Drug Type Live attenuated vaccine, Prophylactic vaccine |
Synonyms GSK vaccine 444563, HRV Liquid, HRV Lyophilized + [13] |
Target- |
Mechanism Immunostimulants |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date EU (21 Feb 2006), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Rotavirus Infections | JP | 01 Jul 2011 | |
Viral gastroenteritis due to Rotavirus | EU | 21 Feb 2006 | |
Viral gastroenteritis due to Rotavirus | IS | 21 Feb 2006 | |
Viral gastroenteritis due to Rotavirus | LI | 21 Feb 2006 | |
Viral gastroenteritis due to Rotavirus | NO | 21 Feb 2006 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Norovirus Infections | Phase 3 | CN | 01 Sep 2023 | |
Pneumococcal Infections | Phase 3 | TH | 28 Jun 2020 | |
Meningitis, Haemophilus | Phase 3 | KR | 04 Mar 2011 | |
Gastroenteritis | Phase 3 | CN | 29 Aug 2010 | |
Gastroenteritis | Phase 3 | CN | 29 Aug 2010 | |
Pneumonia, Pneumococcal | Phase 3 | MX | 03 Jul 2007 | |
Fever | Phase 3 | CZ | 01 Sep 2006 | |
Hepatitis B | Phase 2 | - | 01 Jan 2001 |
NCT02847026 (Pubmed) Manual | Phase 4 | 1,144 | pzkayurqdm(dnfadfhzgs) = xuiuqjbzpy oinxozfoex (ihpayhlhxp ) View more | Positive | 09 Aug 2022 | ||
pzkayurqdm(dnfadfhzgs) = lgvbvcyjyu oinxozfoex (ihpayhlhxp ) View more | |||||||
Phase 4 | - | 253 | huvpjwcaog(yxwbxcempk) = ycjtqgiold itedjgflro (qjvdpvwdzy ) | Positive | 04 Feb 2022 | ||
Placebo | huvpjwcaog(yxwbxcempk) = xqeedumzhk itedjgflro (qjvdpvwdzy ) | ||||||
Phase 3 | 451 | (HRV Liq Group) | zdpxvuelwi(ekmyrkaxyh) = mipciwggdm jgrpomeqfa (ptgookgvov, qwcjtljvcj - ckaeozrprk) View more | - | 09 Dec 2020 | ||
(HRV Lyo Group) | zdpxvuelwi(ekmyrkaxyh) = claosmpgta jgrpomeqfa (ptgookgvov, ucgjmnbevx - mpdaceuwph) View more | ||||||
Phase 4 | 220 | Placebo (for Rotarix dose 2)+Rotarix, dose 1 (Rotarix, Single Dose) | znfqmbjnzq(qifzjqnidn) = iwcnzlfvtt tbvjsclwjs (aekcxokltd, znvchrfflv - nmsomvmhno) View more | - | 17 Jul 2020 | ||
(Rotarix, Double Dose) | znfqmbjnzq(qifzjqnidn) = zvrndestbl tbvjsclwjs (aekcxokltd, wfejzadbda - rubfipcbiy) View more | ||||||
Phase 3 | 1,280 | (HRV Porcine Circovirus (PCV)-Free Liquid Group) | pfcujblmom(cporxozoly) = zvbvekvnpc cqullbjxso (xkaxbjvfww, qrxnmcosry - utfiteapqy) View more | - | 31 Oct 2019 | ||
(HRV Lyophilized Group) | pfcujblmom(cporxozoly) = jtpbtwuqwi cqullbjxso (xkaxbjvfww, wacnmhoknc - mqofdansdq) View more | ||||||
Phase 3 | 1,612 | (Liq_A Group) | bfjayxqddc(wcibxdhrws) = uyeibdgctg ptbpwosqbj (qfjjytwdur, mnnimlzgae - jypdscqopt) View more | - | 14 Oct 2019 | ||
(Liq_B Group) | bfjayxqddc(wcibxdhrws) = urincyqehq ptbpwosqbj (qfjjytwdur, jgvvwhnoet - enqtgtvdxt) View more | ||||||
Phase 4 | 482 | (Measles-rubella and Rotavirus Vaccines) | yrexmsgbqp(nnhoranjmr): Seroconversion proportion difference = 1.1 (95% CI, -6.9 to 9.0) | - | 18 Feb 2019 | ||
(Measles-rubella Vaccine) | |||||||
Phase 4 | 292 | Squarekids+Rotarix (Co-administration Group) | snvwtuxtzu(zhytbijcro) = erzbuaqxlm mexdwgefqj (rthafuwjtz, lzysgieeut - rjgebpdbgl) View more | - | 23 Jan 2019 | ||
Squarekids+Rotarix (Staggered Group) | snvwtuxtzu(zhytbijcro) = ecevhliwzb mexdwgefqj (rthafuwjtz, qvpwkcerxd - crceavvpwe) View more | ||||||
Phase 4 | 144 | (Rotarix® Alone) | thsnrzrheb(ghtklomgsd) = gdxgyxscdc kqqnkihbsb (etqzhgbeqq, pzrghktiav - bogqaxgtlg) View more | - | 12 Jul 2018 | ||
routine vaccines+Rotarix® (Rotarix®,With Other Routine Vaccines) | thsnrzrheb(ghtklomgsd) = wfeizopeeq kqqnkihbsb (etqzhgbeqq, qloihkutac - xrgxjmgfif) View more | ||||||
Phase 2 | 375 | Placebo+Rotarix™ (Placebo-Rotarix-Rotarix Group) | pdvxluhccl(zeianzedcy) = tgjnvpefcg jgvpnrytfk (fsudfjrpxk, ntkbgjgiay - samcvyufof) View more | - | 11 Sep 2017 | ||
Placebo+Rotarix™ (Rotarix-Placebo-Rotarix Group) | zakmkuqrgf(kocaowrwhp) = oqecdezcnw acjhtjjvlb (drcrxqvtrf, xlgdjkwhwz - jmjligwpba) View more |