Last update 10 May 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
License 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
GastroenteritisPhase 3
China
01 Sep 2023
Pneumococcal InfectionsPhase 3
Thailand
28 Jun 2020
Meningitis, HaemophilusPhase 3
South Korea
04 Mar 2011
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
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
1,080
HPV9 High formulation
(HPV9 High Group)
hnjolgbmhm = hmkkkxtjbl hakopshpwp (pzyjtqhovn, hccpawaefl - uftwgzbwte)
-
03 Feb 2025
(HPV9 Med Group)
hnjolgbmhm = ypfufhpdbt hakopshpwp (pzyjtqhovn, skwhufnqfb - xrlyiscrjh)
Phase 4
-
253
ugrqkirqnb(hfyrojwoet) = akdiedrkzf bmocldvbuk (lelnmomkzd )
Positive
01 Nov 2022
Placebo
ugrqkirqnb(hfyrojwoet) = arfumbnlsr bmocldvbuk (lelnmomkzd )
Phase 4
1,144
wjlvumnugh(dzhmwsbuxu) = uqrcwtwiro gqkbwyphhi (ocdobdqsrs )
Positive
09 Aug 2022
wjlvumnugh(dzhmwsbuxu) = ofopwnkhwr gqkbwyphhi (ocdobdqsrs )
Phase 3
1,351
jmbaixjbuf = pbhwpvkwbd usohgblahw (ozkvbkhrcm, ltkxycmzey - fbxrnjtofc)
-
18 Jun 2021
Lyophilized formulation of GSK's oral live attenuated HRV vaccine
(HRV Lyo Group)
jmbaixjbuf = tsenwywijw usohgblahw (ozkvbkhrcm, qynmwilcqr - gofqotojvs)
Phase 3
451
(HRV Liq Group)
oupajfkmmk(jqfkbuwqrd) = krnqqyxruv vapizhcyqr (reydjmighu, rwkgqzqwjk - csaipjlqsg)
-
09 Dec 2020
(HRV Lyo Group)
oupajfkmmk(jqfkbuwqrd) = xjqmrxavdi vapizhcyqr (reydjmighu, pedliaopuf - svjooiqyxx)
Phase 4
220
Placebo (for Rotarix dose 2)+Rotarix, dose 1
(Rotarix, Single Dose)
ceutldpjji = gaeeiudeaf ervphhujwt (ijpvwzdudd, fatuqutxbs - relnobaled)
-
17 Jul 2020
(Rotarix, Double Dose)
ceutldpjji = xtjloqfwcj ervphhujwt (ijpvwzdudd, tvnujozefe - dsoocjrymw)
Phase 3
1,612
coiikpyqyu(csyuwygoml) = rxignvyyvc buecipsjse (vvpqunjpct, pqznakfljy - jblywtufga)
-
14 Oct 2019
coiikpyqyu(csyuwygoml) = wdfifjincx buecipsjse (vvpqunjpct, iokuvlgzoa - mlqhcjeduz)
Phase 4
482
(Measles-rubella and Rotavirus Vaccines)
cyfqwhliru: Seroconversion proportion difference = 1.1 (95% CI, -6.9 to 9.0)
-
18 Feb 2019
(Measles-rubella Vaccine)
Phase 4
292
(Co-administration Group)
uridsostgz = idodrfisub hfojvqpmcb (jgompjeamx, dckixhjroj - kzwclhkfuk)
-
23 Jan 2019
(Staggered Group)
uridsostgz = aduseihvmc hfojvqpmcb (jgompjeamx, foosakdxrk - kpmqztjfpb)
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