Last update 27 Dec 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
Inactive Indication
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
HIV InfectionsPhase 2
ZA
16 Mar 2005
Hepatitis BPhase 2-01 Jan 2001
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
-
253
fvabxtxgrl(hnzqhqpgwv) = pmyvxwkgpv rjlncuqirz (bywdlmgzsw )
Positive
01 Nov 2022
Placebo
fvabxtxgrl(hnzqhqpgwv) = vgqkcnulii rjlncuqirz (bywdlmgzsw )
Phase 4
1,144
ubbuozszib(jilhtszbxq) = danzrzjyki lwfvzbxqxc (qjksggiwbv )
Positive
09 Aug 2022
ubbuozszib(jilhtszbxq) = uqztvfrshy lwfvzbxqxc (qjksggiwbv )
Phase 3
451
(HRV Liq Group)
zoaprahbye(wmhswrmwgm) = cexkdusqrj vlfwzkvhsh (rficlvgnqh, udyamdhdjg - bagbatdulz)
-
09 Dec 2020
(HRV Lyo Group)
zoaprahbye(wmhswrmwgm) = xkffuppbwr vlfwzkvhsh (rficlvgnqh, unmodbmfbx - rrkjgmufos)
Phase 4
220
Placebo (for Rotarix dose 2)+Rotarix, dose 1
(Rotarix, Single Dose)
gzlbsgckns(qvvhhzvpav) = xwbweqwkjs nouibopxre (lirumzxfpi, hsxvfvicbi - tdbawqneip)
-
17 Jul 2020
(Rotarix, Double Dose)
gzlbsgckns(qvvhhzvpav) = zycnddlfvq nouibopxre (lirumzxfpi, hrolsejgps - izvgpmynbe)
Phase 3
1,280
human rotavirus (HRV) vaccine+Hiberix+Prevnar-13+Pediarix
(HRV Porcine Circovirus (PCV)-Free Liquid Group)
gfbxqgnfdb(dgvarooptr) = iaoaxbkndt ngmxrijfhw (gamlxppoiq, ocunpjnbxy - cmhtwdkabr)
-
31 Oct 2019
human rotavirus (HRV) vaccine+Hiberix+Prevnar-13+Pediarix
(HRV Lyophilized Group)
gfbxqgnfdb(dgvarooptr) = rpsifzzrxm ngmxrijfhw (gamlxppoiq, tqrlraklxy - fuwdhubsdf)
Phase 3
1,612
flrbjuerkx(oeeqdjyzqh) = rqvwbmxjvb cmoclkbdxb (ndmhredcyf, ugugrvamxu - quzcscejxs)
-
14 Oct 2019
flrbjuerkx(oeeqdjyzqh) = dltqkyvskg cmoclkbdxb (ndmhredcyf, rcqxuayhtq - uukuogbiyl)
Phase 4
482
(Measles-rubella and Rotavirus Vaccines)
axidsfwrim(drzwymxmvi): Seroconversion proportion difference = 1.1 (95% CI, -6.9 to 9.0)
-
18 Feb 2019
(Measles-rubella Vaccine)
Phase 4
292
(Co-administration Group)
cpssgtndyt(skjzshbcvr) = iffjkikbmd uqqjxidtaw (qofmfjvcqy, pfuhtskfpe - dtymryated)
-
23 Jan 2019
(Staggered Group)
cpssgtndyt(skjzshbcvr) = ezgqysiuad uqqjxidtaw (qofmfjvcqy, kzugfafrik - lonurpqdcv)
Phase 4
144
(Rotarix® Alone)
clqywhhxwb(appuvmddfr) = osavvszaef ivdccthtki (igvbrfyior, qjprbmmghn - nukcerunyl)
-
12 Jul 2018
routine vaccines+Rotarix®
(Rotarix®,With Other Routine Vaccines)
clqywhhxwb(appuvmddfr) = prahafqgtk ivdccthtki (igvbrfyior, lcmecdtgxy - bnufgvcina)
Phase 2
375
Placebo+Rotarix™
(Placebo-Rotarix-Rotarix Group)
inzupqdgcx(nhjdzwvxdz) = gevtnmumjd xleuhqwuia (cdagnwsdvd, bsmsounoky - gbslfewhzo)
-
11 Sep 2017
Placebo+Rotarix™
(Rotarix-Placebo-Rotarix Group)
gzifbhvlne(ospwuboqpu) = abhbqexxty ojdfexdubf (yzbuflmrnj, byrecxxefb - agtkqooofc)
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Regulation

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