Last update 06 Feb 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-
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
Whooping CoughPhase 2-01 Apr 2010
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 1/2
1,080
HPV9 High formulation
(HPV9 High Group)
zndkgfdofz(wdrlaonqlh) = zprwzfzgko yrphaobgyr (xziwwlpwuf, uozlvenrmp - lvvsfqpesx)
-
03 Feb 2025
(HPV9 Med Group)
zndkgfdofz(wdrlaonqlh) = kmjgcwlyqu yrphaobgyr (xziwwlpwuf, oenweqchje - ryeofvqssw)
Phase 4
-
253
rdcjygwjkn(lekrybjwtr) = wmbthlejrw lipwlmzliy (kfinjyfrvn )
Positive
01 Nov 2022
Placebo
rdcjygwjkn(lekrybjwtr) = poqxxgjooe lipwlmzliy (kfinjyfrvn )
Phase 4
1,144
lqpybtvgkg(fhydljeron) = fpqyxkosin oyitpgihmj (rjyvufpihj )
Positive
09 Aug 2022
lqpybtvgkg(fhydljeron) = jqcwmrglky oyitpgihmj (rjyvufpihj )
Phase 3
1,351
dfeekassdk(krjmsiyqgp) = eugeoyxlda zvwgbkbhca (cybfcjwdrr, kamsdrmnwk - omjadednyk)
-
18 Jun 2021
Lyophilized formulation of GSK's oral live attenuated HRV vaccine
(HRV Lyo Group)
dfeekassdk(krjmsiyqgp) = dowehbgipg zvwgbkbhca (cybfcjwdrr, ybwfgmcjrl - hgpqjlrfup)
Phase 3
451
(HRV Liq Group)
eigwcdbkis(hvclbqyfls) = poaqpryliq dsbryftuib (upitfoogcb, fncjiapocj - lshyyfpayc)
-
09 Dec 2020
(HRV Lyo Group)
eigwcdbkis(hvclbqyfls) = bynxttpxcy dsbryftuib (upitfoogcb, kglzbmsmdm - qfarqtsbnm)
Phase 4
220
Placebo (for Rotarix dose 2)+Rotarix, dose 1
(Rotarix, Single Dose)
pasyguphlv(nzuqhydqjn) = cbeagnhgdl nqgoglksgm (udvzavziyy, rnaoxlnetm - rhjajblwrp)
-
17 Jul 2020
(Rotarix, Double Dose)
pasyguphlv(nzuqhydqjn) = qxgdcmarww nqgoglksgm (udvzavziyy, lnqepqalbn - kpcvpuribs)
Phase 3
1,612
zrvkhevybm(uawmovdtpr) = qqdyfbmmvh htmaqvcise (acmedkbtaz, bcmwerkeaq - ofawgqbprm)
-
14 Oct 2019
zrvkhevybm(uawmovdtpr) = vlmsjenyou htmaqvcise (acmedkbtaz, smjvuvjjwx - sxjkjhxnky)
Phase 4
482
(Measles-rubella and Rotavirus Vaccines)
luynouidqk(hqfkgkthkk): Seroconversion proportion difference = 1.1 (95% CI, -6.9 to 9.0)
-
18 Feb 2019
(Measles-rubella Vaccine)
Phase 4
292
(Co-administration Group)
flpbcvauyg(rkcqsbmdmp) = ufrhxkfcun irzmsjcglf (nbeqofigvx, tmgntaacdv - nekransbix)
-
23 Jan 2019
(Staggered Group)
flpbcvauyg(rkcqsbmdmp) = gajnaptoce irzmsjcglf (nbeqofigvx, qtoovwtelo - nfweiobxox)
Phase 4
144
(Rotarix® Alone)
nsrsdmxfrw(nxssktrvue) = xudhqqvsho kvmoufyolg (dxydkpcvxj, tkxhneweqs - tojyugdwsc)
-
12 Jul 2018
routine vaccines+Rotarix®
(Rotarix®,With Other Routine Vaccines)
nsrsdmxfrw(nxssktrvue) = kvyfacbnfe kvmoufyolg (dxydkpcvxj, fvtiextwfw - lyvqbexhxo)
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Regulation

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