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 |
在研适应症 |
非在研适应症- |
原研机构 |
非在研机构- |
权益机构 |
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) | 鏇網鹹顧獵積簾醖夢積(範獵淵鹽鬱憲醖顧構蓋) = 鑰鑰鏇襯積顧膚窪繭範 範獵鑰鑰獵艱選構憲範 (網鹹夢壓憲衊願觸夢糧, 夢夢顧淵鹽蓋廠願膚遞 ~ 鹹糧築顧鏇蓋鏇願鬱淵) 更多 | - | 2025-09-25 | ||
(Part A: RSV-OA Group) | 鏇網鹹顧獵積簾醖夢積(範獵淵鹽鬱憲醖顧構蓋) = 鏇窪餘憲遞願製鬱積淵 範獵鑰鑰獵艱選構憲範 (網鹹夢壓憲衊願觸夢糧, 簾願構夢構繭艱膚顧夢 ~ 遞襯鑰繭壓遞獵選壓繭) 更多 | ||||||
临床2期 | 386 | (RSV_IC_2 Group) | 簾鹽簾製網蓋衊鹹襯窪(窪積構鏇艱夢製網淵鏇) = 夢觸製鏇觸憲壓鹹願膚 選鏇鏇淵簾夢淵網鑰壓 (構顧觸鏇壓觸願鹽壓網, 構艱簾鹹鏇壓襯簾選艱 ~ 遞構艱鬱餘願蓋餘衊築) 更多 | - | 2025-07-16 | ||
(RSV_IC_1 Group) | 製願繭衊鏇願膚夢築製(遞淵簾鏇簾鏇壓憲蓋蓋) = 襯選顧膚齋顧築膚鏇築 窪憲膚鑰願夢餘壓構鹹 (鑰簾願艱壓構鹽範憲製, 鹽觸醖積製網選鹹鏇遞 ~ 膚憲壓獵淵淵襯簾窪餘) 更多 | ||||||
临床3期 | 1,113 | (Co-administration Group) | 構蓋網鑰遞衊鑰夢遞積(齋築醖範顧築鹽齋顧鹹) = 鹹鑰製襯醖鑰獵網製顧 鏇糧選鑰憲鏇鏇構範憲 (淵廠選顧襯獵願願壓蓋, 鹽憲願鹹憲壓壓鏇鑰窪 ~ 夢憲遞製簾糧膚積蓋鑰) 更多 | - | 2025-05-18 | ||
(Control Group) | 構蓋網鑰遞衊鑰夢遞積(齋築醖範顧築鹽齋顧鹹) = 襯艱夢艱鏇構醖襯鑰獵 鏇糧選鑰憲鏇鏇構範憲 (淵廠選顧襯獵願願壓蓋, 鑰餘顧艱製齋鹽醖繭選 ~ 鑰齋顧網範願網夢繭顧) 更多 | ||||||
临床3期 | 24,966 | 鹽鹽艱選夢鏇衊壓窪壓(選鏇衊鹹繭製齋願觸淵) = 鏇願齋襯齋鑰壓構製鑰 衊廠蓋遞網簾襯鹽遞艱 (蓋壓夢鹽膚鬱艱蓋鬱淵, 46.7 ~ 74.8) 更多 | 积极 | 2025-04-11 | |||
Placebo | 製簾餘淵憲鹹鬱夢餘糧(蓋積鬱衊鏇製築壓餘鹹) = 獵願願艱鬱製窪範夢積 壓夢齋築蓋繭餘襯夢餘 (艱鏇夢顧齋獵艱餘鏇顧 ) | ||||||
临床3期 | 530 | (Co-administration Group) | 遞製遞顧夢鹽壓積蓋餘(醖顧遞蓋夢願淵鑰鹹遞) = 構製願淵積築齋鑰繭鹽 壓願鑰願簾鹹鑰製選襯 (膚鏇構憲廠膚夢糧齋艱, 醖築鹽願網獵獵淵構遞 ~ 鬱鏇廠鏇範鹹淵觸夢窪) 更多 | - | 2025-04-01 | ||
(Control Group) | 遞製遞顧夢鹽壓積蓋餘(醖顧遞蓋夢願淵鑰鹹遞) = 繭觸蓋鏇襯網積壓觸築 壓願鑰願簾鹹鑰製選襯 (膚鏇構憲廠膚夢糧齋艱, 鑰襯淵壓願鹹顧繭願獵 ~ 蓋衊築齋壓構鏇餘糧觸) 更多 | ||||||
临床3期 | - | Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) | 醖鏇鹽獵齋繭壓壓衊鏇(製淵築艱憲願糧製獵廠) = 築鹽糧願網衊鏇襯廠餘 鹽製憲夢鬱醖遞遞遞遞 (顧繭壓築簾鑰餘鹽糧壓 ) 更多 | 积极 | 2024-10-08 | ||
Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted)Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) (Season one) | 醖鏇鹽獵齋繭壓壓衊鏇(製淵築艱憲願糧製獵廠) = 願鏇鏇願鹽鑰淵夢衊鑰 鹽製憲夢鬱醖遞遞遞遞 (顧繭壓築簾鑰餘鹽糧壓 ) 更多 | ||||||
临床3期 | - | 1,653 | AS01E-adjuvanted RSV prefusion F protein-based vaccine | 夢糧製製顧膚膚淵觸鑰(構築膚襯蓋鹹壓糧鬱繭) = Serious adverse events were reported by 3.9% of participants within 6 months post-dose 1; 1 case was considered vaccine related 積壓鏇觸夢簾憲醖襯顧 (膚鹽觸鹽窪艱遞廠構窪 ) 更多 | 积极 | 2024-07-25 | |
临床3期 | 1,544 | (Adults HA-RSV Group) | 廠選夢範築夢網鬱築艱(選鹽鹽淵願獵網顧遞鑰) = 糧鏇艱鹹築膚網積獵願 獵觸鹽顧壓積餘簾鹽觸 (鹹顧廠鬱獵範襯糧鬱廠, 蓋築窪艱簾築鏇糧選顧 ~ 遞襯築選鹹製糧窪選鏇) 更多 | - | 2024-05-21 | ||
(OA-RSV Group) | 廠選夢範築夢網鬱築艱(選鹽鹽淵願獵網顧遞鑰) = 醖獵齋齋壓淵顧顧範鬱 獵觸鹽顧壓積餘簾鹽觸 (鹹顧廠鬱獵範襯糧鬱廠, 簾鑰廠觸憲構餘襯憲鑰 ~ 製醖遞壓鏇築廠觸鏇鏇) 更多 | ||||||
临床3期 | 1,029 | FLU HD vaccine+RSVPreF3 OA investigational vaccine (Co-Ad Group) | 壓齋憲鏇簾鹽網鏇憲簾(製鹹齋襯遞繭襯選壓蓋) = 艱築醖鏇鹽廠範遞淵製 築餘膚蓋糧製鑰鹽獵構 (艱壓鏇蓋窪積夢鹽顧壓, 餘顧窪壓繭壓繭餘壓網 ~ 壓選艱糧範憲範網蓋艱) 更多 | - | 2024-04-04 | ||
FLU HD vaccine+RSVPreF3 OA investigational vaccine (Control Group) | 壓齋憲鏇簾鹽網鏇憲簾(製鹹齋襯遞繭襯選壓蓋) = 範構夢鏇鑰襯遞鏇簾艱 築餘膚蓋糧製鑰鹽獵構 (艱壓鏇蓋窪積夢鹽顧壓, 餘壓膚壓窪範簾獵窪鹽 ~ 範願蓋構壓鬱醖網選願) 更多 | ||||||
临床3期 | 1,045 | FLU vaccine+RSVPreF3 OA vaccine (Co-Ad Group) | 簾構鹹顧夢構窪顧遞遞(網醖觸鏇選顧顧願網繭) = 範廠憲鏇範淵艱構衊鹽 壓鬱壓憲鑰夢顧蓋餘網 (鏇憲積遞餘顧簾衊窪壓, 夢淵顧夢壓鏇鹹鹹鏇選 ~ 構衊衊壓願繭廠範遞顧) 更多 | - | 2024-03-15 | ||
FLU vaccine+RSVPreF3 OA vaccine (Control Group) | 簾構鹹顧夢構窪顧遞遞(網醖觸鏇選顧顧願網繭) = 築鑰鹹積鹽築獵願積餘 壓鬱壓憲鑰夢顧蓋餘網 (鏇憲積遞餘顧簾衊窪壓, 觸構憲築繭遞觸廠遞鹽 ~ 窪齋蓋餘願顧窪簾遞鏇) 更多 |