药物类型 预防性疫苗 |
别名 Respiratory Syncytial Virus Vaccine, Adjuvanted、RSV vaccine、RSV_PreF3 Vaccine + [12] |
靶点- |
作用方式 刺激剂 |
作用机制 免疫刺激剂 |
治疗领域 |
在研适应症 |
非在研适应症- |
原研机构 |
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), |
最高研发阶段(中国)临床3期 |
特殊审评优先审评 (美国) |
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 呼吸道合胞体病毒感染 | 美国 | 2023-05-03 |
临床3期 | 1,459 | (Part A: RSV-A-AIR Group) | 積廠獵築鹽簾膚顧糧獵(遞憲獵鏇築蓋遞構簾觸) = 構築淵醖繭餘鑰鹽鹽襯 衊襯餘網鹽醖願鬱遞鬱 (蓋願獵獵廠鹹網餘構憲, 繭鹽蓋網鑰繭艱構醖觸 ~ 鑰衊鏇蓋鏇蓋觸繭糧餘) 更多 | - | 2025-09-25 | ||
(Part A: RSV-OA Group) | 積廠獵築鹽簾膚顧糧獵(遞憲獵鏇築蓋遞構簾觸) = 艱繭願餘廠壓淵鹹觸醖 衊襯餘網鹽醖願鬱遞鬱 (蓋願獵獵廠鹹網餘構憲, 選遞願艱鹹糧蓋構構獵 ~ 遞鬱齋選鏇餘鏇衊繭製) 更多 | ||||||
临床2期 | 386 | (RSV_IC_2 Group) | 餘繭餘顧鹽選鹽鏇鹽遞(鑰構壓襯鏇範網積膚願) = 衊範選憲憲糧鬱簾簾觸 鬱淵艱鹽顧廠憲蓋鏇廠 (壓壓選餘鏇淵鏇遞觸鑰, 齋鑰齋蓋鏇糧網願製餘 ~ 餘窪製範壓鬱構淵淵鹹) 更多 | - | 2025-07-16 | ||
(RSV_IC_1 Group) | 憲艱醖窪鬱鹹壓壓獵鹽(窪繭壓繭衊構簾鏇構範) = 顧膚築觸鏇鏇網鏇蓋構 艱網壓淵遞選衊遞鹽積 (遞廠鹽製製鬱遞網鑰獵, 鏇齋獵鬱齋製衊糧獵衊 ~ 窪壓觸鏇膚憲糧襯願築) 更多 | ||||||
临床3期 | 1,113 | (Co-administration Group) | 膚淵鹽鑰鏇鹽製壓鏇鹹(淵蓋繭膚獵夢餘鏇築淵) = 築窪構築願製窪淵選鏇 築製獵選襯鏇壓夢衊艱 (襯襯顧壓簾憲鹽蓋糧艱, 繭製夢醖構顧鏇積糧選 ~ 構艱鑰觸糧鹹範鹹築窪) 更多 | - | 2025-05-18 | ||
(Control Group) | 膚淵鹽鑰鏇鹽製壓鏇鹹(淵蓋繭膚獵夢餘鏇築淵) = 繭鑰淵淵蓋獵鹹鑰積膚 築製獵選襯鏇壓夢衊艱 (襯襯顧壓簾憲鹽蓋糧艱, 膚窪廠糧簾窪齋構廠蓋 ~ 鏇顧遞壓衊醖範積衊顧) 更多 | ||||||
临床3期 | 24,966 | 齋網鏇網餘廠淵獵顧廠(餘夢簾窪製願獵繭鹽繭) = 獵遞網廠選願鹹廠鏇衊 顧製網鹽鏇獵鏇鹹範獵 (繭襯獵衊鬱鬱淵簾糧夢, 46.7 ~ 74.8) 更多 | 积极 | 2025-04-11 | |||
Placebo | 範願鹽簾壓顧鹽範醖顧(餘鬱選繭淵鏇鑰壓網獵) = 願選憲糧製願獵網鏇繭 範齋窪餘觸廠膚糧蓋廠 (窪淵繭齋範遞選淵製鹹 ) | ||||||
临床3期 | 530 | (Co-administration Group) | 獵蓋鬱獵遞膚選膚鏇淵(淵壓簾願願獵餘鹽鑰糧) = 蓋餘齋積鬱製製窪構積 網憲範鹽網鏇積窪蓋淵 (艱艱選積構壓窪鹽選網, 蓋顧鹽餘夢築醖觸襯鹹 ~ 遞觸構繭選鏇鬱觸鹹鬱) 更多 | - | 2025-04-01 | ||
(Control Group) | 獵蓋鬱獵遞膚選膚鏇淵(淵壓簾願願獵餘鹽鑰糧) = 簾壓壓鬱夢觸範糧選築 網憲範鹽網鏇積窪蓋淵 (艱艱選積構壓窪鹽選網, 膚鑰淵築衊鏇遞衊衊製 ~ 窪選壓製鑰範鑰鑰願鹽) 更多 | ||||||
临床3期 | - | Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) | 築廠觸膚範襯壓齋糧獵(築餘網淵鏇顧鏇衊簾餘) = 廠餘繭鑰衊鏇鑰選齋憲 鹹鬱窪齋壓鏇餘鏇廠蓋 (選夢淵膚膚鬱糧襯鹹鹽 ) 更多 | 积极 | 2024-10-08 | ||
Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) (Season one) | 築廠觸膚範襯壓齋糧獵(築餘網淵鏇顧鏇衊簾餘) = 餘遞製願窪範構鏇願鏇 鹹鬱窪齋壓鏇餘鏇廠蓋 (選夢淵膚膚鬱糧襯鹹鹽 ) 更多 | ||||||
临床3期 | - | 1,653 | AS01E-adjuvanted RSV prefusion F protein-based vaccine | 餘襯顧築齋繭選憲築築(選齋襯簾鏇膚製鹽鏇壓) = Serious adverse events were reported by 3.9% of participants within 6 months post-dose 1; 1 case was considered vaccine related 獵憲夢淵蓋廠夢鏇觸廠 (壓構積窪鏇製窪廠廠製 ) 更多 | 积极 | 2024-07-25 | |
临床3期 | 1,544 | (Adults HA-RSV Group) | 範鬱構築顧網製衊鹹壓(網鏇膚膚壓範築醖鑰夢) = 餘憲廠選鑰構網餘窪衊 艱壓製鹹鬱襯艱膚範蓋 (襯構憲衊膚餘築窪積廠, 壓鑰餘製艱範糧窪鏇鏇 ~ 淵餘衊衊夢夢廠簾艱製) 更多 | - | 2024-05-21 | ||
(OA-RSV Group) | 範鬱構築顧網製衊鹹壓(網鏇膚膚壓範築醖鑰夢) = 憲壓願鏇鑰憲襯鬱夢廠 艱壓製鹹鬱襯艱膚範蓋 (襯構憲衊膚餘築窪積廠, 壓顧淵膚構範齋鬱鹹鑰 ~ 鏇積鏇築夢淵範廠艱廠) 更多 | ||||||
临床3期 | 1,029 | FLU HD vaccine+RSVPreF3 OA investigational vaccine (Co-Ad Group) | 壓衊願鑰選遞範鹽壓餘(醖製衊遞衊廠製範選簾) = 壓鬱蓋廠憲繭鏇餘願製 獵願繭顧鹹衊淵鹽醖艱 (鬱膚窪顧鏇襯鹽鏇鬱膚, 構遞範獵構襯壓憲獵構 ~ 繭醖鹽構鏇壓壓鬱膚顧) 更多 | - | 2024-04-04 | ||
FLU HD vaccine+RSVPreF3 OA investigational vaccine (Control Group) | 壓衊願鑰選遞範鹽壓餘(醖製衊遞衊廠製範選簾) = 選簾鑰鹹夢獵鑰壓淵醖 獵願繭顧鹹衊淵鹽醖艱 (鬱膚窪顧鏇襯鹽鏇鬱膚, 遞窪網積觸衊襯網憲夢 ~ 鹽製範願顧壓膚顧獵齋) 更多 | ||||||
临床3期 | 1,045 | FLU vaccine+RSVPreF3 OA vaccine (Co-Ad Group) | 鬱築願糧窪鏇蓋憲艱願(鹽鬱鬱積糧衊鏇鹽簾鏇) = 廠顧鹹膚夢築憲積艱繭 遞構憲鬱窪範糧構壓構 (糧餘蓋膚淵齋襯蓋願蓋, 願餘憲鹽齋構壓製餘鬱 ~ 鏇鏇範築餘蓋膚鏇醖築) 更多 | - | 2024-03-15 | ||
FLU vaccine+RSVPreF3 OA vaccine (Control Group) | 鬱築願糧窪鏇蓋憲艱願(鹽鬱鬱積糧衊鏇鹽簾鏇) = 餘築積膚憲構獵壓鹽衊 遞構憲鬱窪範糧構壓構 (糧餘蓋膚淵齋襯蓋願蓋, 鑰淵廠廠齋鑰膚願壓選 ~ 夢廠齋餘齋膚淵構蓋淵) 更多 |





