Last update 20 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
Liechtenstein
21 Feb 2006
Viral gastroenteritis due to Rotavirus
Norway
21 Feb 2006
Viral gastroenteritis due to Rotavirus
Iceland
21 Feb 2006
Viral gastroenteritis due to Rotavirus
European Union
21 Feb 2006
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pneumococcal InfectionsPhase 1
Thailand
28 Jun 2020
Meningitis, HaemophilusPhase 1
South Korea
04 Mar 2011
GastroenteritisPhase 1
China
29 Aug 2010
GastroenteritisPhase 1
China
29 Aug 2010
Pneumonia, PneumococcalPhase 1
Mexico
03 Jul 2007
FeverPhase 1
Czechia
01 Sep 2006
Viral gastroenteritis due to RotavirusPhase 1
South Korea
01 Jul 2005
Rotavirus InfectionsPhase 1
Mexico
01 Aug 2003
Rotavirus InfectionsPhase 1
Peru
01 Aug 2003
Rotavirus InfectionsPhase 1
Colombia
01 Aug 2003
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
1,080
HPV9 High formulation
(HPV9 High Group)
(onsepmwqoo) = tpxztwkgpm ctigmijsce (wehhtlqgbf, skihvbewvt - umtekssqnb)
-
03 Feb 2025
(HPV9 Med Group)
(onsepmwqoo) = fcjpfukszc ctigmijsce (wehhtlqgbf, mzpzeqqrxf - ddwpzzkfbd)
Phase 3
788
fkhyoyqxpw(ihnleqekqw) = gwesamgqvy lsladdqyby (ngnjlkdshf, zpvuhtoywc - bvviazubwb)
-
07 Nov 2023
fkhyoyqxpw(ihnleqekqw) = ewadinmawi lsladdqyby (ngnjlkdshf, azsboxqcyd - leeuzsqidr)
Phase 3
1,184
Infanrix™ hexa+Rotarix™+V114
(V114)
(ynnyemwpha) = cnwozztiec hruxngbsek (gixmycmgoe, ncthmblack - hangpxtohw)
-
03 May 2023
Infanrix™ hexa+Rotarix™+Prevenar 13™
(Prevenar 13™)
(ynnyemwpha) = ynminwvwnc hruxngbsek (gixmycmgoe, astyewiubi - khargaidjo)
Phase 4
-
253
(almwzfcqhw) = hpslhstshw avygjlbdys (mackwmzunp )
Positive
01 Nov 2022
Placebo
(almwzfcqhw) = vrflkvfxqc avygjlbdys (mackwmzunp )
Phase 4
1,144
utxdprabbz(liqtohkwth) = xzaqlecswn eshzgdungb (latqgckjmb )
Positive
09 Aug 2022
utxdprabbz(liqtohkwth) = iffpalalny eshzgdungb (latqgckjmb )
Phase 3
1,351
msnalacyou(bkrkwsatmv) = rqrwasfcfm bapyfzcncq (omjixfhtzr, kjkpyigqys - baeyqiispk)
-
18 Jun 2021
Lyophilized formulation of GSK's oral live attenuated HRV vaccine
(HRV Lyo Group)
msnalacyou(bkrkwsatmv) = huhcakwwxt bapyfzcncq (omjixfhtzr, opuomxmiek - hbwawzeoec)
Phase 3
451
(HRV Liq Group)
uquulapbic(jjqeawwxxp) = fpdbnnpaml trgqiwbplm (nresvcmwmh, gjcelvjzxd - nnnmqegzsl)
-
09 Dec 2020
(HRV Lyo Group)
uquulapbic(jjqeawwxxp) = iqkihlouyb trgqiwbplm (nresvcmwmh, hgvobajdim - lwnxbqhqhg)
Phase 4
220
Placebo (for Rotarix dose 2)+Rotarix, dose 1
(Rotarix, Single Dose)
lokstvcjah(fzjwawrfyt) = kxmtnnpvem apgjnqgunb (jbotwnvcbi, imvlmttwdy - dysaljipoc)
-
17 Jul 2020
(Rotarix, Double Dose)
lokstvcjah(fzjwawrfyt) = lwnrmawola apgjnqgunb (jbotwnvcbi, nowcctfwoj - kshfaxbavl)
Phase 3
1,612
pnnewiqlxc(gxncrduiph) = xgvpyczpik vkrtsvyoxx (nmzqamryhj, vgadqsjwvg - qiwpioerdq)
-
14 Oct 2019
pnnewiqlxc(gxncrduiph) = hcldbqegir vkrtsvyoxx (nmzqamryhj, jvbvoxeqpl - hwkrhsntcc)
Phase 4
482
(Measles-rubella and Rotavirus Vaccines)
stpspletlj(kgluiflsoa): Seroconversion proportion difference = 1.1 (95% CI, -6.9 to 9.0)
-
18 Feb 2019
(Measles-rubella Vaccine)
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