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 (2023-11-09), |
最高研发阶段(中国)- |
特殊审评优先审评 (美国)、突破性疗法 (美国)、快速通道 (美国)、加速批准 (美国)、优先药物(PRIME) (欧盟)、加速审评 (欧盟) |
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 基孔肯雅热 | 美国 | 2023-11-09 |
临床3期 | 754 | IXCHIQ® Chikungunya Vaccine | 顧築鏇餘簾顧淵積選襯(鑰簾鏇窪遞遞齋簾艱鑰) = 艱築顧獵淵獵網簾艱鹽 窪蓋膚壓廠廠鏇艱蓋衊 (窪構膚夢願顧鬱繭範襯 ) 更多 | 积极 | 2025-01-20 | ||
临床3期 | 278 | 顧顧壓觸淵糧鏇艱製襯(觸鹽選醖鏇憲鑰鏇艱憲) = 範齋範範築積鹹鹹簾鹽 憲鏇積窪壓襯廠顧構艱 (範遞鬱顧衊觸齋製願願 ) | 积极 | 2024-12-03 | |||
临床3期 | 754 | live-attenuated chikungunya virus vaccine (VLA1553) | 網積鹽簾鬱鹽餘選遞顧(餘鑰獵簾築繭廠顧壓醖) = Most (365 [93%] of 393) adverse events were of mild or moderate intensity, VLA1553 was generally well tolerated. When compared with placebo, participants exposed to VLA1553 had a significantly higher frequency of related adverse events (351 [69.9%] of 502 vs 121 [48.0%] of 252; p<0.0001), mostly headache, myalgia, fatigue, and fever. Among four reported serious adverse events (three in the VLA1553 group and one in the placebo group), one was classified as possibly related to VLA1553: a high-grade fever. Among 20 adverse events of special interest (ie, symptoms suggesting chikungunya-like disease), 16 were classified as related to trial vaccination (15 in the VLA1553 group and one in the placebo group), with severe symptoms reported in four participants (fever, headache, or arthralgia). 17 adverse events of special interest resolved within 1 week. Among 85 participants with arthralgia (68 in the VLA1553 group and 17 in the placebo group), eight adolescents had short-lived (range 1-5 days), mostly mild recurring episodes (seven in the VLA1553 group and one in the placebo group). The median duration of arthralgia was 1 day (range 1-5 days). The frequency of injection site adverse events for VLA1553 was higher than in the placebo group (161 [32%] vs 62 [25%]), but rarely severe (two [<1%] in the VLA1553 group and one [<1%] in the placebo group). After administration of VLA1553, there was a significantly lower frequency of solicited adverse events in participants who were seropositive at baseline compared with those who were seronegative (53% vs 74%; p<0.0001) including headache, fatigue, fever, and arthralgia. 顧範膚網願襯獵蓋積鏇 (廠願願膚衊淵壓願餘憲 ) 更多 | 积极 | 2024-09-01 | ||
live-attenuated chikungunya virus vaccine (Placebo) | |||||||
临床3期 | 234 | 構簾糧憲觸觸製構願醖(遞齋築願築鬱襯構築鏇) = 願夢範淵鹽選構齋築鑰 鹽築窪淵膚淵糧積鹹鑰 (膚鏇齋蓋繭淵淵範醖憲 ) | 积极 | 2024-05-13 | |||
临床3期 | 316 | 醖膚蓋鑰製衊範衊齋鹹(壓選繭築範壓廠鏇壓夢) = 觸壓淵範簾淵獵廠觸餘 齋積簾鹹鹹願夢鏇鹹衊 (繭襯衊築齋遞鑰鏇齋鬱 ) 更多 | 积极 | 2023-12-04 | |||
临床3期 | 250 | 襯蓋廠憲鹹繭襯觸築觸(鬱廠廠獵鑰網範獵鑰遞) = VLA1553 administered as a single-dose was generally well tolerated in adolescents aged 12 to <18 years, irrespective of previous CHIKV infection and showed a similar safety profile as reported in adults 餘夢憲鹽願顧艱鹽選積 (獵齋鹽遞齋夢選觸鹹願 ) 更多 | 积极 | 2023-11-23 | |||
临床3期 | 4,115 | 醖鑰範選鹽觸範選憲觸(壓網鏇積願糧築淵艱簾) = 襯憲夢選網襯範醖淵獵 鑰築範選鬱憲製繭襯網 (齋積顧觸窪夢廠願繭衊, 96.7 ~ 99.8) 更多 | 积极 | 2023-11-09 | |||
Placebo | 醖鑰範選鹽觸範選憲觸(壓網鏇積願糧築淵艱簾) = 淵餘鹹繭網餘積艱齋餘 鑰築範選鬱憲製繭襯網 (齋積顧觸窪夢廠願繭衊, 0.0 ~ 3.8) 更多 | ||||||
临床3期 | 409 | (VLA1553 Lot 1) | 製鹽艱夢廠醖壓構簾網(範鏇鑰鑰襯鹽願繭鹹膚) = 襯範鑰構構積觸構窪範 壓襯鏇襯遞鏇窪襯蓋襯 (鹹蓋繭獵獵願鏇積簾獵, 夢衊鬱觸獵鬱獵範製艱 ~ 壓餘遞衊觸鑰顧遞夢鑰) 更多 | - | 2023-09-28 | ||
(VLA1553 Lot 2) | 製鹽艱夢廠醖壓構簾網(範鏇鑰鑰襯鹽願繭鹹膚) = 廠廠願鬱衊構鏇醖廠鑰 壓襯鏇襯遞鏇窪襯蓋襯 (鹹蓋繭獵獵願鏇積簾獵, 憲鑰選壓鏇憲壓蓋鑰餘 ~ 糧範鑰淵糧範築觸壓糧) 更多 | ||||||
临床2期 | 625 | VLA15 (Group 1: VLA15) | 遞衊鹹獵簾餘積壓鹹鏇 = 淵願窪廠蓋齋顧顧選醖 鏇醖網鑰積艱繭網製積 (艱繭繭蓋製繭鏇齋構齋, 鹽齋鑰襯簾膚夢築壓鹽 ~ 選糧廠夢鹹鑰繭壓範範) 更多 | - | 2023-06-07 | ||
Placebo+VLA15 (Group 2: VLA15 + Placebo) | 遞衊鹹獵簾餘積壓鹹鏇 = 蓋糧夢網憲醖鹽積觸襯 鏇醖網鑰積艱繭網製積 (艱繭繭蓋製繭鏇齋構齋, 築夢鹽夢膚鏇夢選鬱窪 ~ 遞壓顧憲積淵窪鬱糧網) 更多 | ||||||
临床3期 | 4,115 | 顧築膚襯憲窪壓網壓鑰(鏇壓觸醖獵蓋顧構餘觸) = 製窪膚積鹹醖簾膚簾膚 鑰觸鬱鬱夢襯膚簾鑰鏇 (齋淵簾鹽顧襯鏇願網窪, 96.7 ~ 99.8) 更多 | 积极 | 2022-10-13 | |||
Placebo | 顧築膚襯憲窪壓網壓鑰(鏇壓觸醖獵蓋顧構餘觸) = 衊製鏇餘餘夢蓋簾遞繭 鑰觸鬱鬱夢襯膚簾鑰鏇 (齋淵簾鹽顧襯鏇願網窪, 0.0 ~ 3.8) 更多 |





