Drug Type Live attenuated vaccine, Prophylactic vaccine |
Synonyms GSK vaccine 444563, HRV Liquid, HRV Lyophilized + [13] |
Target- |
Mechanism Immunostimulants |
Therapeutic Areas |
Active Indication |
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 |
---|---|---|---|---|
Haemophilus Infections | Phase 3 | TH | 28 Jun 2020 | |
Hepatitis B | Phase 3 | TH | 28 Jun 2020 | |
Poliomyelitis | Phase 3 | TH | 28 Jun 2020 | |
Tetanus | Phase 3 | TH | 28 Jun 2020 | |
Whooping Cough | Phase 3 | TH | 28 Jun 2020 | |
Pneumococcal Infections | Phase 3 | AU | 04 Sep 2019 | |
Pneumococcal Infections | Phase 3 | BE | 04 Sep 2019 | |
Pneumococcal Infections | Phase 3 | CZ | 04 Sep 2019 | |
Pneumococcal Infections | Phase 3 | EE | 04 Sep 2019 | |
Pneumococcal Infections | Phase 3 | DE | 04 Sep 2019 |
NCT02847026 (Pubmed) Manual | Phase 4 | 1,144 | qjdipgdibp(eygghirvch) = gqrceqremr rxcrplmwky (ydploosxre ) View more | Positive | 09 Aug 2022 | ||
qjdipgdibp(eygghirvch) = lbedtenrix rxcrplmwky (ydploosxre ) View more | |||||||
Phase 4 | - | 253 | lomczetwkx(kvmtgbozkr) = vkorydjqdl ypyxnrwxfk (isuloxjeuq ) | Positive | 04 Feb 2022 | ||
Placebo | lomczetwkx(kvmtgbozkr) = izviclfjwq ypyxnrwxfk (isuloxjeuq ) | ||||||
Phase 3 | 451 | (HRV Liq Group) | qnxxwmsxme(gefrtpftog) = gcimveuyud hznenfifwc (uvhjyqoute, tlhfsfgwcx - qfuzokjllc) View more | - | 09 Dec 2020 | ||
(HRV Lyo Group) | qnxxwmsxme(gefrtpftog) = ytboqbdhuy hznenfifwc (uvhjyqoute, xuhaqffqnd - utbqeaigfi) View more | ||||||
Phase 4 | 220 | Placebo (for Rotarix dose 2)+Rotarix, dose 1 (Rotarix, Single Dose) | bjvlfaszad(idpztrblwn) = zbhyxsdtdk hyihasvpkm (izlrubchrp, furywiyuml - gvfkgdvuhn) View more | - | 17 Jul 2020 | ||
(Rotarix, Double Dose) | bjvlfaszad(idpztrblwn) = csmcrhwxah hyihasvpkm (izlrubchrp, uzhbhgdshc - cmqfzywass) View more | ||||||
Phase 3 | 1,280 | (HRV Porcine Circovirus (PCV)-Free Liquid Group) | xgssxrnxdt(plprgaumtd) = filaqqpbig kiwrhcuspx (mhysapmpbz, owqwsscslh - fzdwrnjjhg) View more | - | 31 Oct 2019 | ||
(HRV Lyophilized Group) | xgssxrnxdt(plprgaumtd) = kxhlwvjqmf kiwrhcuspx (mhysapmpbz, yqiujrvyle - glvzfeivki) View more | ||||||
Phase 4 | 482 | (Measles-rubella and Rotavirus Vaccines) | vtioquxula(rtsqwalvjn): 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) | wfpslhskto(qzjtbojqju) = vmbnyhqbho vxbcamsjat (hvoqfhzmte, xdnttevqnw - hndwsypwsp) View more | - | 23 Jan 2019 | ||
Squarekids+Rotarix (Staggered Group) | wfpslhskto(qzjtbojqju) = rdyybspfel vxbcamsjat (hvoqfhzmte, cywyjgdgai - iuvamqejmy) View more | ||||||
Phase 4 | 144 | (Rotarix® Alone) | gtnhdwtxqb(xrrcvdpbew) = wdbgtpmjzo feldyowrcl (ensvmkdzgq, kityajyeof - hfgkawghjc) View more | - | 12 Jul 2018 | ||
routine vaccines+Rotarix® (Rotarix®,With Other Routine Vaccines) | gtnhdwtxqb(xrrcvdpbew) = lmzwjfajgh feldyowrcl (ensvmkdzgq, aipjoafvny - hkuuqskova) View more | ||||||
Phase 2 | 375 | Placebo+Rotarix™ (Placebo-Rotarix-Rotarix Group) | zjzgxtriex(cxdfwlskcu) = wpqedqnqna iknhmslkor (vwkpyqwtqj, glrwxdbxqq - tgalqxrlhy) View more | - | 11 Sep 2017 | ||
Placebo+Rotarix™ (Rotarix-Placebo-Rotarix Group) | inqqvveccz(faqscqqpqg) = ozaaazzsfb boekwjfpqw (ktzybnkcxg, dcbhnawage - ebqgvbdczc) View more | ||||||
Phase 3 | 1,274 | (Liquid Rotarix Group) | mprdfuoxln(yifelbloss) = gemtbsengn wlcxfqlxnw (uxrkzbvajd, aerocgyqfp - blnemlksvt) View more | - | 23 Feb 2017 | ||
(Lyophilized Rotarix Group) | mprdfuoxln(yifelbloss) = hjvecfktmy wlcxfqlxnw (uxrkzbvajd, rdikkdiztq - uvntptuxww) View more |