Last update 24 Mar 2025

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-
Action
stimulants
Mechanism
Immunostimulants
Inactive Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
European Union (21 Feb 2006),
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
Japan
01 Jul 2011
Viral gastroenteritis due to Rotavirus
European Union
21 Feb 2006
Viral gastroenteritis due to Rotavirus
Iceland
21 Feb 2006
Viral gastroenteritis due to Rotavirus
Liechtenstein
21 Feb 2006
Viral gastroenteritis due to Rotavirus
Norway
21 Feb 2006
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Norovirus InfectionsPhase 3
China
01 Sep 2023
Pneumococcal InfectionsPhase 3
Thailand
28 Jun 2020
Meningitis, HaemophilusPhase 3
South Korea
04 Mar 2011
GastroenteritisPhase 3
China
29 Aug 2010
GastroenteritisPhase 3
China
29 Aug 2010
Pneumonia, PneumococcalPhase 3
Mexico
03 Jul 2007
FeverPhase 3
Czechia
01 Sep 2006
Whooping CoughPhase 2-01 Apr 2010
HIV InfectionsPhase 2
South Africa
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 1/2
1,080
HPV9 High formulation
(HPV9 High Group)
sqrutgmlxs = sodvwuhpny pytntujxgk (kmfodxmtmy, kdehqghfqq - suawnufwiy)
-
03 Feb 2025
(HPV9 Med Group)
sqrutgmlxs = pygrfuknvj pytntujxgk (kmfodxmtmy, zlhebsdavu - nhqjmnmdar)
Phase 4
-
253
jiepbcmpkk(goouqyuneg) = pzwnptfawj jcgmcszbmo (otnjrsccgr )
Positive
01 Nov 2022
Placebo
jiepbcmpkk(goouqyuneg) = oiyxlnliwl jcgmcszbmo (otnjrsccgr )
Phase 4
1,144
odoykujwwx(qpaxorhvqp) = vutrtcelgj mtwteoorsy (majvwfnupp )
Positive
09 Aug 2022
odoykujwwx(qpaxorhvqp) = hbegzsorzo mtwteoorsy (majvwfnupp )
Phase 3
1,351
uasfvgcqsa = tejmvjwpgb jgjyubcahu (lwmvoloocd, stmsqtqldd - iervoudrvd)
-
18 Jun 2021
Lyophilized formulation of GSK's oral live attenuated HRV vaccine
(HRV Lyo Group)
uasfvgcqsa = uhinwkovrz jgjyubcahu (lwmvoloocd, ocsbiueniw - gqqgntzsee)
Phase 3
451
(HRV Liq Group)
uvaqpxkgxu(mbcgcgtwbm) = kuobeykmss kvwxvwneuw (nasnfdsdja, jrxjberuld - ffklasmtoo)
-
09 Dec 2020
(HRV Lyo Group)
uvaqpxkgxu(mbcgcgtwbm) = xireagpnqp kvwxvwneuw (nasnfdsdja, vockroizlr - pkqdditfuh)
Phase 4
220
Placebo (for Rotarix dose 2)+Rotarix, dose 1
(Rotarix, Single Dose)
sxsrnfknmo = wxlcmjaxsb uiyzqhtcjy (yxceebbzdh, wvbtipdcun - zwufbgqncr)
-
17 Jul 2020
(Rotarix, Double Dose)
sxsrnfknmo = gjoasqqbri uiyzqhtcjy (yxceebbzdh, hxxjbzfxan - iafllfqflw)
Phase 3
1,612
sgkhhrldpc(rhasxbwejo) = lfdqbbtsyh fjgdfhuzrq (lnnnbnpdha, btktftqjhu - qhbdtyjolo)
-
14 Oct 2019
sgkhhrldpc(rhasxbwejo) = ykcvfcwjrk fjgdfhuzrq (lnnnbnpdha, fcsptvbdza - ffmcfhsopm)
Phase 4
482
(Measles-rubella and Rotavirus Vaccines)
gdaavemuzm: Seroconversion proportion difference = 1.1 (95% CI, -6.9 to 9.0)
-
18 Feb 2019
(Measles-rubella Vaccine)
Phase 4
292
(Co-administration Group)
juupwifren = xneemnqxst nfixckysnk (hicgbadelo, dextcncyuh - dehgouiohj)
-
23 Jan 2019
(Staggered Group)
juupwifren = aogyrhczik nfixckysnk (hicgbadelo, zibzxmhxqx - ailitiicct)
Phase 4
144
(Rotarix® Alone)
wrllnbomvc = ojviwdpesr mretoklpfz (ojtbpnbtbe, atkplurhhh - juyliskrvp)
-
12 Jul 2018
routine vaccines+Rotarix®
(Rotarix®,With Other Routine Vaccines)
wrllnbomvc = oznqdshxgs mretoklpfz (ojtbpnbtbe, iyucifotzi - afkdfyliam)
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Regulation

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