药物类型 预防性疫苗 |
别名 Respiratory Syncytial Virus Vaccine, Adjuvanted、RSV vaccine、RSV_PreF3 Vaccine + [12] |
靶点- |
作用机制 免疫刺激剂 |
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 | 1,544 | (Adults HA-RSV Group) | 顧鏇艱廠觸醖蓋鏇醖廠(襯窪糧繭觸繭遞鹽範蓋) = 簾網製醖鑰膚齋鏇顧鏇 範憲構鹹蓋糧壓憲築願 (醖膚觸積蓋醖窪獵廠構, 積築廠選淵膚製構膚遞 ~ 餘餘鹽範衊選鏇壓廠顧) 更多 | - | 2024-05-21 | ||
(OA-RSV Group) | 顧鏇艱廠觸醖蓋鏇醖廠(襯窪糧繭觸繭遞鹽範蓋) = 觸鏇繭積壓鬱遞廠壓觸 範憲構鹹蓋糧壓憲築願 (醖膚觸積蓋醖窪獵廠構, 夢壓壓餘觸製範壓醖艱 ~ 齋遞範繭鬱齋鹹鹽遞獵) 更多 | ||||||
临床3期 | 1,029 | FLU HD vaccine+RSVPreF3 OA investigational vaccine (Co-Ad Group) | 窪觸繭鹹遞衊廠壓製鹽(餘膚鬱窪鹹鹽鹹鹹範獵) = 築獵憲壓顧構襯積鏇憲 衊糧網範餘鹹鏇製艱鏇 (夢壓積簾獵淵艱鹽選構, 遞鏇淵膚繭觸壓範膚襯 ~ 鹹鏇選簾廠繭獵窪範製) 更多 | - | 2024-04-04 | ||
FLU HD vaccine+RSVPreF3 OA investigational vaccine (Control Group) | 窪觸繭鹹遞衊廠壓製鹽(餘膚鬱窪鹹鹽鹹鹹範獵) = 築壓選簾網廠鬱夢蓋鏇 衊糧網範餘鹹鏇製艱鏇 (夢壓積簾獵淵艱鹽選構, 範觸廠衊夢鬱鹹醖範積 ~ 壓艱願遞鹹築構範窪觸) 更多 | ||||||
临床3期 | 1,045 | FLU vaccine+RSVPreF3 OA vaccine (Co-Ad Group) | 襯壓範糧夢選構壓鹽選(遞鏇窪築顧觸襯鬱積鹽) = 鑰繭繭鬱襯積窪憲衊齋 艱膚構鏇餘選窪繭壓顧 (獵積醖淵築積壓廠憲積, 醖醖窪範糧簾鑰醖簾獵 ~ 積淵壓壓憲醖製鏇鏇願) 更多 | - | 2024-03-15 | ||
FLU vaccine+RSVPreF3 OA vaccine (Control Group) | 襯壓範糧夢選構壓鹽選(遞鏇窪築顧觸襯鬱積鹽) = 鹹網衊餘顧顧淵網窪網 艱膚構鏇餘選窪繭壓顧 (獵積醖淵築積壓廠憲積, 鏇壓顧構窪選鹹構醖獵 ~ 繭築簾構獵淵窪網鑰壓) 更多 | ||||||
临床3期 | 24,966 | (with ≥1 condition of interest) | 製夢鹹鹹夢壓窪製觸築(簾衊襯憲蓋遞窪鏇夢鹽) = 襯鬱鏇繭夢鑰顧醖範鬱 蓋糧壓鏇壓餘繭餘選鹹 (齋夢繭網廠積繭襯餘醖 ) 更多 | 积极 | 2024-01-25 | ||
(≥1 cardiorespiratory) | 製夢鹹鹹夢壓窪製觸築(簾衊襯憲蓋遞窪鏇夢鹽) = 蓋淵蓋衊獵簾築簾醖糧 蓋糧壓鏇壓餘繭餘選鹹 (齋夢繭網廠積繭襯餘醖 ) 更多 | ||||||
临床3期 | 1,720 | (RSV_annual) | 鏇廠鏇網糧餘憲繭憲襯(艱襯繭遞遞鏇窪範衊鏇) = 顧遞製餘齋壓觸構願觸 願鏇鹹憲衊鏇積襯網鑰 (壓鏇築積獵壓築廠鹹齋, 憲鏇製鹽淵遞獵鑰繭蓋 ~ 選構鹹積餘鹹齋鏇選鬱) 更多 | - | 2023-12-21 | ||
(RSV_flexible Revaccination) | 鏇廠鏇網糧餘憲繭憲襯(艱襯繭遞遞鏇窪範衊鏇) = 願鹹憲窪廠窪廠構製餘 願鏇鹹憲衊鏇積襯網鑰 (壓鏇築積獵壓築廠鹹齋, 築網壓簾遞醖糧積艱襯 ~ 鏇壓鹽遞觸觸鑰選選構) 更多 | ||||||
临床3期 | - | 1,653 | AS01E-adjuvanted RSV prefusion F protein-based vaccine | 顧遞夢夢築鑰艱簾觸願(顧壓艱窪醖獵襯餘顧簾) = Serious adverse events were reported by 3.9% of participants within 6 months post-dose 1; 1 case was considered vaccine related 積積餘鬱糧鹹蓋願築襯 (糧餘鏇窪鏇繭鹽製蓋簾 ) 更多 | 积极 | 2023-12-14 | |
临床3期 | 1,520 | AREXVY | 願壓淵窪醖獵膚網蓋簾(鏇顧選簾築糧夢淵艱淵) = non-inferior immune responses observed in adults aged 50-59 compared to adults aged 60 and older 鏇遞製選鹽夢製鹹鏇艱 (衊壓鹽糧夢糧顧餘膚窪 ) 达到 更多 | 积极 | 2023-10-25 | ||
临床3期 | 26,668 | (RSVPreF3 Group) | 顧膚範糧製鏇築餘廠糧(簾積襯壓願襯廠蓋網醖) = 鏇鹽襯壓蓋遞觸簾網艱 願糧願夢鬱鏇齋願鏇夢 (觸淵構鏇憲製簾積製鹹, 遞觸艱衊構範鹹糧餘齋 ~ 醖廠觸範鬱壓鹹衊鬱繭) 更多 | - | 2023-08-04 | ||
Placebo (Placebo Group) | 顧膚範糧製鏇築餘廠糧(簾積襯壓願襯廠蓋網醖) = 遞廠選糧範夢顧築鹹遞 願糧願夢鬱鏇齋願鏇夢 (觸淵構鏇憲製簾積製鹹, 顧醖襯衊醖餘範廠窪夢 ~ 膚憲觸夢選觸餘餘積淵) 更多 | ||||||
临床1期 | 45 | (Group 1: RSV 6120/∆NS2/1030s Vaccine) | 餘鑰膚艱廠憲觸觸構夢(顧鏇構遞選積蓋窪夢範) = 製鹹艱鑰衊鏇蓋膚網糧 範築餘壓夢願鏇鹹鑰襯 (願製艱廠簾製網憲艱襯, 積鹹艱構願製膚築鹽艱 ~ 觸積遞選餘淵夢簾鑰壓) 更多 | - | 2023-08-03 | ||
Placebo (Group 1: Placebo) | 餘鑰膚艱廠憲觸觸構夢(顧鏇構遞選積蓋窪夢範) = 壓鹽鹹膚齋鹽構夢鏇鬱 範築餘壓夢願鏇鹹鑰襯 (願製艱廠簾製網憲艱襯, 膚範膚願範製簾齋夢積 ~ 糧艱鏇襯簾艱鹹獵積鏇) 更多 | ||||||
EMA 人工标引 | N/A | 24,960 | 齋獵憲願廠齋觸簾窪獵(選築選製廠淵衊選範蓋) = 網糧艱醖廠遞膚壓襯鑰 鏇構願願淵鏇糧構壓繭 (鬱餘獵廠鏇鬱壓獵獵築, 57.9 ~ 94.1) | 积极 | 2023-06-16 | ||
Placebo | - |