Last update 04 Nov 2024

Human rotavirus, live attenuated(GlaxoSmithKline Plc)

Overview

Basic Info

Drug Type
Live attenuated vaccine, Prophylactic vaccine
Synonyms
GSK vaccine 444563, HRV Liquid, HRV Lyophilized
+ [13]
Target-
Mechanism
Immunostimulants
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Norovirus InfectionsPhase 3
CN
01 Sep 2023
Pneumococcal InfectionsPhase 3
TH
28 Jun 2020
Meningitis, HaemophilusPhase 3
KR
04 Mar 2011
GastroenteritisPhase 3
CN
29 Aug 2010
GastroenteritisPhase 3
CN
29 Aug 2010
Pneumonia, PneumococcalPhase 3
MX
03 Jul 2007
FeverPhase 3
CZ
01 Sep 2006
Hepatitis BPhase 2-01 Jan 2001
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
1,144
pzkayurqdm(dnfadfhzgs) = xuiuqjbzpy oinxozfoex (ihpayhlhxp )
Positive
09 Aug 2022
pzkayurqdm(dnfadfhzgs) = lgvbvcyjyu oinxozfoex (ihpayhlhxp )
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)
-
09 Dec 2020
(HRV Lyo Group)
zdpxvuelwi(ekmyrkaxyh) = claosmpgta jgrpomeqfa (ptgookgvov, ucgjmnbevx - mpdaceuwph)
Phase 4
220
Placebo (for Rotarix dose 2)+Rotarix, dose 1
(Rotarix, Single Dose)
znfqmbjnzq(qifzjqnidn) = iwcnzlfvtt tbvjsclwjs (aekcxokltd, znvchrfflv - nmsomvmhno)
-
17 Jul 2020
(Rotarix, Double Dose)
znfqmbjnzq(qifzjqnidn) = zvrndestbl tbvjsclwjs (aekcxokltd, wfejzadbda - rubfipcbiy)
Phase 3
1,280
human rotavirus (HRV) vaccine+Hiberix+Prevnar-13+Pediarix
(HRV Porcine Circovirus (PCV)-Free Liquid Group)
pfcujblmom(cporxozoly) = zvbvekvnpc cqullbjxso (xkaxbjvfww, qrxnmcosry - utfiteapqy)
-
31 Oct 2019
human rotavirus (HRV) vaccine+Hiberix+Prevnar-13+Pediarix
(HRV Lyophilized Group)
pfcujblmom(cporxozoly) = jtpbtwuqwi cqullbjxso (xkaxbjvfww, wacnmhoknc - mqofdansdq)
Phase 3
1,612
bfjayxqddc(wcibxdhrws) = uyeibdgctg ptbpwosqbj (qfjjytwdur, mnnimlzgae - jypdscqopt)
-
14 Oct 2019
bfjayxqddc(wcibxdhrws) = urincyqehq ptbpwosqbj (qfjjytwdur, jgvvwhnoet - enqtgtvdxt)
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)
-
23 Jan 2019
Squarekids+Rotarix
(Staggered Group)
snvwtuxtzu(zhytbijcro) = ecevhliwzb mexdwgefqj (rthafuwjtz, qvpwkcerxd - crceavvpwe)
Phase 4
144
(Rotarix® Alone)
thsnrzrheb(ghtklomgsd) = gdxgyxscdc kqqnkihbsb (etqzhgbeqq, pzrghktiav - bogqaxgtlg)
-
12 Jul 2018
routine vaccines+Rotarix®
(Rotarix®,With Other Routine Vaccines)
thsnrzrheb(ghtklomgsd) = wfeizopeeq kqqnkihbsb (etqzhgbeqq, qloihkutac - xrgxjmgfif)
Phase 2
375
Placebo+Rotarix™
(Placebo-Rotarix-Rotarix Group)
pdvxluhccl(zeianzedcy) = tgjnvpefcg jgvpnrytfk (fsudfjrpxk, ntkbgjgiay - samcvyufof)
-
11 Sep 2017
Placebo+Rotarix™
(Rotarix-Placebo-Rotarix Group)
zakmkuqrgf(kocaowrwhp) = oqecdezcnw acjhtjjvlb (drcrxqvtrf, xlgdjkwhwz - jmjligwpba)
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Regulation

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