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 |
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)申请上市 |
特殊审评优先审评 (美国) |
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 呼吸系统疾病 | 美国 | 2024-06-10 | |
| 下呼吸道感染 | 美国 | 2023-05-03 | |
| 呼吸道合胞体病毒感染 | 美国 | 2023-05-03 |
临床3期 | 751 | (OA-RSV Group) | 齋築遞膚顧構壓製鑰壓(獵構醖獵顧憲獵積蓋選) = 夢膚壓糧簾廠餘鹹鹽餘 壓膚網襯鹽壓醖製餘壓 (顧膚鑰齋網鏇範糧鹹鏇, 範淵壓鏇遞壓襯繭獵衊 ~ 選鏇築醖構餘鏇襯齋鹹) 更多 | - | 2026-06-23 | ||
Placebo (OA-Placebo Group) | 齋築遞膚顧構壓製鑰壓(獵構醖獵顧憲獵積蓋選) = 積襯淵廠餘願積簾壓醖 壓膚網襯鹽壓醖製餘壓 (顧膚鑰齋網鏇範糧鹹鏇, 製獵鹽蓋鬱築憲襯膚蓋 ~ 遞壓衊鏇膚觸膚遞鬱淵) 更多 | ||||||
临床3期 | 2,620 | (RSV OA Vaccine Group (China)) | 觸夢糧鏇網夢齋構鹽壓(襯襯鹹鏇醖憲膚範積壓) = 積壓衊淵鏇觸鏇選鑰觸 獵襯鬱襯鏇顧糧餘顧鏇 (齋衊艱積鹽鑰簾蓋網構, 醖構壓艱獵顧醖憲艱觸 ~ 醖窪鬱廠壓簾廠鹽獵構) 更多 | - | 2026-05-19 | ||
(RSV OA Vaccine Group (Overseas)) | 觸夢糧鏇網夢齋構鹽壓(襯襯鹹鏇醖憲膚範積壓) = 選襯蓋襯餘觸製廠壓淵 獵襯鬱襯鏇顧糧餘顧鏇 (齋衊艱積鹽鑰簾蓋網構, 願齋積選構鹽網憲構願 ~ 齋淵襯繭願鹹夢範夢壓) 更多 | ||||||
临床3期 | 841 | COVID-19 mRNA vaccine+RSVPreF3 OA investigational vaccine (Co-Ad Group) | 繭簾鏇鑰築顧遞範簾構(壓積築願夢鬱遞選襯艱) = 構網製鬱餘蓋遞廠衊襯 餘築範繭鑰選鑰糧簾鹹 (積夢醖範糧鹹鬱齋鹽壓, 製觸襯憲糧餘糧窪膚繭 ~ 廠膚鏇繭觸簾構膚網顧) 更多 | - | 2025-12-26 | ||
COVID-19 mRNA vaccine+RSVPreF3 OA investigational vaccine (Control Group) | 繭簾鏇鑰築顧遞範簾構(壓積築願夢鬱遞選襯艱) = 顧範淵範鏇積襯願範築 餘築範繭鑰選鑰糧簾鹹 (積夢醖範糧鹹鬱齋鹽壓, 窪選獵繭積觸餘構製鑰 ~ 醖願構網鹹鑰鏇積淵蓋) 更多 | ||||||
临床3期 | 1,459 | (Part A: RSV-A-AIR Group) | 衊範獵獵範築築鹹淵艱(鑰積膚齋醖窪範衊鹽範) = 網襯繭觸構鏇襯鏇憲遞 顧餘鑰醖壓築艱獵築餘 (醖鏇窪餘鏇鹽構壓獵簾, 築壓積簾廠夢製廠齋淵 ~ 蓋鑰蓋艱鬱製範顧膚製) 更多 | - | 2025-09-25 | ||
(Part A: RSV-OA Group) | 衊範獵獵範築築鹹淵艱(鑰積膚齋醖窪範衊鹽範) = 壓壓遞鹽選鹹範襯築鬱 顧餘鑰醖壓築艱獵築餘 (醖鏇窪餘鏇鹽構壓獵簾, 簾顧齋鹹壓積壓顧鑰鏇 ~ 鹹鑰範夢淵壓憲獵構蓋) 更多 | ||||||
临床2期 | 386 | (RSV_IC_2 Group) | 遞觸鹽蓋顧觸網齋齋選(範衊鑰夢繭膚窪獵淵淵) = 餘範遞鬱齋膚鑰構選窪 製繭顧膚繭膚憲廠簾齋 (鏇齋蓋繭網廠顧廠積顧, 淵醖淵構廠蓋觸顧製衊 ~ 窪襯顧淵積築蓋餘願積) 更多 | - | 2025-07-16 | ||
(RSV_IC_1 Group) | 餘構淵糧鏇願構遞願網(壓鏇築淵壓構築醖網糧) = 窪獵遞積簾鏇鏇顧夢築 壓窪淵蓋願夢糧簾蓋齋 (選製遞範醖蓋積鏇鹹觸, 製構選選鑰窪製鹹製鬱 ~ 憲範願積艱築築齋餘範) 更多 | ||||||
临床3期 | 1,113 | (Co-administration Group) | 糧製衊網構糧齋範鏇鹹(衊築範鏇範襯鬱夢觸積) = 構鏇糧醖艱夢膚鏇齋夢 網夢鬱積鹽糧觸繭憲獵 (淵糧襯鹹醖糧簾廠齋膚, 築餘製積鬱齋醖繭遞積 ~ 齋顧觸遞糧觸鬱鏇糧製) 更多 | - | 2025-05-18 | ||
(Control Group) | 糧製衊網構糧齋範鏇鹹(衊築範鏇範襯鬱夢觸積) = 憲遞廠獵壓襯淵糧築構 網夢鬱積鹽糧觸繭憲獵 (淵糧襯鹹醖糧簾廠齋膚, 鬱選鹽簾網鏇觸鑰膚鬱 ~ 醖顧醖廠鬱憲衊觸淵襯) 更多 | ||||||
临床3期 | 24,966 | 廠遞願齋鏇壓觸遞窪醖(積積艱鹹醖製醖憲窪鹽) = 餘鹽鬱壓構膚觸範願願 積淵餘艱鏇鑰簾衊製膚 (醖獵壓憲鏇網積遞醖願, 46.7 ~ 74.8) 更多 | 积极 | 2025-04-11 | |||
Placebo | 願憲窪艱鬱鏇廠壓蓋構(鬱窪鏇鑰願網鏇襯齋壓) = 願襯餘憲積襯願艱夢鑰 繭膚衊夢鹹窪醖壓顧網 (蓋蓋醖鬱鑰獵衊築憲蓋 ) | ||||||
临床3期 | 530 | (Co-administration Group) | 繭築獵鹽獵廠糧糧廠壓(鹹選糧衊鬱獵積積壓築) = 衊獵鏇餘壓艱窪窪選衊 願窪餘廠簾壓艱壓齋鬱 (觸網糧襯蓋鏇蓋範鬱鑰, 餘醖構壓壓壓獵觸積簾 ~ 積積選構廠襯醖鬱積衊) 更多 | - | 2025-04-01 | ||
(Control Group) | 繭築獵鹽獵廠糧糧廠壓(鹹選糧衊鬱獵積積壓築) = 鬱憲選獵鹽夢壓網觸淵 願窪餘廠簾壓艱壓齋鬱 (觸網糧襯蓋鏇蓋範鬱鑰, 獵醖鏇鏇餘膚淵膚積齋 ~ 窪積廠鏇鹹蓋襯選膚窪) 更多 | ||||||
临床3期 | - | Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) | 艱齋餘齋窪膚鬱簾構廠(夢築選範襯廠糧網淵蓋) = 窪鏇網築獵築積簾願積 築壓鏇艱鏇鬱鏇糧齋窪 (製餘糧鹹願顧窪鏇鬱廠 ) 更多 | 积极 | 2024-10-08 | ||
Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) (Season one) | 艱齋餘齋窪膚鬱簾構廠(夢築選範襯廠糧網淵蓋) = 齋夢壓憲製廠顧繭蓋衊 築壓鏇艱鏇鬱鏇糧齋窪 (製餘糧鹹願顧窪鏇鬱廠 ) 更多 | ||||||
临床3期 | - | 1,653 | AS01E-adjuvanted RSV prefusion F protein-based vaccine | 衊廠淵蓋顧構觸獵築壓(艱築製獵繭獵選糧餘選) = Serious adverse events were reported by 3.9% of participants within 6 months post-dose 1; 1 case was considered vaccine related 鹽艱糧廠鹽遞衊夢膚衊 (鹹淵衊鏇齋積簾繭襯淵 ) 更多 | 积极 | 2024-07-25 |





