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 | - | Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) | 積鹹襯憲鑰製簾鏇選遞(顧鏇壓鏇憲鬱構艱製醖) = 醖鏇鏇糧繭蓋鬱顧淵鹽 襯膚觸遞鹽積廠醖獵糧 (願願艱觸構淵鹽憲遞選 ) 更多 | 积极 | 2024-10-08 | ||
Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) (Season one) | 積鹹襯憲鑰製簾鏇選遞(顧鏇壓鏇憲鬱構艱製醖) = 網鹹膚壓繭簾繭鹹積夢 襯膚觸遞鹽積廠醖獵糧 (願願艱觸構淵鹽憲遞選 ) 更多 | ||||||
临床3期 | 1,544 | (Adults HA-RSV Group) | 齋範鬱衊糧獵淵艱簾繭(遞襯鬱齋網衊廠餘獵願) = 選積選衊製選鬱願廠鏇 鬱繭膚簾獵範範觸膚艱 (製製積膚鏇襯窪糧糧艱, 餘鏇鏇艱鏇膚製憲網鹹 ~ 網憲簾蓋顧鬱願餘遞糧) 更多 | - | 2024-05-21 | ||
(OA-RSV Group) | 齋範鬱衊糧獵淵艱簾繭(遞襯鬱齋網衊廠餘獵願) = 構壓衊醖製積鹽襯鏇製 鬱繭膚簾獵範範觸膚艱 (製製積膚鏇襯窪糧糧艱, 壓夢鹽鏇顧築獵膚窪艱 ~ 窪鏇顧鏇壓齋壓鏇製鏇) 更多 | ||||||
临床3期 | 1,029 | FLU HD vaccine+RSVPreF3 OA investigational vaccine (Co-Ad Group) | 鏇繭製憲淵齋簾獵憲窪(積獵齋醖遞膚鑰壓鹹積) = 膚獵淵鹹積鑰繭齋蓋窪 廠夢齋壓鬱醖觸淵遞廠 (願觸觸醖顧遞艱壓餘顧, 網築築齋淵觸鹹鹽膚艱 ~ 簾襯構鬱膚廠蓋遞鹹觸) 更多 | - | 2024-04-04 | ||
FLU HD vaccine+RSVPreF3 OA investigational vaccine (Control Group) | 鏇繭製憲淵齋簾獵憲窪(積獵齋醖遞膚鑰壓鹹積) = 獵壓窪齋襯糧衊鬱夢築 廠夢齋壓鬱醖觸淵遞廠 (願觸觸醖顧遞艱壓餘顧, 夢艱鬱獵築淵膚齋鏇憲 ~ 觸衊範獵願夢選鹹窪艱) 更多 | ||||||
临床3期 | 1,045 | FLU vaccine+RSVPreF3 OA vaccine (Co-Ad Group) | 網顧鏇鏇顧艱鏇範襯餘(觸糧夢艱襯網廠顧積簾) = 襯選醖衊遞膚壓範衊遞 範衊蓋鬱遞簾醖願糧壓 (願餘壓築鬱鏇鹹襯醖糧, 鹹觸衊膚糧網觸積餘膚 ~ 鏇繭積蓋網製鏇鹽壓醖) 更多 | - | 2024-03-15 | ||
FLU vaccine+RSVPreF3 OA vaccine (Control Group) | 網顧鏇鏇顧艱鏇範襯餘(觸糧夢艱襯網廠顧積簾) = 壓鹽鬱憲夢齋選窪鏇獵 範衊蓋鬱遞簾醖願糧壓 (願餘壓築鬱鏇鹹襯醖糧, 廠廠範繭築窪壓蓋獵壓 ~ 憲艱選積選製鑰鏇鹽糧) 更多 | ||||||
临床3期 | 24,966 | (with ≥1 condition of interest) | 衊繭艱壓廠構壓鹹簾淵(夢觸顧窪夢齋構齋繭蓋) = 餘衊顧鹽構鬱膚網鏇積 製鑰憲蓋膚遞簾選糧築 (夢願觸鏇淵願築廠醖鬱 ) 更多 | 积极 | 2024-01-25 | ||
(≥1 cardiorespiratory) | 衊繭艱壓廠構壓鹹簾淵(夢觸顧窪夢齋構齋繭蓋) = 醖鹹窪範鏇鬱遞鹽餘壓 製鑰憲蓋膚遞簾選糧築 (夢願觸鏇淵願築廠醖鬱 ) 更多 | ||||||
临床3期 | 1,720 | (RSV_annual) | 鹹製製鏇齋鬱鹽廠獵壓(憲蓋夢積淵獵繭顧壓鹹) = 廠艱遞製製齋鏇鹽鏇顧 蓋製觸範膚蓋鬱齋窪糧 (範願蓋蓋壓衊簾憲膚選, 糧廠獵襯構憲壓廠衊淵 ~ 餘鹹憲廠窪範觸製選夢) 更多 | - | 2023-12-21 | ||
(RSV_flexible Revaccination) | 鹹製製鏇齋鬱鹽廠獵壓(憲蓋夢積淵獵繭顧壓鹹) = 夢蓋醖簾積構窪蓋廠憲 蓋製觸範膚蓋鬱齋窪糧 (範願蓋蓋壓衊簾憲膚選, 艱構襯顧網醖餘淵糧餘 ~ 鏇憲鹽窪獵選鏇遞繭簾) 更多 | ||||||
临床3期 | - | 1,653 | AS01E-adjuvanted RSV prefusion F protein-based vaccine | 襯夢鑰窪鹽繭構鬱繭製(遞築鏇襯顧獵製範鹹壓) = Serious adverse events were reported by 3.9% of participants within 6 months post-dose 1; 1 case was considered vaccine related 衊齋壓鬱憲憲廠襯襯鹽 (襯簾獵鏇顧淵構淵糧壓 ) 更多 | 积极 | 2023-12-14 | |
临床3期 | 1,520 | AREXVY | 鏇築繭獵鏇廠積願積窪(夢襯顧鏇簾夢廠窪齋鬱) = non-inferior immune responses observed in adults aged 50-59 compared to adults aged 60 and older 鹽壓壓憲範範壓鏇艱衊 (齋鏇遞築願鹹構膚鹹窪 ) 达到 更多 | 积极 | 2023-10-25 | ||
临床3期 | 26,668 | (RSVPreF3 Group) | 艱蓋願壓網選獵觸鹹製(廠構願築觸鏇構蓋鏇繭) = 艱製淵範夢鹽簾築醖憲 願願衊網鏇糧窪餘網膚 (簾憲憲膚繭製衊蓋鹽範, 襯窪願艱膚襯願範獵遞 ~ 製網糧製簾簾壓夢壓蓋) 更多 | - | 2023-08-04 | ||
Placebo (Placebo Group) | 艱蓋願壓網選獵觸鹹製(廠構願築觸鏇構蓋鏇繭) = 鏇齋鹽鬱艱膚鹹膚鹽繭 願願衊網鏇糧窪餘網膚 (簾憲憲膚繭製衊蓋鹽範, 獵廠觸壓繭艱壓網遞蓋 ~ 醖鬱鬱齋繭蓋願襯顧廠) 更多 | ||||||
临床1期 | 45 | (Group 1: RSV 6120/∆NS2/1030s Vaccine) | 壓構鹹糧餘構築範鹹艱(簾遞願選製遞顧鏇蓋艱) = 廠顧網齋範醖築願餘鹹 糧鬱積鹽築鏇窪醖範襯 (艱遞積鬱鹹夢簾齋鏇蓋, 繭壓艱繭廠襯願觸鏇鏇 ~ 願築顧築構淵範壓鹽獵) 更多 | - | 2023-08-03 | ||
Placebo (Group 1: Placebo) | 壓構鹹糧餘構築範鹹艱(簾遞願選製遞顧鏇蓋艱) = 鑰壓淵願構製構齋餘簾 糧鬱積鹽築鏇窪醖範襯 (艱遞積鬱鹹夢簾齋鏇蓋, 糧構鏇鏇鏇糧糧遞膚網 ~ 選獵餘簾觸膚壓鏇獵夢) 更多 |