重组呼吸道合胞病毒疫苗（GSK）(Respiratory Syncytial Virus Vaccine (GSK)) - 在研适应症：呼吸道合胞体病毒感染，新型冠状病毒感染_专利_临床

概要

基本信息

药物类型

预防性疫苗

别名

RSV vaccine、RSVPreF3 OA、RSVPreF3 OA investigational vaccine

+ [11]

靶点-

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病

在研适应症

呼吸道合胞体病毒感染新型冠状病毒感染

非在研适应症-

原研机构

GSK Plc

在研机构

GlaxoSmithKline, Inc.

GSK PlcGlaxoSmithKline Biologicals SA

+ [2]

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (2023-05-03),

呼吸道合胞体病毒感染

最高研发阶段(中国)临床3期

特殊审评优先审评 (美国)

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关联

30

项与重组呼吸道合胞病毒疫苗（GSK）相关的临床试验

CTR20243122 / Recruiting临床3期

一项在60岁及以上成人中评价GSK RSVPreF3 OA试验用疫苗单剂接种的免疫原性、反应原性、安全性和RSV相关呼吸道疾病发生情况的III期、随机、对照、部分设盲、免疫桥接研究

主要目的：证明入组中国RSV老年人（OA）组的中国OA接种RSVPreF3 OA试验用疫苗后对A型和B型RSV的体液免疫应答非劣效（NI）于入组境外RSV OA组的OA。次要目的：评价截至接种后6个月入组中国RSV OA组的中国OA的体液免疫应答并与入组境外RSV OA组的OA进行比较。评价中国RSV OA组的体液免疫应答并与全球保护效力研究RSV OA=ADJ-006的免疫原性亚组的历史数据进行比较。描述中国RSV OA组和中国安慰剂组中的RSV确诊的急性呼吸道疾病（ARI）和RSV确诊的下呼吸道疾病（LRTD）。评估试验用RSVPreF3 OA疫苗接种后的安全性和反应原性。

开始日期2024-11-13

申办/合作机构

GlaxoSmithKline Biologicals SAS

[+2]

CTRI/2024/09/073941 / Recruiting临床3期

A Phase 3 randomized, placebo-controlled observer blindstudy in India to evaluate immune responsereactogenicity and safety of a single intramusculardose of RSVPreF3 OA investigational vaccine whenadministered to older adults =60 years of age andadults 50-59 years of age at increased risk ofrespiratory syncytial virus lower respiratory tractdisease. - NIL

开始日期2024-10-01

申办/合作机构

GlaxoSmithKline Biologicals SA

NCT06593210 / Recruiting临床3期IIT

Safety and Immunogenicity of Non-live, Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine in Allogeneic Stem Cell Transplant and Lung Transplant Recipients

Adjuvant, non-live RSV vaccine will be administered to adult lung and allogeneic hematopoietic stem cell transplant recipients. The safety and immunogenicity of this intervention will be studied. Blood work will be collected before and after the intervention, to assess humoral and cellular immunity. Participants will be followed for adverse reaction, hospitalization, RSV breakthrough infection, graft rejection or graft versus host disease. This study has Health Canada and UHN REB approval.

开始日期2024-10-01

申办/合作机构

University Health Network

100 项与重组呼吸道合胞病毒疫苗（GSK）相关的临床结果

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100 项与重组呼吸道合胞病毒疫苗（GSK）相关的转化医学

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100 项与重组呼吸道合胞病毒疫苗（GSK）相关的专利（医药）

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43

项与重组呼吸道合胞病毒疫苗（GSK）相关的文献（医药）

2024-12-31·Expert Review of Vaccines

Cost-effectiveness analysis of respiratory syncytial virus vaccination with the adjuvanted prefusion F protein vaccine (RSVPreF3 OA) for adults ≥60 years old in Japan

Article

作者: Matsuki, Taizo ; Verelst, Frederik ; Ho, Yufan ; Mizukami, Akiko ; Molnar, Daniel ; Kurai, Daisuke ; Preckler, Victor

OBJECTIVESOlder adults (OA) are at risk of morbidity and mortality from respiratory syncytial virus (RSV), a major cause of seasonal acute respiratory illness. The first RSV vaccine for OA (RSVPreF3 OA) was recently launched in Japan. With the already large and growing OA population in Japan, and limited RSV treatments, prevention is key. The aim of this study was to assess the cost-effectiveness of introducing RSVPreF3 OA for Japanese adults aged ≥60 years.METHODSA static multicohort Markov model was adapted to assess the cost-effectiveness of a single dose of RSVPreF3 OA versus no vaccination over a three-year time horizon. Deterministic and probabilistic sensitivity analyses were conducted to assess parameter uncertainty.RESULTSRSVPreF3 OA vaccination prevented 1,008,499 cases and 6,840 deaths, with 109,119 quality-adjusted life-years (QALYs) gained. The incremental cost-effectiveness ratio was Japanese yen (JPY) 4,180,084/QALY gained from a payer perspective and JPY 4,041,917/QALY gained from a societal perspective (with productivity loss from RSV disease), thus vaccination was considered cost-effective. Base case results were robust to changes in sensitivity and scenario analyses.CONCLUSIONSRSVPreF3 OA vaccination for adults ≥60 years can provide substantial health benefits and is a cost-effective intervention to reduce the RSV burden in Japan.

2024-12-31·Expert Review of Vaccines

The potential public health impact of the respiratory syncytial virus prefusion F protein vaccine in people aged ≥60 years in Japan: results of a Markov model analysis

Article

作者: Ho, Yufan ; Kurai, Daisuke ; Preckler, Victor ; Matsuki, Taizo ; Molnar, Daniel ; Mizukami, Akiko ; Igarashi, Ataru ; Verelst, Frederik

BACKGROUNDRespiratory syncytial virus (RSV), a common respiratory pathogen, can lead to severe symptoms, especially in older adults (OA). A recently developed RSV prefusion F protein (RSVPreF3 OA) vaccine confers high protection against RSV lower respiratory tract disease (LRTD) over two full RSV seasons. The aim of this study was to assess the potential public health impact of RSVPreF3 OA vaccination in the Japanese OA population.RESEARCH DESIGN AND METHODSA static Markov model was used to estimate the number of symptomatic RSV cases, hospitalizations and deaths in the Japanese population aged ≥ 60 years over a 3-year time horizon. Japan-specific RSV epidemiology and healthcare resource use parameters were used; vaccine efficacy was derived from a phase 3 randomized study (AReSVi-006, NCT04886596). Vaccination coverage was set to 50%.RESULTSWithout vaccination, >5 million RSV acute respiratory illness (ARI) would occur (2.5 million LRTD and 2.8 million upper respiratory tract infections) leading to ~ 3.5 million outpatient visits, >534,000 hospitalizations and ~ 25,500 RSV-related deaths over 3 years. Vaccination could prevent > 1 million RSV-ARI cases, 728,000 outpatient visits, 143,000 hospitalizations and 6,840 RSV-related deaths.CONCLUSIONSRSVPreF3 OA vaccination is projected to have a substantial public health impact by reducing RSV-related morbidity and mortality in the OA population.

2024-11-01·Die Innere Medizin

Impfung gegen das respiratorische Synzytialvirus (RSV) – zum Schutz von Säuglingen und älteren Erwachsenen

Review

作者: Pley, Caitlin ; Kampmann, Beate

Respiratory syncytial virus (RSV) is a frequent cause of respiratory infections in all age groups. Infections in infants and older adults frequently result in severe disease and complications. There is no specific antiviral treatment against RSV. The characterization of the structure of the fusion (F) protein in its immunogenic prefusion conformation has enabled the development of novel vaccines directed against the prefusion protein as the antigen. These include an adjuvanted monovalent vaccine (Arexvy) and a nonadjuvanted bivalent vaccine (Abrysvo). Both are approved and indicated for use in older adults, in whom they have been shown to be over 80% effective in the protection against symptomatic RSV infections and associated lower respiratory tract diseases. Abrysvo is approved for use in pregnancy to protect the newborn through the transplacental transfer of high-titer maternal antibodies. The vaccine has been shown to have an efficacy of over 80% in the first 3 months of life to protect the infant from severe RSV-associated lower respiratory disease but slightly deceases after an age of 6 months. The clinical studies demonstrated the safety of the vaccines in both adults and pregnant women. The rate of undesired side effects was low in all studies and severe side effects were very rare. The new vaccines are efficacious new tools to prevent RSV-associated disease and complications in high-risk groups. For infants, an alternative strategy can be passive immunization with monoclonal antibodies, including the recently developed nirsevimab, which has also shown high efficacy.

470

项与重组呼吸道合胞病毒疫苗（GSK）相关的新闻（医药）

2024-11-14

·生物制品圈

深信生物二价RSV mRNA疫苗IN006启动Ⅰ期临床试验并完成首例受试者给药

2024年11月13日，香港、深圳、南京、波士顿——深信生物（Innorna），一家专注于脂质纳米颗粒（LNP）递送技术及创新RNA疗法开发的临床阶段生物制药公司，宣布其自主研发的二价呼吸道合胞病毒（RSV）mRNA疫苗IN006在中国正式启动Ⅰ期临床试验，并完成了首例受试者给药。本次临床试验是一项在18周岁及以上健康人群中开展的随机、双盲、安慰剂对照研究，旨在评价IN006在前述人群接种后的安全性、耐受性和免疫原性。 IN006分别于2024年1月和6月获得美国食品药品监督管理局（FDA）的IND批准和中国国家药品监督管理局药品审评中心（CDE）的临床试验默示许可，是首款获得中国临床试验许可的国产RSV疫苗产品，亦是全球首款进入临床开发的二价RSV mRNA疫苗。本次首例受试者给药标志着IN006达成又一个重要里程碑，成为首款在中国正式启动临床试验的国产RSV疫苗产品。关于呼吸道合胞病毒（RSV）和IN006 RSV是一种具有高度传染性的呼吸道病毒，可在人群中引起反复感染。普通人群RSV感染表现与普通感冒无异，但老年人、婴幼儿及免疫缺陷人群RSV感染可导致严重的下呼吸道疾病，从而造成巨大的疾病和社会负担。2019年全球5岁以下儿童中发生3,300万例RSV感染导致的急性下呼吸道感染，360万例患儿因此住院治疗，其中10.1万例患儿死亡。老年人因RSV相关感染而住院者的重症监护率和死亡率，甚至2~3倍于流感病毒感染或新型冠状病毒感染。RSV感染可在社区和医院环境中引起暴发流行，现有的临床治疗手段主要为支持治疗和对症治疗，而缺乏特效抗病毒治疗方案。接种预防性疫苗进行主动免疫，是避免RSV重症感染和减少死亡的关键措施。经过数十年的研发探索，目前全球共有三款RSV疫苗获批上市，分别为GSK和Pfizer的重组蛋白（亚单位）疫苗AREXVY（单价）和ABRYSVO（二价），以及Moderna的mRNA疫苗 mRESVIA（单价）。目前，中国尚无RSV疫苗产品获批上市。 IN006采用了深信生物拥有自主知识产权的融合前F蛋白设计、mRNA元件和LNP递送系统。IN006含有分别编码RSV-A和RSV-B稳定融合前构象F蛋白的mRNA，是同时针对RSV-A和RSV-B两个亚组的二价mRNA疫苗。RSV-A和RSV-B病毒在不同流行季通常交替或同时流行，尽管单价RSV疫苗通常具有针对RSV-A和RSV-B的交叉保护效果，但二价RSV疫苗可能具有更好的广谱性。临床前研究显示IN006安全性良好，具备突出的体液免疫及细胞免疫激活能力，并在攻毒试验中显示出对RSV-A和RSV-B均具有良好的攻毒保护效果。关于深信生物深信生物成立于2019年，致力于开发全球领先的LNP递送技术平台及创新RNA疗法，以解决尚未满足的临床需求。深信生物目前已建立了一个包含5000多种可离子化脂质的多样性导向LNP库（DOLL），可应用于多种创新疗法的开发，包括mRNA疫苗和药物、在体基因编辑疗法和细胞疗法等。基于其专有的mRNA和LNP技术平台，深信生物已在传染病疫苗、罕见病及肿瘤免疫领域布局了多个内部研发管线，同时与国内外多家生物制药企业建立了合作，以探索该技术在更广泛治疗领域的开发潜力。自成立以来，深信生物获得了投资界和工业界的广泛认可，荣获了MIT科技评论全球50家聪明公司、《财富》中国最具社会影响力创业公司等数十个奖项。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。

信使RNA疫苗临床2期临床1期上市批准

2024-11-08

·CPHI制药在线

从2024“进博宝宝”看全球创新药研发趋势

关注并星标CPHI制药在线 11月5日，第七届中国国际进口博览会(下称“进博会”) 在上海开幕。作为世界上首个以进口为主题的国家级展会，进博会从2018年以来已连续举办七届，已经成为全球企业展示创新成果、加强国际经贸合作的关键舞台。药品板块作为本届进博会最引人注目的展区之一，吸引了全球医药巨头参展，展示了创新药研发、生物医药技术等医药领域新质生产力。本届进博会有哪些具有代表性的“进博宝宝”（通过进博会实现在中国落地投入使用的产品）创新药参展？其背后揭示了怎样的研发趋势？MNC对中国市场的态度发生了什么变化？爆款创新药，跑步进入中国市场本次进博会上，以罗氏、辉瑞、诺和诺德、吉利德等为代表的MNC，带来了各自的医药医疗创新产品，不少是全球首发或全球尚未获批上市的产品。罗氏带来了30多款已上市和即将在中国上市的创新药，其中包括中国首个且唯一的磷脂酰肌醇3-激酶（PI3K）α抑制剂伊那利塞（Inavolisib），2024年10月，FDA批准伊那利塞联合哌柏西利和氟维司群用于治疗在辅助内分泌治疗期间或完成后复发后的内分泌治疗耐药、PIK3CA突变的激素受体阳性（HR+）、人表皮生长因子受体2阴性（HER2-）的局部晚期或转移性乳腺癌成人患者。此前，罗氏曾于2024年6月同步向中、美申报上市。作为一款高选择性PI3Kα抑制剂，伊那利塞对PI3Kα的选择性和效力均高于其它亚型（PI3Kβ/δ/γ)），并且能够特异性触发突变PI3Kα蛋白的降解。基于这种独特的双重作用机制，伊那利塞可能为HR+/HER2-的PI3Kα突变型晚期乳腺癌患者提供耐受性良好、持久的疾病控制效果。在伊那利塞之前，全球仅有诺华的阿吡利塞这一款PI3Kα抑制剂获批上市，其余PI3Kα抑制剂产品尚属于研发阶段。本次罗氏展出伊那利塞，有望借进博会的溢出效应加速其获批上市。辉瑞今年带来了24款创新产品，其中有4款产品在中国首次展出，分别是全球首个针对金属β-内酰胺酶（MBLs）的β-内酰胺类/β-内酰胺酶抑制剂组合——思福诺（注射用氨曲南阿维巴坦钠）、前列腺癌领域的新型双重机制PARP抑制剂——甲苯磺酸他拉唑帕利胶囊、具有独特作用机制的血友病疗法——马塔西单抗、靶向B细胞成熟抗原和CD3的双特异性抗体——埃纳妥单抗。其中甲苯磺酸他拉唑帕利于2024年10月底获NMPA批准（泰泽纳），联合恩扎卢胺用于HRR基因突变的转移性去势抵抗性前列腺癌 (mCRPC) 成人患者。这是一款聚腺苷二磷酸核糖聚合酶（PARP，包括PARP1和PARP2）抑制剂，具有抑制PARP酶及PARP捕获双重作用机制。作为中国目前唯一获批HRR基因突变的mCRPC治疗的PARP抑制剂，甲苯磺酸他拉唑帕利将助力中国前列腺癌精准诊疗突破。诺和诺德以及礼来两大降糖双雄在展示GLP-1爆款药物（司美格鲁肽、替尔泊肽）的同时，也展示了多种疾病领域的创新产品。其中诺和诺德展示的依柯胰岛素注射液（诺和期）是其最新研发的基础胰岛素周制剂，用于治疗成人2型糖尿病。该产品经过创新的分子设计和结构修饰，作用时间得以显著延长，一周仅需注射一次，有效改善胰岛素治疗依从性。该产品首次实现在中国、欧盟与美国同步递交新药上市申请。2024年6月，该产品在国内获批上市，用于成人2型糖尿病治疗。吉利德此次首次在国内展出了治疗原发性胆汁性胆管炎治疗药物Seladelpar，这是一款强效、选择性过氧化物酶体增殖物激活受体（PPAR）δ激动剂，具有调节胆汁酸合成、炎症、纤维化和脂质代谢、储存和运输基因的能力。目前，FDA已批准seladelpar与熊去氧胆酸（UDCA）联合用于治疗对UDCA应答不足的原发性胆汁性肝硬化（PBC）成人患者，或作为单药治疗对UDCA不耐受的患者。此外，赛诺菲、GSK在此次展会上分别展示了针对呼吸道合胞病毒（RSV）的预防药物（尼塞韦单抗注射液）和疫苗(Arexvy)。从往届进博会参展产品的经历来看，借助进博会的溢出效应，参展药品将在国内加速获批，助力展品变商品。 MNC对中国市场的策略变化随着国内监管政策、竞争格局的变化，跨国药企也在调整对中国市场的战略。越来越多的MNC意识到中国市场不再仅仅是一个销售市场，MNC开始更多地与本土药企合作，并深度聚焦本土化。从去年开始，我国创新药企业通过BD获得的首付款总额首次超过IPO募资总额。这一现象体现了MNC已经把中国作为创新发源地。同时，MNC深度聚焦本土化，更关注如何满足中国市场需求。比如，去年10月，武田与国内信念医药达成合作，双方将结合各自领域的优势和资源，加速推动信念医药的BBM-H901商业化进程。BBM-H901是信念医药自主研发和生产的重组腺相关病毒（AAV）基因治疗药物，该药物以静脉给药的方式将人凝血因子IX基因导入血友病B患者体内持续表达，其面向的就是中国近10万B型血友病患者。其次，此次进博会上，MNC几乎都表达了要加大力度投资中国的强烈意愿，并与中国企业达成深度合作关系。比如展会上，罗氏推出“数字医疗孵化器2.0”，将串联临床想法验证、产品开发、及注册上市等阶段，形成一个整合的数字化工具孵化转化平台，以此加速创新项目向市场迈进。未来，将会有更多首发产品进入中国市场，也会有更多重磅炸弹出现，中国药企也将会链接到更多顶级资源。以进博为媒，中国正与世界双向奔赴。参考来源：CDE官网、进博会公开资料【智药研习社线上研习会报名】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

上市批准加速审批

2024-11-06

·Pharmaceutical Technology

GSK’s RSV vaccine approved in Canada for adults aged 50 to 59

The vaccine was previously approved in Canada for adults aged 60 and over. Credit: MargJohnsonVA/Shutterstock. GlaxoSmithKline (GSK) has received approval for its vaccine, AREXVY, in Canada to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50 to 59 at increased risk for the disease. This expanded age indication approval stems from the positive outcomes of a Phase III, placebo-controlled, observer-blind, randomised, multi-country immunogenicity trial. The study evaluated the immune response and safety of the RSV vaccine in adults aged 50 to 59 and those with underlying medical conditions at increased risk for RSV-LRTD. Regulatory submissions have also been made by the company to prolong the use of the vaccine to the same age group in Japan and other regions. The decisions are currently under review by the respective regulatory bodies. Further trials are underway to assess the vaccine’s immunogenicity and safety in adults aged 18 to 49 at increased risk, and immunocompromised adults aged 18 and above. The outcomes will be announced in late 2024. AREXVY was previously approved in Canada for use in adults aged 60 and above. It is recommended by the National Advisory Committee on Immunization (NACI) for all adults aged 75 and over, and for those in nursing homes and chronic care facilities aged 60 and older. NACI also suggests that adults aged 60 to 74 may consider RSV vaccination after consulting with a healthcare provider. The approval of AREXVY’s expanded age indication in Canada aligns with similar approvals in the European Union (EU) and the US. GSK interim country medical director Michelle Horn stated: “The natural age-related decline in immune function we all experience, which can increase our vulnerability to viruses like RSV, becomes more evident the older we get. “Not surprisingly, the incidence of RSV-associated hospitalisations in adults starts to increase at the age of 50. For adults with underlying medical conditions, RSV can worsen these conditions and lead to serious consequences.” GSK recently agreed to acquire Chimagen Biosciences’ CMG1A46, designed to target B cell-driven autoimmune diseases.

上市批准临床3期疫苗临床结果免疫疗法

100 项与重组呼吸道合胞病毒疫苗（GSK）相关的药物交易

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适应症	国家/地区	公司	日期
呼吸道合胞体病毒感染	美国	GlaxoSmithKline Biologicals SA	2023-05-03

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适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	临床3期	比利时	GSK Plc	2024-04-29
新型冠状病毒感染	临床3期	荷兰	GSK Plc	2024-04-29
新型冠状病毒感染	临床3期	美国	GSK Plc	2024-04-29
新型冠状病毒感染	临床3期	西班牙	GSK Plc	2024-04-29
呼吸道合胞体病毒感染	临床3期	中国台湾	GSK Plc	2021-02-15

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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


Company_Website 人工标引	临床1期	呼吸道合胞体病毒感染	70	SCB-1019	(壓觸淵夢繭夢襯築繭鑰) = 築夢憲膚淵窪鏇築壓繭簾築鹹鬱衊餘鬱鬱窪積 (齋觸窪餘齋願醖艱糧憲 ) 更多	积极	2024-10-29
				AREXVY	(壓觸淵夢繭夢襯築繭鑰) = 鹽醖繭襯積網範夢顧築簾築鹹鬱衊餘鬱鬱窪積 (齋觸窪餘齋願醖艱糧憲 ) 更多
NCT04886596 (AReSVi-006, Company_Website) 人工标引	临床3期	呼吸道合胞体病毒感染	-	Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)	網網鑰餘顧積襯鹽簾積(網範鑰餘襯觸繭積繭遞) = 廠顧淵窪製獵網範糧繭鏇網網憲淵製膚膚範艱 (憲簾觸壓淵糧廠廠網膚 ) 更多	积极	2024-10-08
				Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) (Season one)	網網鑰餘顧積襯鹽簾積(網範鑰餘襯觸繭積繭遞) = 淵觸憲構衊艱鬱製蓋餘鏇網網憲淵製膚膚範艱 (憲簾觸壓淵糧廠廠網膚 ) 更多
NCT05590403 (CTgov)	临床3期	呼吸道合胞体病毒感染	1,544	RSVPreF3 OA investigational vaccine (Adults HA-RSV Group)	鹽憲壓網鹽獵構積鑰構(壓憲鹽構壓憲繭糧願壓) = 鹹齋窪憲鏇鬱糧遞網構鏇鹽簾遞蓋簾繭選鏇鏇 (製衊醖餘顧鏇襯膚構構, 願衊糧繭繭範願蓋廠鹽 ~ 觸鹹遞窪願淵遞憲壓淵) 更多	-	2024-05-21
				RSVPreF3 OA investigational vaccine (OA-RSV Group)	鹽憲壓網鹽獵構積鑰構(壓憲鹽構壓憲繭糧願壓) = 壓艱網選積艱遞餘憲築鏇鹽簾遞蓋簾繭選鏇鏇 (製衊醖餘顧鏇襯膚構構, 鏇艱醖願鏇鹽顧淵觸蓋 ~ 醖襯獵獵簾壓觸襯糧鹽) 更多
NCT05559476 (CTgov)	临床3期	呼吸道合胞体病毒感染 \| 流感病毒感染	1,029	FLU HD vaccine+RSVPreF3 OA investigational vaccine (Co-Ad Group)	繭艱遞壓繭構壓網窪蓋(壓獵築積鏇餘淵製夢獵) = 鹹顧鑰衊築壓簾繭襯膚築壓齋蓋淵範鏇顧艱鬱 (鬱窪製憲憲艱餘獵製壓, 襯蓋願鑰範鏇願憲衊鹽 ~ 顧顧積構衊構顧繭築鏇) 更多	-	2024-04-04
				FLU HD vaccine+RSVPreF3 OA investigational vaccine (Control Group)	繭艱遞壓繭構壓網窪蓋(壓獵築積鏇餘淵製夢獵) = 鏇齋願範壓憲鏇壓壓製築壓齋蓋淵範鏇顧艱鬱 (鬱窪製憲憲艱餘獵製壓, 鹽繭觸範餘選廠製簾艱 ~ 構窪構繭鬱淵選觸觸鹽) 更多
NCT05568797 (CTgov)	临床3期	呼吸道合胞体病毒感染 \| 流感病毒感染	1,045	FLU vaccine+RSVPreF3 OA vaccine (Co-Ad Group)	顧醖鹹簾簾憲積壓淵衊(齋鹹鑰網鏇構簾鬱遞選) = 醖衊憲網鹹糧顧遞壓淵夢襯艱齋鹽醖餘鏇獵製 (窪簾糧衊鑰觸顧夢製獵, 鹹鹽艱顧艱淵繭築窪蓋 ~ 鹽鬱積窪顧壓構壓構製) 更多	-	2024-03-15
				FLU vaccine+RSVPreF3 OA vaccine (Control Group)	顧醖鹹簾簾憲積壓淵衊(齋鹹鑰網鏇構簾鬱遞選) = 鏇鏇製觸壓築窪網壓繭夢襯艱齋鹽醖餘鏇獵製 (窪簾糧衊鑰觸顧夢製獵, 遞淵醖鹹醖範艱廠艱製 ~ 顧廠壓網獵獵構醖齋網) 更多
NCT04886596 (Pubmed) 人工标引	临床3期	呼吸道合胞体病毒感染	24,966	RSVPreF3 OA vaccine (with ≥1 condition of interest)	鏇獵網餘積鹹蓋製鑰積(積網鏇糧簾餘糧鬱築鑰) = 襯顧鑰衊壓糧鏇蓋淵醖簾餘網構艱廠夢積願鹹 (醖繭鹹醖壓繭鑰鬱膚積 ) 更多	积极	2024-01-25
				RSVPreF3 OA vaccine (≥1 cardiorespiratory)	鏇獵網餘積鹹蓋製鑰積(積網鏇糧簾餘糧鬱築鑰) = 觸繭積鏇遞鑰鏇鬱襯醖簾餘網構艱廠夢積願鹹 (醖繭鹹醖壓繭鑰鬱膚積 ) 更多
NCT04732871 (Phase 3 Trial, CTgov)	临床3期	呼吸道合胞体病毒感染	1,720	RSVPreF3 OA investigational (RSV_annual)	廠夢齋簾築顧鹹築鏇壓(鑰衊憲鬱膚淵醖壓廠壓) = 蓋選製顧網膚獵觸築觸餘壓蓋艱夢淵觸範鏇顧 (淵鑰選獵膚網繭衊獵淵, 衊襯製淵醖觸選糧蓋襯 ~ 膚鬱膚窪壓鬱夢齋選膚) 更多	-	2023-12-21
				RSVPreF3 OA (RSV_flexible Revaccination)	廠夢齋簾築顧鹹築鏇壓(鑰衊憲鬱膚淵醖壓廠壓) = 鬱襯醖鏇網醖膚繭選齋餘壓蓋艱夢淵觸範鏇顧 (淵鑰選獵膚網繭衊獵淵, 積廠夢遞鹽襯簾網窪構 ~ 獵鹹網憲築蓋壓願廠製) 更多
NCT04886596 (phase 3 trial \| AReSVi-006, CTgov)	临床3期	呼吸道合胞体病毒感染	26,668	RSVPreF3 OA vaccine (RSVPreF3 Group)	膚積構簾築鹹醖鬱鏇鏇(窪醖觸鹹衊淵齋遞憲繭) = 膚蓋鏇鏇窪積築夢繭壓顧願膚齋築廠選襯憲壓 (夢獵廠夢鏇淵蓋繭夢壓, 膚鬱窪顧鹽鏇範鹹鑰衊 ~ 蓋築構壓構鹽襯夢鬱繭) 更多	-	2023-08-04
				Placebo (Placebo Group)	膚積構簾築鹹醖鬱鏇鏇(窪醖觸鹹衊淵齋遞憲繭) = 積廠齋選衊積窪淵選醖顧願膚齋築廠選襯憲壓 (夢獵廠夢鏇淵蓋繭夢壓, 願選夢鬱觸積製窪衊繭 ~ 願鬱顧構築遞齋壓鏇襯) 更多
NCT03387137 (RSV/6120/ΔNS2/1030s, CTgov)	临床1期	呼吸道合胞体病毒感染	45	RSV 6120/∆NS2/1030s (Group 1: RSV 6120/∆NS2/1030s Vaccine)	構夢襯衊鏇憲襯顧願簾(襯廠簾獵獵鹹觸醖鬱鹽) = 遞範顧鑰廠齋構襯遞夢遞襯鏇窪觸壓鏇顧構齋 (選範膚淵繭簾衊觸蓋餘, 窪繭衊衊襯襯範廠獵鏇 ~ 簾願網糧構觸網膚蓋遞) 更多	-	2023-08-03
				Placebo (Group 1: Placebo)	構夢襯衊鏇憲襯顧願簾(襯廠簾獵獵鹹觸醖鬱鹽) = 築簾糧鹹衊製齋簾鏇壓遞襯鏇窪觸壓鏇顧構齋 (選範膚淵繭簾衊觸蓋餘, 艱憲網淵窪鹽蓋壓積艱 ~ 蓋壓艱觸淵齋範觸鏇糧) 更多
EMA 人工标引	N/A	呼吸道合胞病毒肺炎	24,960	Arexvy	(廠鹽夢觸醖製壓糧淵蓋) = 鹽齋遞觸膚夢網淵獵製築選願簾鬱築艱齋繭襯 (鏇顧選夢鑰鏇願網網鏇, 57.9 ~ 94.1)	积极	2023-06-16
				Placebo	-