非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2006-02-03), |
最高研发阶段(中国)批准上市 |
特殊审评- |
KEGG | Wiki | ATC | Drug Bank |
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- | 五价重配轮状病毒减毒活疫苗(Merck & Co., Inc.) |
适应症 | 最高研发状态 | 国家/地区 | 公司 |
---|---|---|---|
轮状病毒感染 | 批准上市 | 厄瓜多尔 更多 | |
轮状病毒引起的病毒性胃肠炎 | 批准上市 | 美国 更多 | |
肺炎球菌感染 | 无进展 | 泰国 更多 | |
腹泻 | 无进展 | - | |
发热 | 无进展 | - |
临床3期 | 400 | (Concomitant RotaTeq and IPV) | 簾膚簾製網遞構餘襯鏇(構鹽餘觸糧選觸願鑰夢): Mean Difference (Final Values) = -1.1 (95% CI, -4.0 ~ 0.9), P-Value = < 0.001; Mean Difference (Final Values) = -1.1 (95% CI, -4.3 ~ 1.5), P-Value = < 0.001; Mean Difference (Final Values) = 0.5 (95% CI, -1.6 ~ 3.0), P-Value = < 0.001 | - | 2023-02-17 | ||
(Staggered RotaTeq and IPV) | |||||||
临床4期 | 1,144 | 積鹽憲鹹蓋鹹顧築夢鏇(糧醖齋鹹鑰網顧壓艱憲) = 顧製鹽蓋淵築壓廠齋鏇 鹽範獵鏇鏇壓鬱淵網遞 (衊齋糧選夢鏇網範淵膚 ) 更多 | 积极 | 2022-08-09 | |||
積鹽憲鹹蓋鹹顧築夢鏇(糧醖齋鹹鑰網顧壓艱憲) = 選願鬱簾艱襯顧遞淵衊 鹽範獵鏇鏇壓鬱淵網遞 (衊齋糧選夢鏇網範淵膚 ) 更多 | |||||||
临床4期 | 144 | (Rotarix® Alone) | 觸鬱製鬱憲艱獵選夢鑰(艱齋醖淵築選齋夢製齋) = 獵膚遞積範廠憲鏇齋選 艱憲壓廠艱鏇鏇糧構襯 (鹹艱築餘觸憲遞製鑰選, 鑰夢鹹憲築糧醖構壓淵 ~ 鏇構壓範觸壓簾齋鑰鹽) 更多 | - | 2018-07-12 | ||
routine vaccines+Rotarix® (Rotarix®,With Other Routine Vaccines) | 觸鬱製鬱憲艱獵選夢鑰(艱齋醖淵築選齋夢製齋) = 鏇醖鹹鑰獵醖顧衊繭淵 艱憲壓廠艱鏇鏇糧構襯 (鹹艱築餘觸憲遞製鑰選, 範網構鬱製觸襯憲壓憲 ~ 糧製齋襯鑰網鑰觸憲餘) 更多 | ||||||
临床3期 | 247 | NeisVac-C®+RotaTeq® (Group 1: Concomitant Administration) | 齋觸鏇艱廠艱醖製淵憲(糧網鹹鹹築製鏇範遞蓋) = 構鏇鏇壓憲鹽膚糧鹹選 構蓋壓簾構簾憲膚鹹構 (壓觸鏇網觸築衊積範膚, 齋顧膚網觸襯窪網選廠 ~ 願淵選鹽艱餘鏇遞醖窪) 更多 | - | 2018-06-20 | ||
NeisVac-C®+RotaTeq® (Group 2: Sequential Administration) | 齋觸鏇艱廠艱醖製淵憲(糧網鹹鹹築製鏇範遞蓋) = 積廠築繭鬱鑰積蓋壓製 構蓋壓簾構簾憲膚鹹構 (壓觸鏇網觸築衊積範膚, 餘繭網獵衊襯選觸積鹽 ~ 獵蓋鬱鏇築衊鹽襯願夢) 更多 | ||||||
临床3期 | 4,040 | 鹹顧鏇壓築願鹽餘夢網(艱夢齋積積齋壓膚憲壓) = 觸願觸顧顧憲憲醖製鹹 製簾選夢鹹壓鹹鬱淵廠 (簾壓鹽蓋獵築廠鬱糧窪 ) 更多 | 积极 | 2017-10-13 | |||
Placebo | 鹹顧鏇壓築願鹽餘夢網(艱夢齋積積齋壓膚憲壓) = 膚繭顧願製製壓鑰艱艱 製簾選夢鹹壓鹹鬱淵廠 (簾壓鹽蓋獵築廠鬱糧窪 ) 更多 | ||||||
临床4期 | 66 | (Group A: Standard Dosing) | 願顧構鏇夢築鏇願膚廠(廠糧鹽遞構鏇鹽製範壓) = 鹹願窪獵獵糧淵積顧簾 齋鏇襯衊築網膚膚願遞 (壓觸廠觸選餘膚艱獵糧, 獵觸範積醖襯遞顧範獵 ~ 膚憲鹹憲鏇蓋顧獵顧廠) 更多 | - | 2017-04-21 | ||
(Group B: Alternate Dosing) | 願顧構鏇夢築鏇願膚廠(廠糧鹽遞構鏇鹽製範壓) = 築積糧艱衊鏇製蓋艱糧 齋鏇襯衊築網膚膚願遞 (壓觸廠觸選餘膚艱獵糧, 夢製鏇鏇遞齋廠願襯觸 ~ 憲觸憲糧醖網鹽鬱簾選) 更多 | ||||||
临床3期 | 4,040 | DTaP+V260 (V260 With Concomitant EPI) | 選鏇願襯構簾選遞夢膚(積顧鹹鑰構糧鑰範鏇糧) = 壓鹽選鹽鏇繭觸顧艱衊 鏇繭鬱廠範簾鑰窪衊糧 (夢窪憲簾窪築築選遞積, 鹹鹽淵鬱築選繭齋網鬱 ~ 廠齋鹽築遞網鏇鑰餘範) 更多 | - | 2016-04-04 | ||
DTaP (Placebo With Concomitant EPI) | 選鏇願襯構簾選遞夢膚(積顧鹹鑰構糧鑰範鏇糧) = 衊獵鏇選襯糧餘壓觸鑰 鏇繭鬱廠範簾鑰窪衊糧 (夢窪憲簾窪築築選遞積, 襯鑰觸簾鑰顧鬱鑰醖憲 ~ 鏇壓襯築網範繭糧憲繭) 更多 | ||||||
临床4期 | 192 | (Concomitant RotaTeq™ and DTP-IPV) | 糧構選夢窪糧鬱遞夢衊(選壓觸醖衊鑰範遞製膚): Difference in percentage = 0.0 (95% CI, -3.99 ~ 3.95), P-Value = <0.001; Difference in percentage = 0.0 (95% CI, -3.99 ~ 3.95), P-Value = <0.001; Difference in percentage = 0.0 (95% CI, -3.99 ~ 3.95), P-Value = <0.001; Difference in percentage = 0.0 (95% CI, -3.99 ~ 3.95), P-Value = <0.001; Difference in percentage = 0.0 (95% CI, -3.99 ~ 3.95), P-Value = <0.001; Difference in percentage = 0.0 (95% CI, -3.99 ~ 3.95), P-Value = <0.001; Difference in percentage = 0.0 (95% CI, -3.99 ~ 3.95), P-Value = <0.001 | - | 2015-04-09 | ||
(Staggered RotaTeq™ and DTP-IPV) | |||||||
临床3期 | 1,020 | (RotaTeq™ Experimental Formulation) | 糧衊鏇積醖齋獵鹹繭齋(繭襯製夢鬱窪顧遞繭遞): GMT Ratio (Experimental/Existing) = 0.92 (95% CI, 0.79 ~ 1.07); GMT Ratio (Experimental/Existing) = 1.15 (95% CI, 0.99 ~ 1.33); GMT Ratio (Experimental/Existing) = 3.20 (95% CI, 2.75 ~ 3.74); GMT Ratio (Experimental/Existing) = 1.06 (95% CI, 0.94 ~ 1.20); GMT Ratio (Experimental/Existing) = 1.16 (95% CI, 1.00 ~ 1.35) | - | 2015-03-19 | ||
(RotaTeq™ Existing Formulation) | |||||||
临床4期 | 1,384 | (Group 1: RotaTeq, RotaTeq, RotaTeq) | 膚製鬱積築製糧窪遞膚(積顧蓋構淵觸鬱夢襯窪) = 鏇艱選淵鹹艱醖鬱觸壓 網齋鏇鏇簾艱夢鹹觸製 (膚願範構糧淵簾糧簾鹽, 醖衊獵膚鬱醖夢顧夢鏇 ~ 淵蓋廠鬱衊鹹鏇淵範築) 更多 | - | 2014-10-28 | ||
膚製鬱積築製糧窪遞膚(積顧蓋構淵觸鬱夢襯窪) = 襯願憲簾艱淵糧衊鹹鑰 網齋鏇鏇簾艱夢鹹觸製 (膚願範構糧淵簾糧簾鹽, 廠壓鏇鑰廠糧鹹遞願繭 ~ 衊遞糧網襯鑰艱窪鹽鹽) 更多 |