALYs) but cost $412,111 (95 % CI: 270,295, 694,869) per QALY gained.

CONCLUSION:

In U.S. adults, replacing the previous recommendations with PCV20 alone or PCV15 in series with PPSV23 improved health outcomes. Except for risk-and-age-based use of PCV15 in series with PPSV23 that resulted in increased cost per QALY gained, the interventions also reduced costs.

2025-01-01·PEDIATRIC INFECTIOUS DISEASE JOURNAL

Severe Invasive Pneumococcal Disease Caused by Serotype 19A in Children Under Five Years in Tāmaki Makaurau Auckland, Aotearoa New Zealand

Article

作者: Burton, Cameron ; Humphrey, Alexander ; Best, Emma ; Anglemyer, Andrew ; Tuato’o, Amelie ; Webb, Rachel

Background::

Increases in childhood invasive pneumococcal disease (IPD) have been reported in several countries following the easing of COVID-19 pandemic mitigations. In Aotearoa New Zealand (AoNZ), a surge in IPD is occurring in young children concurrent with changes in pneumococcal vaccines and declining immunization coverage. We sought to examine epidemiologic and clinical features of IPD among children under 5 years in a large urban region of AoNZ in the 3 years post-COVID-19.

Methods::

Demographic, clinical and laboratory data were collated from children under 5 years with Streptococcus pneumoniae identified from normally sterile sites between January 1, 2021, and December 31, 2023, in Tāmaki Makaurau Auckland, AoNZ.

Results::

We identified 93 episodes of IPD (annual incidence of 18–40 cases per 100,000 population per year). Serotype was identified in 68 episodes and 46 (68%) were serotype 19A. Incidence was higher in Pacific children compared with non-Māori, non-Pacific children (incidence rate ratio: 2.3; 95% confidence interval: 1.4–3.7). Bacteremia occurred in 65 (70%) episodes, empyema in 47 (51%), meningitis in 11 (12%) and hemolytic uremic syndrome in 7 (7.5%). All cases of hemolytic uremic syndrome and empyema were only among children with serotype 19A. Two children died, both had serotype 19A, and 13/91 survivors (14%) experienced serious sequelae.

Conclusions::

The use of the pneumococcal conjugate vaccine with lower valency and easing of COVID-19 containment measures each may have contributed to an increase in IPD in AoNZ. Serotype 19A is associated with empyema and causes severe disease in young children. Urgent efforts are required to improve PCV13 coverage in AoNZ.

2024-12-31·Expert review of vaccines

PCV15, a pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in infants and children

Review

作者: Lupinacci, Robert ; Dbaibo, Ghassan ; Feemster, Kristen ; Houston, Avril Melissa ; Banniettis, Natalie ; Tamms, Gretchen ; Buchwald, Ulrike K ; Chapman, Timothy J ; Olarte, Liset

INTRODUCTION:

Streptococcus pneumoniae is a causative agent of pneumonia and acute otitis media (AOM), as well as invasive diseases such as meningitis and bacteremia. PCV15 (V114) is a new 15-valent pneumococcal conjugate vaccine (PCV) approved for use in individuals ≥6 weeks of age for the prevention of pneumonia, AOM, and invasive pneumococcal disease.

AREAS COVERED:

This review summarizes the V114 Phase 3 development program leading to approval in infants and children, including pivotal studies, interchangeability and catch-up vaccination studies, and studies in at-risk populations. An integrated safety summary is presented in addition to immunogenicity and concomitant use of V114 with other routine pediatric vaccines.

EXPERT OPINION:

Across the development program, V114 demonstrated a safety profile that is comparable to PCV13 in infants and children. Immunogenicity of V114 is comparable to PCV13 for all shared serotypes except serotype 3, where V114 demonstrated superior immunogenicity. Higher immune responses were demonstrated for V114 serotypes 22F and 33F. Results of the ongoing study to evaluate V114 efficacy against vaccine-type pneumococcal AOM and anticipated real-world evidence studies will support assessment of vaccine effectiveness and impact, with an additional question of whether higher serotype 3 immunogenicity translates to better protection against serotype 3 pneumococcal disease.

210

项与 20价肺炎球菌结合疫苗（辉瑞）相关的新闻（医药）

2024-12-23

·Pharmaceutical Technology

SK bioscience and Sanofi expand agreement for pneumococcal conjugate vaccines

SK bioscience retains exclusive rights in Korea, with Sanofi handling other markets and paying royalties on international sales. Credit: SK bioscience. SK bioscience and Sanofi have expanded their agreement to jointly develop pneumococcal conjugate vaccines (PCVs) targeting both paediatric and adult populations. This partnership extension leverages their ongoing efforts with GBP410, a paediatric vaccine candidate entering Phase III trials. Under the new agreement, Sanofi will make an upfront payment of €50m ($52.1m) to SK bioscience, with additional potential milestones. Research and development expenses will be shared equally, whereas Sanofi will cover all commercialisation expenses. SK bioscience retains exclusive rights in Korea, with Sanofi handling other markets and paying royalties on international sales. Sanofi Vaccines executive vice-president Thomas Triomphe said: “Given the vast unmet public health needs in IPD, we’re delighted to extend this collaboration and continue our pursuit of innovative work in PCV. Our collaboration leverages SK bioscience’s capabilities and Sanofi’s expertise in developing and bringing innovative vaccines to people worldwide with the collective aim of reducing the global impact of pneumococcal disease.” The extended partnership includes the development of PCVs for adult use, aiming to provide comprehensive protection against pneumococcal infections. The initiation of the Phase III clinical programme for GBP410 marks it as the first candidate with over 20 serotypes in this trial phase for infants and toddlers. Phase III studies globally will assess the therapy’s safety and immunogenicity in more than 7,700 subjects who are aged six weeks to 17 years. The trials will involve up to four doses, based on the enrolment age. SK bioscience CEO Jaeyong Ahn said: “Our decision to develop next-generation PCVs and simultaneously initiate phase III clinical programme for GBP410 reflects the GBP410’s high potential for success, a promising market outlook, and our strong mutual trust. “As Korea’s leading company in the vaccine and bio-industry, we are committed to successfully bringing vaccines with blockbuster potential to market that will secure vaccine sovereignty, contribute to global health, and lead the global market.” In preparation for GBP410’s commercialisation, SK bioscience began expanding its ‘L House’ manufacturing facility at Andong, Gyeongsangbuk-do, South Korea in March, with Sanofi’s joint investment. The ground-breaking ceremony for L House took place in March 2024.

疫苗临床3期引进/卖出

2024-12-03

·PipelineReview

Vaxcyte Initiates Phase 2 Study Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease in Infants

— Company Expects to Announce VAX-31 Infant Study Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series in Mid-2026, Followed by Topline Data from the Booster Dose Approximately Nine Months Later — — VAX-31 is Designed to Cover Approximately 94% of Invasive Pneumococcal Disease and Approximately 93% of Acute Otitis Media in U.S. Children Under Five — — VAX-31 Offers Potential to Protect Vulnerable Population by Providing Greater Coverage Against Both Currently Circulating and Historically Prevalent Strains Relative to Standard-Of-Care Pneumococcal Conjugate Vaccines — — Company Remains on Track to Announce VAX-24 Phase 2 Infant Study Topline Data from Primary Immunization Series by End of First Quarter of 2025 — SAN CARLOS, CA, USA I December 03, 2024 I Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced the initiation of the Phase 2 study of VAX-31 in healthy infants and that the first study participants have been dosed. This study is evaluating the safety, tolerability and immunogenicity of VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD). The Company expects to share topline data from the primary three-dose immunization series of the study in mid-2026, followed by topline data from the booster dose approximately nine months later. “The initiation of the VAX-31 Phase 2 infant study marks a significant milestone as we continue advancing our PCV clinical programs, which also include the fully enrolled, ongoing VAX-24 Phase 2 infant study,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “PCVs are vital to combating Streptococcus pneumoniae , a serious public health threat exacerbated by increasing antimicrobial resistance. As the broadest-spectrum PCV candidate in the clinic today, VAX-31 has the potential to expand coverage and provide protection against both currently circulating and historically prevalent serotypes. We look forward to sharing topline data for safety, tolerability and immunogenicity from the VAX-31 Phase 2 infant study’s primary immunization series in mid-2026, and from the booster dose approximately nine months later.” “Despite the effectiveness of current vaccines, Streptococcus pneumoniae is the leading cause of vaccine-preventable deaths globally in children under five and IPD, including meningitis and bacteremia, remains persistent in the first years of life,” said Jim Wassil, Executive Vice President and Chief Operating Officer of Vaxcyte. “It has been clearly signaled by the public health community that a pneumococcal vaccine with a broader spectrum of coverage is needed to provide greater protection against this disease. VAX-31 is designed to cover approximately 94% of IPD and approximately 93% of acute otitis media in U.S. children under five, with the potential to offer much greater coverage relative to the standard-of-care PCVs.” About the VAX-31 Phase 2 Infant Study The VAX-31 Phase 2 infant study is a randomized, double-blind, active controlled, dose-finding, two-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-31 compared to Prevnar 20 (PCV20) in healthy infants. About Pneumococcal Disease Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae bacteria. It can result in invasive pneumococcal disease (IPD), including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis. In the United States, pneumococcal pneumonia is estimated to result in approximately 150,000 hospitalizations each year. Streptococcus pneumoniae is among the World Health Organization’s top antibiotic-resistant pathogens to be urgently addressed, and the U.S. CDC lists drug-resistant Streptococcus pneumoniae as a “serious threat.” In children under five, Streptococcus pneumoniae is the leading cause of vaccine-preventable deaths globally. Pneumococci also cause over 50% of all cases of bacterial meningitis in the United States. Antibiotics are used to treat PD, but some strains of the bacteria have developed resistance to treatments. The morbidity and mortality due to PD are significant, particularly for young children and older adults, underscoring the need for a broader-spectrum vaccine. About VAX-31 VAX-31, a 31-valent PCV candidate advancing to a Phase 3 adult clinical program and currently being evaluated in a Phase 2 infant clinical program, is designed to prevent IPD, which is especially serious in infants, young children, older adults and those with immune deficiencies or certain chronic health conditions. IPD is associated with high case-fatality rates, antibiotic resistance and meningitis. VAX-31 is the broadest-spectrum PCV in the clinic and has the potential to provide protection against both currently circulating and historically prevalent serotypes. VAX-31 was designed to increase coverage, in a single vaccine, to more than 95% of IPD circulating in adults in the United States aged 50 and older, with the potential to provide an incremental 12-40% of coverage over current standard-of-care adult PCVs. In infants, it was designed to cover approximately 94% of IPD and approximately 93% of acute otitis media due to Streptococcus pneumoniae in children under five years of age in the United States. In November 2024, Vaxcyte announced that the FDA granted Breakthrough Therapy designation to VAX-31 for the prevention of IPD in adults. The Breakthrough Therapy designation process is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. About Vaxcyte Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. VAX-31 is a 31-valent, carrier-sparing PCV being developed for the prevention of IPD in adults and infants and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, the Company’s 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market and is currently being evaluated in a Phase 2 infant study. Both VAX-31 and VAX-24 are designed to improve upon the standard-of-care PCVs by covering the serotypes in circulation that are responsible for a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains that are currently contained through continued vaccination practice. Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine candidate designed to prevent Shigella. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com . SOURCE: Vaxcyte

临床2期疫苗突破性疗法临床3期

2024-11-29

·生物制品圈

卷完HPV卷PCV？13价肺炎结合疫苗的困与变

哪些儿童自费疫苗最值得打？无论如何肺炎球菌结合疫苗（国内为13价肺炎结合疫苗，PCV13）恐怕绕不过。PCV13优点很多，但显性缺点也有两个：一是价格贵，足以进入儿童自费疫苗TOP3；二是剂次有点多，基础3针之后还要加强1针让一些家长颇为无奈。 PCV少打1针或2针，有影响吗？近期两大顶刊NEJM和Lancet对于肺炎球菌结合疫苗的减剂次/剂量效果的关注度陡增。NEJM先是发表了一项基于2+1接种程序的PCV10/13价40%的甚至是20%的全剂量的免疫原性与全剂量（正常剂量）的对比研究，结果发现40%剂量的PCV13使用2+1程序的免疫原性非劣效于全剂量的PCV13。而后NEJM又发表了一项针对越南儿童接种PCV10疫苗的减剂量研究，结果显示1+1与2+1及3+0程序的免疫原性相似（非劣效），甚至是0+1程序的免疫原性也达到非劣效于其他三种免疫程序的结果。0+1程序免疫原性虽然理论可行，但可能增加空窗期的患病风险，仅建议考虑在资源匮乏的边远地区使用。除越南外，英格兰、南非这三种截然不同的环境中都验证了1 + 1接种程序的PCV疫苗接种计划可以在拥有成熟PCV计划的国家实施，研究结果陆续发表在柳叶刀子刊上。2015年起英国采用的1+1程序接种PCV13疫苗的大型队列真实世界研究显示，1+1程序非劣效于2+1，可能又将为完全财政模式的英国节约了1剂疫苗费用。无论如何，这些结果可能带来PCV疫苗市场和PCV免疫政策的变革：一方面市场对PCV13的产能需求大大降低，对于WHO将PCV疫苗纳入更多国家或地区的EPI提供了可能。另一方面，精简程序也可能将导致PCV接种率和全程接种率的提高。 PCV疫苗25年程序变迁全球第一款肺炎球菌结合疫苗(PCV7，即7价肺炎多糖结合疫苗) 早在25年前就在美国和欧洲获得了许可，但其上市许可是基于采用3+1接种程序的疗效研究，即在婴儿早期接种三剂，之后在12-15个月之间接种一剂加强剂。此后减少PCV剂次或剂量的想法很快就出现了：加拿大魁北克省和英国分别于2004 年和 2006年率先建议在其国家免疫计划中采用2+1 的PCV接种程序替代原先的3+1方案。尽管美国在2001-2004年期间由于疫苗间歇性短缺而继续使用3+1接种计划，但美国CDC的研究表明，PCV7在使用各种非标准接种计划时都是有效的。魁北克和英国的研究表明，在使用2剂基础免疫程序后，1针加强剂的免疫原性令人满意，预防侵袭性肺炎球菌疾病 (IPD) 的效果也得以保持。这促使欧洲药品管理局 (EMA) 在2008年宣布针对PCV7采用 2+1而非3+1的免疫程序，随后2+1接种程序在欧洲开始流行。 2010年GSK和辉瑞公司开发出了两款含有更多血清型的新疫苗（GSK的PCV10 和辉瑞公司的PCV13），在未开展有效性研究的情况下，许多国家以3+1或2+1的接种程序接种了这些疫苗，有效性研究需要更多的患者才能逐一证明血清型的疗效。 PCV10和PCV13虽然增加了价数，但某些血清型均未达到ELISA IgG临界值平均阈值。正如EMA批准报告所述，在将价数增加到PCV20（辉瑞）的同时，原有血清型的免疫原性也有所降低。目前面临着两种不同的解决方案：第一种是英国继续使用PCV13的1+1接种方案，第二种是EMA最近批准的PCV20采用3+1接种方案。EMA决定启用3+1该接种程序，首先是基于PCV20与PCV13相比对几种血清型的免疫反应较低，其次是在加强剂量之前的一段时间内IPD的理论风险会增加。中国啥时候安排上2+1或1+1？ WHO立场文件当前推荐PCV为2+1程序，我国诸多学者的研究中PCV成为建议优先纳入EPI的重要疫苗，而减少剂次无疑更能降低成本、增加纳入EPI的可能。但时机是否成熟呢？虽然3+1方案中加强剂的真正益处尚不明确，但加强剂是实现群体免疫以及PCV直接和间接疗效的基石，它在减少肺炎球菌鼻咽带菌和提高群体免疫力方面发挥着主要作用。最近在以色列进行的一项研究（2+1程序）证明了这种间接保护作用：7-12月龄婴儿（仅接种2剂）IPD 的减少率（97%）与13-23个月的儿童（98%）相似，后者接种了加强剂。 PCV13对幼儿早期的IPD发病率的影响，得益于全程接种疫苗的儿童在鼻咽带菌中预防了新的疫苗血清型，进而减少了这些血清型在整个人群中的传播。在一个PCV疫苗接种覆盖率较高的国家，大部分避免的IPD病例都是由于疫苗加强剂量的间接效应所致。此外，PCV20的减剂次免疫程序更适用于长期实施国家PCV免疫计划并已建立较高群体免疫水平的国家。采用PCV20的目的是增加对另外七7种血清型的保护，而这7种血清型目前在欧洲基本占主导地位。采用2+1而非3+1接种方案接种PCV20的两难之处在于，如果儿童在接受加强免疫剂量之前接种PCV20的初免剂量较少，则理论上会有较低的个体风险。如果IPD和鼻咽带菌监测系统能在多年内检测到IPD或任何新出现的血清型的早期增加，那么这种风险可能可以接受。然而中国当前的PCV疫苗接种刚进入国产时代不久，接种率还不足以提供确切的群体免疫效应，加强剂次可能仍然有必要，而这也将给EPI的扩容带来困扰，3+1向2+1、1+1甚至0+1方案交叉进行而非过渡中探索。未来随着更多国产厂商入局，提高PCV接种率的步子，尚需要迈的更大一些…… 参考资料： N Engl J Med2024;391:1992-2002. N Engl J Med2024;391:2003-2013. Lancet Infect Dis. 2023 Aug;23(8):933-944. Lancet Child Adolesc Health. 2024 Nov;8(11):774-775. Lancet Infect Dis. 2023 Aug;23(8):884 - 885 Lancet Child Adolesc Health. 2024 Nov;8(11):788-797. Lancet Infect Dis. 2024 Jun;24(6):e356. 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

疫苗临床研究

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
-	-	J07AL	-

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

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
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
流感病毒感染	临床3期	美国	Pfizer Inc.	2020-09-01

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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


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)	憲鑰積繭蓋蓋憲醖憲蓋(製艱夢窪衊製網構衊遞) = 窪鹹遞簾蓋廠繭廠夢遞餘觸鏇鬱壓窪蓋鏇鹽壓 (築壓鬱繭廠構憲廠遞鏇, 鹽範糧構衊積齋衊製夢 ~ 鏇艱製範醖艱醖糧選衊) 更多	-	2024-12-18
				Placebo+BNT162b2+RSVpreF (Group 2: [RSVpreF+BNT162b2] + Placebo)	憲鑰積繭蓋蓋憲醖憲蓋(製艱夢窪衊製網構衊遞) = 鏇壓憲齋醖選選膚衊夢餘觸鏇鬱壓窪蓋鏇鹽壓 (築壓鬱繭廠構憲廠遞鏇, 夢鹽鹽憲網觸齋築遞醖 ~ 鹽憲鬱獵範願憲築鏇鹹) 更多
NCT05875727 (CTgov)	临床3期	肺炎球菌感染	405	Pneumococcal vaccine (Cohort 1: 18 to 49 Years)	繭糧觸遞獵衊夢願鏇鏇(築衊淵網顧憲積蓋獵製) = 構願膚廠夢憲夢鹽鏇構鏇鹽構獵築遞襯築鏇齋 (築獵願範鑰網簾範鑰艱, 糧繭願衊選鏇願糧鬱夢 ~ 範選網築窪夢膚獵壓築) 更多	-	2024-10-24
				Pneumococcal vaccine (Cohort 2: >= 50 Years)	繭糧觸遞獵衊夢願鏇鏇(築衊淵網顧憲積蓋獵製) = 壓淵衊餘選醖鏇淵窪壓鏇鹽構獵築遞襯築鏇齋 (築獵願範鑰網簾範鑰艱, 範膚廠鹽範鏇獵繭積鹽 ~ 積壓蓋艱淵襯醖憲鏇膚) 更多
NCT05408429 (CTgov)	临床3期	肺炎球菌感染	356	20vPnC (2-Dose 20vPnC)	範艱鏇構網遞願積壓製(艱衊鏇蓋膚繭選齋鑰範) = 憲顧積鏇衊顧憲蓋製壓糧餘鑰獵製糧衊範網獵 (構範膚壓鹹觸獵鏇糧憲, 蓋遞壓願鏇夢艱襯鏇遞 ~ 網蓋願製蓋膚鬱衊獵膚) 更多	-	2024-09-19
				20vPnC (1-Dose 20vPnC)	範艱鏇構網遞願積壓製(艱衊鏇蓋膚繭選齋鑰範) = 壓選膚憲選艱窪築醖艱糧餘鑰獵製糧衊範網獵 (構範膚壓鹹觸獵鏇糧憲, 餘積簾鏇艱遞醖鏇淵鹽 ~ 鏇遞齋顧觸築鏇蓋遞願) 更多
NCT04382326 (CTgov)	临床3期	肺炎球菌感染	1,997	20-valent Pneumococcal Conjugate Vaccine (20vPnC) (20vPnC)	襯遞衊鏇膚膚鏇獵鬱築(築遞膚襯繭壓壓鏇獵蓋) = 鑰廠憲鬱選網積齋鑰觸壓餘壓襯願膚築遞鹹鹽 (範窪顧艱積觸鏇醖糧醖, 範繭蓋壓鑰網構鑰鏇壓 ~ 構鏇膚構繭壓憲蓋願築) 更多	-	2023-12-06
				13-valent Pneumococcal Conjugate Vaccine (13vPnC) (13vPnC)	襯遞衊鏇膚膚鏇獵鬱築(築遞膚襯繭壓壓鏇獵蓋) = 鑰鹽鬱蓋構衊齋艱艱觸壓餘壓襯願膚築遞鹹鹽 (範窪顧艱積觸鏇醖糧醖, 鹽鏇構衊築夢鏇艱構夢 ~ 艱蓋齋顧願餘齋選範鏇) 更多
NCT04379713 (CTgov)	临床3期	肺炎球菌感染	1,511	20vPnC (20vPnC)	鹹壓襯製夢繭憲鹹積淵(衊憲艱齋選製築壓構網) = 餘選顧憲觸觸顧製鹹願衊齋製蓋壓鬱觸鹹餘廠 (淵衊壓憲繭網繭積餘選, 齋鹽壓艱鹽鬱憲簾壓築 ~ 願簾窪選醖積網願蓋窪) 更多	-	2023-06-13
				13vPnC (13vPnC)	鹹壓襯製夢繭憲鹹積淵(衊憲艱齋選製築壓構網) = 鹽獵窪蓋範膚築選簾鹹衊齋製蓋壓鬱觸鹹餘廠 (淵衊壓憲繭網繭積餘選, 簾鹹廠窪鹹鬱遞觸鹹獵 ~ 壓襯簾糧範鹹鑰選餘鹹) 更多
NCT04642079 (CTgov)	临床3期	肺炎球菌感染	839	20vPnC+13vPnC (Cohort 1: 20vPnC: >=15 to <24 Months)	憲選鹽簾鏇壓鏇憲鹽醖(獵糧鏇鏇顧壓膚蓋鹽構) = 艱範網築構醖構窪築繭鏇顧衊選醖齋衊積糧衊 (艱窪選構顧選夢繭觸醖, 觸蓋簾繭襯選顧壓獵構 ~ 齋簾襯壓製獵選範鑰鑰) 更多	-	2023-04-26
				20vPnC+13vPnC (Cohort 2: 20vPnC: >=2 to <5 Years)	憲選鹽簾鏇壓鏇憲鹽醖(獵糧鏇鏇顧壓膚蓋鹽構) = 餘襯蓋醖範衊壓鏇顧獵鏇顧衊選醖齋衊積糧衊 (艱窪選構顧選夢繭觸醖, 鹽築衊網艱襯蓋壓鏇範 ~ 顧鏇繭選糧窪簾膚鑰獵) 更多
NCT04530838 (CTgov)	临床3期	肺炎球菌感染	668	20vPnC (20vPnC (SC))	範衊鹹鹽繭蓋夢網網顧(簾憲憲繭壓膚積鏇糧鏇) = 襯餘齋鬱鹹構廠觸鏇齋蓋獵簾齋夢餘構齋鹹鏇 (鏇製廠選壓膚鬱顧糧獵, 襯獵遞憲觸製網獵顧願 ~ 鑰淵遞餘鹽醖糧獵艱積) 更多	-	2023-04-21
				13vPnC (13vPnC (SC))	範衊鹹鹽繭蓋夢網網顧(簾憲憲繭壓膚積鏇糧鏇) = 壓網糧積鏇襯鏇願壓觸蓋獵簾齋夢餘構齋鹹鏇 (鏇製廠選壓膚鬱顧糧獵, 簾壓選蓋範網醖繭繭醖 ~ 顧餘顧築願鹹艱遞淵衊) 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)	遞窪鑰積餘夢遞壓憲鏇(蓋鹹願齋範製艱遞簾顧) = 網鹽餘鏇醖獵餘鏇構壓衊鹽襯齋網鹽積廠繭鏇 (構壓壓鹽鏇鹹糧憲艱淵, 構鏇醖鹽鹽積醖鹽積鑰 ~ 壓鹹襯蓋醖製選壓醖鏇) 更多	-	2022-12-14
				BNT162b2+20vPnC (Coadministration Group (20vPnC+BNT162b2): BNT162b2 Vaccination Site)	遞窪鑰積餘夢遞壓憲鏇(蓋鹹願齋範製艱遞簾顧) = 構繭顧艱壓選齋選選衊衊鹽襯齋網鹽積廠繭鏇 (構壓壓鹽鏇鹹糧憲艱淵, 積觸醖衊糧積範鬱繭鹹 ~ 鹽鑰艱構鏇廠繭糧夢鑰) 更多
NCT04546425 (Corporate Publications) 人工标引	临床3期	肺炎球菌感染	-	20-Valent Pneumococcal Conjugate Vaccine	窪憲夢衊鏇顧願鑰築夢(襯鏇餘網繭膚顧窪蓋構) = 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 憲廠廠願蓋獵願蓋餘願 (鏇製構鬱鏇憲廠築範獵 )	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	餘觸築範鹽淵簾選製鏇(鏇壓積積憲選鏇餘鑰獵) = 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) 繭選糧膚積顧餘窪齋鏇 (遞夢繭壓積糧壓壓衊齋 )	非劣	2022-08-12
				Pneumococcal polysaccharide conjugate vaccine