呼吸道合胞病毒疫苗（辉瑞大药厂）(RSVpreF) - 药物靶点：RSV F protein_在研适应症：呼吸道合胞病毒肺炎，呼吸道合胞体病毒感染，下呼吸道感染_专利_临床

概要

基本信息

药物类型

预防性疫苗

别名

recombinant respiratory syncytial virus pre-fusion F protein, water for injections(Pfizer)、Respiratory Syncytial Virus Vaccine、PF 06928316

+ [4]

靶点

RSV F protein

作用方式

调节剂

作用机制

Respiratory syncytial virus F protein调节剂(呼吸道合胞病毒F蛋白调节剂)

治疗领域

感染呼吸系统疾病

在研适应症

呼吸道合胞病毒肺炎呼吸道合胞体病毒感染下呼吸道感染+ [4]

非在研适应症

流感病毒感染

原研机构

Pfizer Inc.

在研机构

Pfizer Inc.Pfizer Europe MA EEIG

Pfizer Australia Pty Ltd.

+ [1]

非在研机构-

最高研发阶段批准上市

首次获批日期

加拿大 (2023-01-04),

下呼吸道感染

最高研发阶段(中国)临床3期

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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关联

26

项与呼吸道合胞病毒疫苗（辉瑞大药厂）相关的临床试验

NCT06546800

/ Not yet recruitingN/A

SPECIAL INVESTIGATION FOR ABRYSVO INTRAMUSCULAR INJECTION -INVESTIGATION IN INDIVIDUALS AGED 60 YEARS OR OLDER-

This post-marketing study is a multicenter cohort study in individuals aged 60 years or older vaccinated with Abrysvo (RSV vaccine）designed to confirm the safety in individuals aged 60 years or older under actual clinical practice in Japan.

开始日期2025-04-30

申办/合作机构

Pfizer Inc.

NCT06866405

/ Not yet recruiting临床3期

A Phase 3 Study to Investigate the Safety, Tolerability, and Immunogenicity of Revaccinating Pregnant Participants During Subsequent Pregnancies and Persistence of Immunity of a Single Dose of a Bivalent Respiratory Syncytial Virus (RSV) Vaccine.

This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose given during a previous pregnancy by examining the blood of nonpregnant participants who had the vaccine before.

开始日期2025-04-08

申办/合作机构

Pfizer Inc.

NCT06890416

/ Not yet recruiting临床3期

A PHASE 3, MULTICENTER, PARALLEL-GROUP, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE WHEN COADMINISTERED WITH HERPES ZOSTER SUBUNIT VACCINE IN ADULTS ≥50 YEARS OF AGE

This purpose of this phase 3 multicenter, parallel-group, open-label study is to learn about the safety, tolerability, and immunogenicity of RSVpreF and HZ/su vaccine when given together in adults 50 years of age and older.

开始日期2025-04-02

申办/合作机构

Pfizer Inc.

100 项与呼吸道合胞病毒疫苗（辉瑞大药厂）相关的临床结果

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100 项与呼吸道合胞病毒疫苗（辉瑞大药厂）相关的转化医学

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100 项与呼吸道合胞病毒疫苗（辉瑞大药厂）相关的专利（医药）

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124

项与呼吸道合胞病毒疫苗（辉瑞大药厂）相关的文献（医药）

2025-12-31·Expert Review of Vaccines

Cost-effectiveness of bivalent respiratory syncytial virus prefusion F vaccine for prevention of respiratory syncytial virus among older adults in Germany

Article

作者: Lade, Caroline ; Averin, Ahuva ; Huebbe, Bennet ; Sato, Reiko ; Atwood, Mark ; von Eiff, Christof ; Bayer, Lea J

INTRODUCTION:

Among older adults, lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) is common. We evaluated the cost-effectiveness of bivalent RSV prefusion F protein-based vaccine (RSVpreF) for prevention of RSV-LRTI among older adults in Germany.

RESEARCH DESIGN AND METHODS:

A static cohort model was developed to estimate lifetime health and economic outcomes of RSV-LRTI among adults aged 60-99 years in Germany, with (vs. without) use of RSVpreF. Vaccine uptake ranged from 27% to 54%. Vaccine effectiveness was derived from trial data and was assumed to last over 3 years, with some waning, following vaccination. Base case analyses were conducted from the societal perspective (costs/benefits discounted 3% annually); sensitivity analyses also were conducted.

RESULTS:

Among adults aged 60-99 years (N = 25.3 M), RSVpreF prevented 117,360 cases of hospitalized RSV-LRTI, 100,433 cases of ambulatory RSV-LRTI, and 9,298 RSV-LRTI-related deaths over a lifetime horizon. With total overall costs higher by 1.8 € billion and 49,576 quality-adjusted life-years (QALYs) gained, cost-effectiveness of RSVpreF was 36,064 €/QALY. In probabilistic sensitivity analyses, the mean cost-effectiveness ratio was 36,518 €/QALY; 925 of 1,000 replications yielded ratios <50,000 €/QALY.

CONCLUSIONS:

RSVpreF has the potential to greatly reduce the public health and economic burden of RSV among older adults in Germany.

2025-02-01·OBSTETRICS AND GYNECOLOGY

Efficacy, Safety, and Immunogenicity of the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Respiratory Syncytial Virus Prefusion F Protein Vaccine Trial

Article

作者: Simões, Eric A F ; Koury, Kenneth ; Li, Weiqiang ; Polack, Fernando P ; Van Houten, Marlies A ; Baber, James ; Pahud, Barbara A ; Richmond, Peter C ; Gullam, Joanna ; Stein, Renato T ; Adam, Tyler ; Radley, David ; Huang, Li-Min ; Madhi, Shabir A ; Gurtman, Alejandra ; Staerke, Nina B ; Kampmann, Beate ; Tapiero, Bruce ; Lino, Maria Maddalena ; Bont, Louis J ; Barnabas, Shaun L ; Llapur, Conrado ; Swanson, Kena A ; Vargas, Sergio L ; Perreras, Nicole ; Munjal, Iona ; Fausett, Merlin ; Kantele, Anu ; Anderson, Annaliesa S ; Zar, Heather J ; Cooper, David ; Otsuki, Takeo ; Sarwar, Uzma N ; Shittu, Emma ; Kalinina, Elena V ; Padilla, María Duron ; Pérez Marc, Gonzalo ; Baker, Jeffrey

OBJECTIVE::

To evaluate descriptive efficacy data, exploratory immunogenicity data, and safety follow-up through study completion from the global, phase 3 MATISSE (Maternal Immunization Study for Safety and Efficacy) maternal vaccination trial of bivalent respiratory syncytial virus (RSV) prefusion F protein vaccine (RSVpreF).

METHODS::

MATISSE was a phase 3, randomized, double-blinded, placebo-controlled trial. Healthy pregnant participants aged 49 years or younger at 24–36 weeks of gestation were randomized (1:1) to receive a single RSVpreF 120 micrograms or placebo dose. Primary efficacy endpoints included newborn and infant severe RSV-associated medically attended lower respiratory tract illness within 180 days after birth. The RSV-A and RSV-B serum neutralizing antibody titers were determined in a subset of pregnant participants and their newborns.

RESULTS::

In this final analysis, 7,420 pregnant participants were randomized, and 7,307 children were born (RSVpreF n=3,660, placebo n=3,647). Vaccine efficacy, defined as protection against newborn and infant severe RSV-associated medically attended lower respiratory tract illness, was 82.4% (95% CI, 57.5–93.9) and 70.0% (95% CI, 50.6–82.5) within 90 and 180 days of birth, respectively. The RSVpreF induced robust immune responses in pregnant participants and resulted in highly efficient transfer of maternal antibodies to their newborns across subgroups (by gestational age at delivery and at vaccination, number of days from vaccination to delivery, country, maternal age). Final RSVpreF safety results in pregnant and newborn and infant participants were consistent with the primary analysis with no new safety concerns identified.

CONCLUSION::

This final analysis of MATISSE trial data confirms the primary analysis conclusions: Maternal vaccination with RSVpreF has a favorable safety profile in both pregnant and newborn and infant participants and demonstrates efficacy against RSV-associated lower respiratory tract illness in infants through age 6 months. The RSVpreF induces robust immune responses in pregnant individuals, with corresponding high RSV-neutralizing titers in their newborns.

CLINICAL TRIAL REGISTRATION::

ClinicalTrials.gov, NCT04424316.

2025-02-01·NATURE MEDICINE

Impact of RSVpreF vaccination on reducing the burden of respiratory syncytial virus in infants and older adults

Article

作者: Galvani, Alison P ; Singer, Burton H ; Du, Zhanwei ; Moghadas, Seyed M ; Wang, Lin ; Matrajt, Laura ; Pandey, Abhishek ; Bai, Yuan

Abstract:

Respiratory syncytial virus (RSV) causes a substantial health burden among infants and older adults. Prefusion F protein-based vaccines have shown high efficacy against RSV disease in clinical trials, offering promise for mitigating this burden through maternal and older adult immunization. Employing an individual-based model, we evaluated the impact of RSV vaccination on hospitalizations and deaths in 13 high-income countries, assuming that the vaccine does not prevent infection or transmission. Using country-specific vaccine uptake rates for seasonal influenza, we found that vaccination of older adults would prevent hospitalizations by a median of 35–64% across the countries studied here. Vaccination of pregnant women could avert infant hospitalizations by 5–50%. Reductions in RSV-related mortality mirrored those estimated for hospitalizations. While substantial hospitalization costs could be averted, the impact of vaccination depends critically on uptake rates. Enhancing uptake and accessibility is crucial for maximizing the real-world impact of vaccination on reducing RSV burden among vulnerable populations.

636

项与呼吸道合胞病毒疫苗（辉瑞大药厂）相关的新闻（医药）

2025-04-02

·PipelineReview

European Commission Approves Pfizer’s RSV Vaccine ABRYSVO® to Help Protect Adults Aged 18-59 Against RSV Lower Respiratory Tract Disease

NEW YORK, NY, USA I April 01, 2025 I Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has issued a decision amending the marketing authorization for ABRYSVO ® , the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to extend the indication to include prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age. This expands the previous authorization for individuals aged 60 and older, and ABRYSVO now offers in the EU the broadest RSV vaccine indication, which includes: “We are thrilled that ABRYSVO is now approved in the EU to help prevent RSV in adults aged 18 and older, which causes approximately 158,000 adult hospital admissions annually from RSV disease, a common respiratory virus with symptoms that can be severe or even life-threatening,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. “With an indication that also includes pregnant individuals between weeks 24 and 36 gestation to help protect infants from birth up to 6 months of age, ABRYSVO’s expanded authorization for adults aged 18 to 59 in the EU signifies another step for public health by offering the potential to substantially reduce the burden of RSV in future seasons.” The amended marketing authorization follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The authorization is valid in all 27 EU member states plus Iceland, Liechtenstein, and Norway. The approval is based on results from the pivotal phase 3 clinical trial ( NCT05842967 ) MONeT (RSV I M munizati ON Study for Adul T s at Higher Risk of Severe Illness), which investigated the safety, tolerability, and immunogenicity of ABRYSVO in adults 18 through 59 years of age at risk of RSV-associated LRTD due to certain chronic medical conditions. It was also supported by the thousands of persons vaccinated in clinical trials involving ABRYSVO in this age group. 1,2,3,4 The results of MONeT and other studies have been published in peer-reviewed journals. ABOUT RSV Respiratory Syncytial Virus (RSV) is a contagious virus and a common cause of respiratory illness worldwide. 5 The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death. 6,7,8 There are two major subgroups of RSV: RSV-A and RSV-B. 9 Both subgroups cause disease and can co-circulate or alternate predominance from season to season. In total, RSV causes approximately 158,000 hospital admissions annually among adults aged 18 and older across the EU, with an estimated 13,000 hospitalizations in those aged 18 to 64 years. 10 ABOUT ABRYSVO ABRYSVO is an unadjuvanted, bivalent vaccine that was designed to provide protection against RSV-LRTD, regardless of the virus subgroup. In the prefusion state, the RSV fusion protein (F) is a major target of neutralizing antibodies, serving as the basis of Pfizer’s RSV vaccine. Variations in the F protein sequence among RSV-A and RSV-B subgroups are clustered in a key antigenic site, a target for potent neutralizing antibodies. In August 2023, Pfizer announced that the European Commission granted marketing authorization for ABRYSVO for both adults aged 60 years and older and maternal immunization to help protect infants. In the U.S in October 2024, the FDA approved ABRYSVO for the prevention of lower respiratory tract disease caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Prior, in May 2023, the FDA approved ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age and older. In August 2023, the FDA approved ABRYSVO for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to 6 months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. In addition to the most recent EU approval, ABRYSVO has received approvals for both indications in multiple countries worldwide. U.S. INDICATIONS FOR ABRYSVO ABRYSVO ® is a vaccine indicated in the U.S. for: View the full ABRYSVO Prescribing Information . About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments, and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News , LinkedIn , YouTube , and like us on Facebook at Facebook.com/Pfizer . 1 Walsh EE, Falsey AR, Scott DA, et al. A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine. J Infect Dis. 2022 Apr 19;225(8):1357-1366. 2 Schmoele-Thoma B, Zareba AM, Jiang Q, et al. Vaccine Efficacy in Adults in a Respiratory Syncytial Virus Challenge Study. N Engl J Med. 2022 Jun 23;386(25):2377-2386. doi: 10.1056/NEJMoa2116154. 3 Baker J, Aliabadi N, Munjal I, et al. Equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age: Results of a randomized phase 3 study. Vaccine. 2024 May 10;42(13):3172-3179. doi: 10.1016/j.vaccine.2024.03.070. Epub 2024 Apr 16. 4 Peterson JT, Zareba AM, Fitz-Patrick D, et al. Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F Vaccine When Coadministered With a Tetanus, Diphtheria, and Acellular Pertussis Vaccine. J Infect Dis. 2022 Jun 15;225(12):2077-2086. doi: 10.1093/infdis/jiab505. 5 World Health Organization. Respiratory Syncytial Virus (RSV) disease. https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/vaccine-standardization/respiratory-syncytial-virus-disease 6 World Health Organization. Respiratory Syncytial Virus (RSV). https://www.who.int/news-room/fact-sheets/detail/respiratory-syncytial-virus-(rsv) 7 Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV) – Older Adults are at High Risk for Severe RSV Infection Fact Sheet. https://www.cdc.gov/rsv/factsheet-older-adults.pdf 8 Centers for Disease Control and Prevention. RSV in Infants and Young Children. https://www.cdc.gov/rsv/high-risk/infants-young-children.html 9 Nuttens C, Moyersoen J, Curcio D, et al. Differences Between RSV A and RSV B Subgroups and Implications for Pharmaceutical Preventive Measures. Infect Dis Ther . 2024;13(8):1725-1742. doi:10.1007/s40121-024-01012-2 10 Del Riccio M, Spreeuwenberg P, Osei-Yeboah R, et al. Estimation of the Number of Respiratory Syncytial Virus–Associated Hospitalizations in Adults in the European Union. J Infect Dis 2023 May 29;228(11):1539–1548. doi: 10.1093/infdis/jiad189 . SOURCE: Pfizer

上市批准临床3期疫苗临床结果

2025-04-02

·GBIHealth

国家卫健委：做好2025年基层卫生健康综合试验区重点工作

药械追踪No.1 / 辉瑞RSV疫苗获欧盟批准扩大适应证至18-59岁人群2025年4月2日，辉瑞（NYSE:PFE）宣布，呼吸道合胞病毒（RSV）疫苗Abrysvo已获欧盟委员会（EC）批准扩展适应证，将针对60岁及以上人群的适应证扩展至包括预防18至59岁人群因RSV导致的下呼吸道疾病（LRTD）。关键性III期临床试验（NCT05842967）MoNeT的积极结果支持了此次扩展适应证的批准。Abrysvo是一款无佐剂二价疫苗，目前在欧盟拥有最广泛的RSV疫苗适应证，具体包括：为18岁及以上人群提供主动免疫，预防由RSV引起的LRTD；为孕期24至36周的孕妇接种，为出生后至6个月内的婴儿提供针对RSV引起的LRTD的被动保护。->点击文末阅读原文，解锁完整双语新闻No.2 / 华东医药司美格鲁肽生物类似药上市申请获NMPA受理2025年4月2日，华东医药（000963.SZ）发布公告称，子公司江东公司的司美格鲁肽注射液上市申请获国家药监局受理，用于成人2型糖尿病患者的血糖控制。司美格鲁肽注射液是一种长效胰高血糖素样肽-1（GLP-1）受体激动剂，与人GLP-1有94%的序列同源性，临床上主要用于2型糖尿病患者的血糖控制、肥胖或超重患者的长期体重管理。司美格鲁肽注射液的原研企业为诺和诺德，目前国内仅有诺和诺德的司美格鲁肽获批上市。其他还有齐鲁制药、九源基因、丽珠集团在国内提交司美格鲁肽上市申请。->点击文末阅读原文，解锁完整双语新闻企业动态No.1 / 欧加隆收购百奥泰托珠单抗生物类似药静脉注射剂美国商业化权益2025年4月1日，百奥泰生物制药股份有限公司（688177.SH）宣布，欧加隆自渤健收购了百奥泰托珠单抗生物类似药TOFIDENCE的美国商业化权益。此前，百奥泰曾于2021年4月将TOFIDENCE在除中国地区（包括中国大陆及港澳台）以外的全球市场的独占的产品权益许可给渤健。后续欧加隆将负责TOFIDENCE在美国的市场和销售等相关商业化活动，百奥泰将负责TOFIDENCE的生产和商业化供应。欧加隆将承担渤健在2021年的授权协议中基于净销售额和年度净销售额向百奥泰支付分级特许权使用费和里程碑付款的义务。TOFIDENCE于2024年5月获FDA批准，是美国市场首个获批的托珠单抗生物类似药。其适用于治疗中度至重度活动性类风湿性关节炎、巨细胞动脉炎、多关节幼年特发性关节炎、系统性幼年特发性关节炎、COVID-19感染等适应证。->点击文末阅读原文，解锁完整双语新闻行业政策No.1 / 国家卫健委：做好2025年基层卫生健康综合试验区重点工作2025年4月1日，国家卫生健康委办公厅发布关于做好2025年基层卫生健康综合试验区重点工作的通知，要求地方各级卫生健康行政部门指导试验区深入学习三明医改经验和基层卫生健康综合试验区首批改革创新典型经验，促进“三医”协同发展和治理，深化体制机制改革，推动分级诊疗体系建设。国家和省级试验区要率先高标准落实基层卫生健康年度重点工作：①加强县域医疗卫生服务体系和基层医疗卫生服务能力建设，2025年底前实现乡镇卫生院和社区卫生服务中心县级医院人员派驻全覆盖、提供儿童常见疾病诊疗服务全覆盖。②积极开展家庭医生“签约有感”行动，推行签约个性化服务包并落实签约费用，签约覆盖率比上年度提高1-3个百分点。③优化慢性病患者连续服务，推动慢性病、肥胖症等膳食、运动指导要点嵌入基层医疗服务。国家试验区要主动改革创新，发挥示范引领作用：①完善医保支持分级诊疗政策和县域医共体人员下沉长效保障机制，优化绩效分配方案。②探索将签约居民的医保门诊统筹基金按人头支付给家庭医生（团队），合理测算签约服务费结算标准，将不低于70%的签约服务费用于签约服务人员薪酬。③全面推动存量乡村医生“乡聘村用”，加快乡村医生向执业（助理）医师转变，提高村卫生室运行补助和乡村医生岗位补助。④2025年每个试验区培养医防管复合型人才人数不少于30人。⑤推动建立营养评估与营养指导、运动评估与运动指导等服务收费机制。⑥发挥村（居）民委员会公共卫生委员会作用，将基层卫生健康工作融入村（社区）网格，促进社会共治。->点击阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ xujingou@baidu.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

并购临床3期生物类似药上市批准疫苗

2025-04-01

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辉瑞RSV疫苗在欧盟适应症扩大至18岁及以上人群

4月1日，辉瑞宣布欧洲委员会（EC）已批准其二价呼吸道合胞病毒（RSV）疫苗Abrysvo的新适应症申请，扩展至预防18至59岁人群由RSV引起的下呼吸道疾病（LRTD）。这一批准进一步扩大了原有针对60岁及以上人群的适应症，使Abrysvo成为欧盟目前覆盖范围最广的RSV疫苗，具体适应症包括：对18岁及以上的人群进行主动免疫接种，预防RSV引起的LRTD。通过孕妇在孕期接种，为出生至6个月婴儿提供被动保护，预防RSV引起的LRTD。Abrysvo是一种无佐剂二价疫苗，旨在预防RSV-A和RSV-B亚群引起的下呼吸道疾病。在融合前状态下，F蛋白（preF）是中和抗体的主要靶点，Abrysvo通过靶向F蛋白关键抗原位点，可有效应对不同亚群的序列变异。此次审批基于欧洲药品管理局人用药品委员会（CHMP）近期的积极意见，批准范围覆盖欧盟27个成员国及冰岛、列支敦士登和挪威。审批依据包括关键III期MONeT研究（NCT05842967）的结果。辉瑞首席国际商务官、执行副总裁Alexandre de Germay表示："我们非常高兴Abrysvo在欧盟获批用于帮助预防18岁及以上成人RSV感染。这种常见呼吸道病毒每年在欧盟导致约15.8万例成人住院，症状可能严重甚至危及生命。通过将适应症扩展至18-59岁人群，并保留对孕期24-36周孕妇接种以保护婴儿的适应症，Abrysvo的获批标志着公共卫生领域的又一重要进展，有望大幅减轻未来季节RSV的疾病负担。"2024年10月，美国FDA最早批准Abrysvo用于18-59岁高风险人群预防RSV引起的LRTD。在美国和欧盟，GSK的RSV疫苗Arexvy适用范围也由最初的60岁及以上人群扩大至50-59岁的RSV高危成人。Copyright © 2025 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

疫苗临床3期

100 项与呼吸道合胞病毒疫苗（辉瑞大药厂）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,

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适应症	国家/地区	公司	日期
呼吸道合胞病毒肺炎	欧盟	Pfizer Europe MA EEIG	2023-08-23
呼吸道合胞病毒肺炎	冰岛	Pfizer Europe MA EEIG	2023-08-23
呼吸道合胞病毒肺炎	列支敦士登	Pfizer Europe MA EEIG	2023-08-23
呼吸道合胞病毒肺炎	挪威	Pfizer Europe MA EEIG	2023-08-23
呼吸道合胞体病毒感染	美国	Pfizer Inc.	2023-05-31
下呼吸道感染	加拿大	Pfizer Canada ULC	2023-01-04

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
带状疱疹	临床3期	美国	Pfizer Inc.	2025-04-02
带状疱疹	临床3期	波多黎各	Pfizer Inc.	2025-04-02
流感病毒感染	临床3期	澳大利亚	Pfizer Inc.	2022-04-13
呼吸道感染	临床3期	美国	Pfizer Inc.	2020-06-17
呼吸道感染	临床3期	日本	Pfizer Inc.	2020-06-17
呼吸道感染	临床3期	阿根廷	Pfizer Inc.	2020-06-17
呼吸道感染	临床3期	澳大利亚	Pfizer Inc.	2020-06-17
呼吸道感染	临床3期	巴西	Pfizer Inc.	2020-06-17
呼吸道感染	临床3期	加拿大	Pfizer Inc.	2020-06-17
呼吸道感染	临床3期	智利	Pfizer Inc.	2020-06-17

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临床结果

适应症

分期

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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)	鬱築顧鏇鬱襯膚廠選膚 = 醖淵遞範網蓋觸夢鑰醖繭選醖顧膚築齋獵願廠 (願廠淵糧蓋鹹襯願簾鬱, 醖築鹽蓋獵壓遞艱鹽鹽 ~ 繭鑰繭窪鏇餘繭鏇艱鬱) 更多	-	2025-03-25
				Placebo+BNT162b2+RSVpreF (Group 2: [RSVpreF+BNT162b2] + Placebo)	鬱築顧鏇鬱襯膚廠選膚 = 窪選醖淵醖網簾齋遞築繭選醖顧膚築齋獵願廠 (願廠淵糧蓋鹹襯願簾鬱, 簾獵憲積蓋範獵壓衊糧 ~ 衊願醖範願獵鏇艱淵鬱) 更多
NCT05788237 (CTgov)	临床1期	流感病毒感染	508	RSVpreF+qIRV (SSA: Group 1: RSVpreF + qIRV)	壓餘蓋鬱積餘積鬱顧構 = 糧積鬱鹽構膚範壓構鹽夢艱遞憲蓋顧觸鑰壓廠 (壓顧廠顧蓋醖鏇襯遞艱, 憲製鹹構獵積鹽夢鏇網 ~ 鏇鏇構簾觸網醖鹽淵簾) 更多	-	2024-11-22
				qIRV (SSA: Group 2: qIRV)	壓餘蓋鬱積餘積鬱顧構 = 網積構選獵鹹襯艱積醖夢艱遞憲蓋顧觸鑰壓廠 (壓顧廠顧蓋醖鏇襯遞艱, 選窪夢製鏇窪築醖範築 ~ 鏇遞蓋廠窪醖觸觸網積) 更多
NCT05842967 (MONeT, PipelineReview) 人工标引	临床3期	呼吸道合胞体病毒感染	203	ABRYSVO	積壓廠糧簾鹽餘淵鹹夢(夢選顧獵鬱製齋淵網糧) = ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other studies of the vaccine. 膚遞蓋鏇衊觸醖獵顧鑰 (襯簾範繭鏇鑰範餘願築 ) 更多	积极	2024-08-12
NCT04785612 (Phase 2a study, CTgov)	临床2期	呼吸道合胞体病毒感染	70	RSVPreF (RSVPreF)	獵淵淵獵製鹽築網蓋選(築襯淵獵襯鬱鬱衊築築) = 構廠簾製獵膚廠膚願醖壓艱範鹽獵網蓋蓋製範 (築鹹糧鏇廠憲壓醖願選, 遞積夢鹹壓衊顧顧選鬱 ~ 夢壓積糧蓋構鬱廠製鏇) 更多	-	2024-08-07
				Placebo (Placebo)	獵淵淵獵製鹽築網蓋選(築襯淵獵襯鬱鬱衊築築) = 網鑰鏇蓋築糧襯淵網獵壓艱範鹽獵網蓋蓋製範 (築鹹糧鏇廠憲壓醖願選, 願構醖窪憲夢窪願遞顧 ~ 蓋繭選網醖選鑰糧廠艱) 更多
NCT04424316 (MATISSE, Pubmed)	临床3期	呼吸道合胞体病毒感染	-	RSVpreF vaccine	範築鏇憲簾膚鑰餘淵齋(獵願觸鹹願鏇艱遞遞積) = 廠齋壓顧遞糧淵築築憲糧蓋願範壓範蓋夢鏇範 (醖鏇遞願艱鏇襯夢鹽淵 ) 更多	积极	2024-06-08
				bivalent RSVpreF maternal vaccination (Placebo)	範築鏇憲簾膚鑰餘淵齋(獵願觸鹹願鏇艱遞遞積) = 衊簾壓遞構築製壓積積糧蓋願範壓範蓋夢鏇範 (醖鏇遞願艱鏇襯夢鹽淵 ) 更多
NCT05842967 (MONeT, Corporate Publications) 人工标引	临床3期	慢性阻塞性肺疾病 \| 哮喘 \| 糖尿病 ... 更多	-	ABRYSVO	蓋餘廠繭廠壓築廠鑰遞(願膚艱膚齋艱齋鬱構網) = Participants demonstrated RSV-A and RSV-B subgroup neutralizing responses non-inferior to the response seen in the Phase 3 (NCT05035212) RENOIR study of ABRYSVO in more than 34,000 adults aged 60 or older where vaccine efficacy was previously demonstrated. 鏇衊製獵襯淵襯繭蓋鹹 (鏇鬱憲遞鹹鬱範鏇憲構 ) 达到更多	积极	2024-04-09
NCT05035212 (RENOIR, Biospace) 人工标引	临床3期	呼吸道合胞体病毒感染	-	ABRYSVO (three or more symptoms)	範繭鏇襯繭製齋淵餘鑰(網繭範網淵廠憲簾鹽選) = 鑰壓範窪壓獵願顧艱製選範願獵鹽製簾願鬱衊 (齋範齋鑰衊鑰夢襯壓夢, 51.4 ~ 91.1) 更多	积极	2024-03-29
				ABRYSVO (two or more symptoms)	範繭鏇襯繭製齋淵餘鑰(網繭範網淵廠憲簾鹽選) = 蓋範鑰糧遞鏇網膚繭襯選範願獵鹽製簾願鬱衊 (齋範齋鑰衊鑰夢襯壓夢, 34.7 ~ 70.4) 更多
NCT05035212 (RENOIR, NEWS) 人工标引	N/A	呼吸道合胞体病毒感染	-	Abrysvo (older adults with two or more symptoms of RSV)	鏇夢積繭艱壓範衊窪觸(選積鏇膚艱糧鬱積鑰夢) = 憲構夢積夢廠窪壓夢網餘蓋窪衊繭觸選鹽醖遞 (積衊醖廠範網繭餘積膚 )	积极	2023-11-29
				Abrysvo (older adults with two or more symptoms)	鏇夢積繭艱壓範衊窪觸(選積鏇膚艱糧鬱積鑰夢) = 築艱醖膚選餘網憲夢觸餘蓋窪衊繭觸選鹽醖遞 (積衊醖廠範網繭餘積膚 )
NCT04424316 (MATISSE, NEWS) 人工标引	N/A	呼吸道合胞体病毒感染	-	Abrysvo (first 90 days after birth)	鹹網積願淵憲簾製觸築(憲夢願範顧範築獵廠膚) = 廠構願淵蓋繭憲選壓鹽廠醖鹹願鹽餘顧鑰餘憲 (選壓夢鹽衊選衊網醖壓 )	积极	2023-11-29
				Abrysvo (within 180 days)	鹹網積願淵憲簾製觸築(憲夢願範顧範築獵廠膚) = 廠簾積製顧夢餘鹽廠膚廠醖鹹願鹽餘顧鑰餘憲 (選壓夢鹽衊選衊網醖壓 )
NCT05301322 (CTgov)	临床3期	呼吸道合胞体病毒感染 \| 流感病毒感染	1,471	SIIV+RSVpreF (RSVpreF + SIIV: Coadministration Group)	選鏇築醖醖襯壓鏇獵築 = 積壓構構淵襯鏇願鑰築獵鑰鬱夢淵網網壓鏇遞 (醖壓鏇顧製構鬱網餘獵, 網憲選艱壓鑰憲鬱膚鹹 ~ 鹽襯糧積構網遞蓋繭憲) 更多	-	2023-10-27
				Placebo (Placebo: Coadministration Group)	選鏇築醖醖襯壓鏇獵築 = 夢鏇淵築製鬱膚鹹鏇窪獵鑰鬱夢淵網網壓鏇遞 (醖壓鏇顧製構鬱網餘獵, 製廠鏇襯鹹壓餘憲獵廠 ~ 壓繭壓齋鹹蓋網願艱範) 更多