CDEK
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human rotavirus, live attenuated

Trade name: Rotarix

Vaccineapproved

Approved

Apr 3, 2008

A rotavirus vaccine is a vaccine used to protect against rotavirus infections, which are the leading cause of severe diarrhea among young children. These vaccines prevent 15–34% of severe diarrhea in the developing world and 37–96% of the risk of death among young children due to severe diarrhea. Immunizing babies decreases rates of rotavirus disease among older people and those who have not been immunized. — Wikipedia

Clinical trial activity

94 trials · 62 clinical orgs · 1 marketing orgs

Phase 1
9
Phase 2
67
Phase 3
53
Phase 4
16

Earliest trial started Aug 1, 2000 (NCT00425737)

Timeline

2000s

  1. Jan 1, 2000

    GlaxoSmithKline — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    GlaxoSmithKline — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  4. Apr 3, 2008

    Earliest FDA Approval

2010s

  1. Apr 4, 2018

    GlaxoSmithKline — First NDA Organization

  2. Apr 4, 2018

    GlaxoSmithKline — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

  • RotavirusImmunity, active

    Rotavirus immunity, active

Approval history

  • approvedApr 3, 2008

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • gsk 357941a
  • gsk444563
  • hrv vaccine
  • human rotavirus, live attenuated
  • human rotavirus vaccine
  • live attenuated hrv vaccine
  • live attenuated human rotavirus vaccine
  • live attenuated indian rotavirus vaccine strain 116e
  • live attenuated rotavirus vaccine
  • oral live attenuated human rotavirus vaccine
  • oral rotavirus vaccine
  • oral rotavirus vaccine 116e live attenuated
  • orv 116e
  • rix4414 vaccine
  • rotarix
  • rotarix
  • rotarix
  • rotavac
  • rota virus, live attenuated
  • rotavirus vaccine
  • rotavirus vaccine
  • rotavirus vaccine 444563
  • rotavirus vaccine, live, oral
  • rotavirus vaccine, live, oral
  • rv1 vaccine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06879327Phase 2May 30, 2025PATH, Pharmassist Ltd
NCT06824181Phase 3Feb 27, 2025Sanofi
NCT06824194Phase 3Feb 18, 2025Sanofi
NCT06967272Phase 2Jan 20, 2025China National Pharmaceutical Group
NCT06647407Phase 1/Phase 2 (Phase 2)Oct 28, 2024Sanofi-Aventis
NCT06397768Phase 3May 13, 2024Sanofi-Aventis
NCT06950645Phase 1Mar 27, 2024China National Pharmaceutical Group
NCT06025695Phase 3Sep 1, 2023GlaxoSmithKline
NCT06200844Phase 3Jul 7, 2023Bharat Biotech International Limited
NCT05958771Phase 3Jul 6, 2023Bharat Biotech International Limited, University of Chile
NCT05794230Phase 3Mar 27, 2023Sanofi-Aventis
NCT04658914Phase 2/Phase 3 (Phase 3)Feb 28, 2021Centre for Infectious Disease Research in Zambia (CIDRZ), Institut National de la Santé Et de la Recherche Médicale, France, Medical Research Council, PATH, University of Liverpool
NCT04344054Phase 2Sep 30, 2020Bill and Melinda Gates Foundation, Murdoch University, PATH, SK Bioscience Co., Ltd., University of Cincinnati
NCT04429295Phase 3Jun 29, 2020Sanofi-Aventis
NCT04010448Phase 3Aug 15, 2019Bill and Melinda Gates Foundation, Centre for Infectious Disease Research in Zambia (CIDRZ), PATH, SK Bioscience Co., Ltd., University of Ghana, University of Malawi
NCT04031846Phase 3Aug 9, 2019Merck
NCT03954743Phase 3Jul 19, 2019GlaxoSmithKline
NCT04123119N/AJan 22, 2019Centre for Infectious Disease Research in Zambia (CIDRZ), Christian Medical College, Vellore, India, Imperial College London
NCT03602053Phase 2/Phase 3 (Phase 3)Nov 1, 2018Bharat Biotech International Limited, Centre for Infectious Disease Research in Zambia (CIDRZ), Christian Medical College, Vellore, India, PATH, University of Cincinnati
NCT03673462Phase 3Sep 17, 2018Sanofi-Aventis
Showing 20 of 94 trials
Page 1 / 5

Organizations

Research & Development (62)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit484842000
PATHAcademic/Hospital14742005
Bharat Biotech International LimitedFor profit8522006
Centers for Disease Control and Prevention (CDC)Government6052005
Sanofi-AventisFor profit5522018
Centre for Infectious Disease Research in Zambia (CIDRZ)Academic/Hospital4322018
Christian Medical College, Vellore, IndiaAcademic/Hospital4032011
Government of IndiaGovernment4042005
International Center for Diarrheal Disease ResearchAcademic/Hospital4222008
University of CincinnatiAcademic/Hospital4142005
MerckFor profit3212009
National Institutes of Health (NIH)Government3032005
SanofiFor profit3312013
Bill and Melinda Gates FoundationAcademic/Hospital2022019
China National Pharmaceutical GroupFor profit2222024
SK Bioscience Co., Ltd.For profit2022019
Society for Applied Studies, New DelhiAcademic/Hospital2122005
Stanford UniversityAcademic/Hospital2022005
Thrasher Research FundAcademic/Hospital2012009
University of OxfordAcademic/Hospital2212014
62 organizations
Page 1 / 4

Marketing (1)

OrganizationOrg typeRelationshipDate
GlaxoSmithKlineFor profitNDAApr 4, 2018