Drugs / Rotarix
last change Jul 2026 re-read 2 minutes ago

Rotarix

Vaccine

Developed for
Rotavirus infection · diarrheal disease · gastroenteritis · HIV infectious disease
Investigated by
GlaxoSmithKline · Merck Sharp & Dohme LLC · PATH · International Centre for Diarrhoeal Disease Research, Bangladesh · Sanofi Pasteur, a Sanofi Company · Bill and Melinda Gates Foundation
+46 more · Centers for Disease Control and Prevention · Centre for Infectious Disease Research in Zambia · Christian Medical College, Vellore, India · Imperial College London · National Institute of Allergy and Infectious Diseases (NIAID) · Thrasher Research Fund · University of Vermont · Butantan Institute · Center for Research and Production of Vaccines and Biologicals, Vietnam · Center for Vaccine Development - Mali · Charles H. Hood Foundation · Children's Hospital Medical Center, Cincinnati · Children's Hospital Number 1, Ho Chi Minh City, Vietnam · China National Biotec Group Company Limited · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · European Centre for Disease Prevention and Control, SE-171, Stockholm · French National Institute of Health and Medical Research · Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam · Hung Vuong Hospital · MCM Vaccines B.V. · Medical Research Council · Menzies School of Health Research · Ministry of Science and Technology, India · Murdoch Childrens Research Institute · National Center for Research Resources (NCRR) · National Institute of Hygiene and Epidemiology, Vietnam · National Institutes of Health (NIH) · Navrongo Health Research Centre, Ghana · Noguchi Memorial Institute for Medical Research · Oxford University Clinical Research Unit, Vietnam · Public Health England · SK Bioscience Co., Ltd. · Seattle Children's Hospital · Sichuan Center for Disease Control and Prevention · Stanford University · Telethon Kids Institute · The Swedish Institute for Infectious Disease Control, SE-171 82 SOLNA · University College, London · University Hospital, Brest · University of Chile · University of Liverpool · University of Maryland · University of Oxford · University of Virginia · Washington University School of Medicine · Wellcome Sanger Institute

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Rotashield 1999-05-07 europa.eu

Trials 68 · started per year

today
EU approved 1999
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19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT01086436 Mar → Apr 2010 Rotavirus infection GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT01162590 Mar 2010 Rotavirus infection GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT00953056 Sep 2009 → Mar 2010 Rotavirus infection Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT00981669 Mar 2009 → Mar 2010 Rotavirus infection Butantan Institute Completed No outcome recorded
Phase 1 NCT00836498 Jan 2009 → Jan 2010 Rotavirus infection Merck Sharp & Dohme LLC Terminated No outcome recorded
Phase 215 trials
Phase 2 NCT04658914 Apr 2021 → Aug 2022 Rotavirus infection, diarrheal disease Centre for Infectious Disease Research in Zambia Completed No outcome recorded
Phase 2 NCT04344054 Feb 2021 → Sep 2022 Rotavirus infection PATH Completed No outcome recorded
Phase 2 NCT04398706 May 2020 → Aug 2023 chickenpox, diphtheria, haemophilus meningitis, hepatitis B virus infection +6 Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 2 NCT02482636 Aug 2015 → Nov 2017 infectious disease University of Oxford Completed No outcome recorded
Phase 2 NCT01049035 Dec 2009 → Feb 2012 meningitis, meningococcal infection Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 2 NCT00880698 Dec 2009 → Jan 2014 HIV infectious disease, Rotavirus infection National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT01377571 Oct 2009 → Mar 2010 diarrheal disease National Institute of Hygiene and Epidemiology, Vietnam Completed No outcome recorded
Phase 2 NCT00432380 Mar → Sep 2007 Rotavirus infection GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT00263666 Mar 2005 → Feb 2008 Rotavirus infection GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT00383903 Sep 2003 → Sep 2004 Rotavirus infection GlaxoSmithKline Completed No outcome recorded
Phase 329 trials
Phase 3 NCT06025695 Sep 2023 → May 2024 gastroenteritis GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT04481191 Aug 2020 → May 2021 Rotavirus infection Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT04031846 Sep 2019 → Aug 2021 pneumococcal infection Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT03893448 Jun 2019 → May 2021 pneumococcal infection Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT03630705 Oct 2018 → Feb 2022 Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 3 NCT03537508 Apr 2018 → Sep 2023 Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 3 NCT03207750 Sep 2017 → Oct 2018 Rotavirus infection GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT02062385 May 2014 → Jun 2015 Rotavirus infection Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT01375647 May 2011 → Oct 2014 Rotavirus infection, tropical sprue University of Vermont Completed No outcome recorded
Phase 3 NCT01825109 Jul 2010 → Apr 2011 International Centre for Diarrhoeal Disease Research, Bangladesh Completed No outcome recorded
Phase 418 trials
Phase 4 NCT03587389 Mar 2019 → Jun 2022 Rotavirus infection, diarrheal disease Oxford University Clinical Research Unit, Vietnam Completed No outcome recorded
Phase 4 NCT02941107 Mar 2018 → Jul 2026 overdue Rotavirus infection Telethon Kids Institute Active not recruiting No outcome recorded
Phase 4 NCT02992197 Jun 2017 → Jun 2018 Rotavirus infection University of Vermont Completed No outcome recorded
Phase 4 NCT02907216 Sep 2016 → May 2017 Rotavirus infection GlaxoSmithKline Completed No outcome recorded
Phase 4 NCT02286895 Oct 2014 → Mar 2015 Rotavirus infection PATH Completed No outcome recorded
Phase 4 NCT02153866 Dec 2013 → May 2014 Rotavirus infection Sichuan Center for Disease Control and Prevention Unknown No outcome recorded
Phase 4 NCT01926015 Sep 2013 → Jun 2014 Rotavirus infection Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 4 NCT01841671 Apr 2013 → May 2014 poliomyelitis University of Chile Unknown No outcome recorded
Phase 4 NCT01700621 Jan → Sep 2013 Rotavirus infection PATH Completed No outcome recorded
Phase 4 NCT01575197 Sep 2012 → Feb 2013 Rotavirus infection PATH Completed No outcome recorded
Phase not applicable1 trial
NCT04123119 Jan → May 2019 diarrheal disease Centre for Infectious Disease Research in Zambia Completed No outcome recorded
Also used as a comparator or background therapy in 42 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT03507738 Comparator Jul 2018 → Jun 2019 Tanabe Pharma Corporation Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT06647407 Background Nov 2024 → May 2027 expected meningococcal infection Sanofi Pasteur, a Sanofi Company Active not recruiting No outcome recorded
Phase 1/2 NCT02728869 Comparator Jun 2016 → Mar 2017 Rotavirus infection MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd. Completed No outcome recorded
Phase 22 trials
Phase 2 NCT01090453 Background May 2010 → Oct 2011 diphtheria, haemophilus infectious disease, hepatitis B virus infection, meningococcal infection +2 GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT01110044 Background Apr 2010 → Aug 2012 Rotavirus infection GlaxoSmithKline Withdrawn No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03602053 Comparator Jan → Oct 2019 Rotavirus infection, diarrheal disease Centre for Infectious Disease Research in Zambia Completed No outcome recorded
Phase 333 trials
Phase 3 NCT06824181 Background Feb 2025 → Sep 2027 expected Sanofi Active not recruiting No outcome recorded
Phase 3 NCT06824194 Background Feb 2025 → Oct 2027 expected Sanofi Active not recruiting No outcome recorded
Phase 3 NCT06736041 Background Dec 2024 → May 2027 expected Sanofi Pasteur, a Sanofi Company Active not recruiting No outcome recorded
Phase 3 NCT06397768 Background May 2024 → Sep 2025 respiratory syncytial virus infectious disease Sanofi Pasteur, a Sanofi Company Terminated No outcome recorded
Phase 3 NCT05794230 Background Mar 2023 → Nov 2025 meningococcal infection Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 43 trials
Phase 4 NCT02847026 Comparator Sep 2016 → May 2017 poliomyelitis Centers for Disease Control and Prevention Completed No outcome recorded
Phase 4 NCT02542462 Comparator Nov 2015 → May 2017 Rotavirus infection, intussusception Children's Hospital Medical Center, Cincinnati Completed No outcome recorded
Phase 4 NCT02002156 Background Jun 2014 → Aug 2016 tuberculosis University of Oxford Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2011-11-21 Daiichi Sankyo Launch of Rotarix(R) oral liquid formulation First vaccine to prevent rotavirus gastroenteritis in Japan daiichisankyo.com

Evidence & citations 22 cited values

Every value below carries the sentence it was read from. 121 sources stand behind the page.

FieldValueCited text
Known as ROTARIX “Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in...” NCT06025695
64

“Participating infants were randomized at 6-8 weeks of age to receive either three doses of TV P2-VP8 intramuscularly (IM) plus oral placebo or two doses of ROTARIX® (oral) plus...” PMID 41319434 Nov 2025

“Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2...” NCT00363545

“three doses of BRV-PV or two doses of Rotarix® and one dose of placebo were given to healthy infants at 6, 10, and 14 weeks of age.” PMID 30104114 Aug 2018

“Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine” NCT01825109

Rotarix™ 1.5 mL oral dose at 2 and 4 months of age (subset 1, Italy and Sweden)” NCT01480258

Rotarix™ is in routine use in Zambia administered at 6 and 10 weeks infant age” NCT04123119

“RotaTeq® Rotarix®” NCT06647407

ROTARIX™” NCT02941107

NCT01377571

NCT01003431

NCT04658914

NCT01000974

NCT00808444

NCT00829010

NCT03587389

NCT03507738

NCT01345240

NCT00420745

NCT04031846

NCT00420316

NCT00329745

NCT00995813

NCT01090453

NCT01309646

NCT00969228

NCT00396630

NCT02002156

NCT02193061

NCT00757770

NCT02992197

NCT01983540

NCT04344054

NCT03207750

NCT03621670

NCT00425737

NCT03602053

NCT06824194

NCT00158756

NCT01162590

NCT02542462

NCT00533507

NCT00489554

NCT02914184

NCT00737503

NCT02847026

NCT00263666

NCT01110044

NCT01086436

NCT01978093

NCT02096263

NCT00432380

NCT02941107

NCT01375647

NCT01198769

NCT01841671

NCT00241644

NCT02584816

NCT00370318

NCT06824181

NCT00480324

NCT02907216

NCT04010448

NCT01266850

NCT00429481

Known as GSK444563 “Rotarix (GSK444563)” NCT02907216
Known as HRV “the human rotavirus vaccine (HRV; Rotarix) given early at 6 and 10 wk of age” PMID 28419095 Apr 2017
1

“Rotarix (HRV) was administered intramuscularly on Day 1 and Day 61.” NCT03621670

Known as HRV vaccine ClinicalTrials.gov intervention name — accepted as the source's own label NCT00385320
1

NCT00383903

Known as Human rotavirus RIX4414 strain vaccine ClinicalTrials.gov intervention name — accepted as the source's own label NCT03632720
Known as Human Rotavirus Vaccine ClinicalTrials.gov intervention name — accepted as the source's own label NCT01575197
1

NCT00729001

Known as Pentavalent rotavirus vaccine ClinicalTrials.gov intervention name — accepted as the source's own label NCT03537508
1

NCT02286895

Known as PRV “Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV).” NCT02286895
2

“BACKGROUND: The pentavalent rotavirus vaccine (PRV), RotaTeq, can be concomitantly administered with most routine childhood vaccines.” PMID 19209092 Mar 2009

“The live oral pentavalent rotavirus vaccine (PRV) is well tolerated and highly efficacious against rotavirus gastroenteritis.” PMID 18756184 Oct 2008

Known as RIX4414 “This Phase-IV study evaluated the human rotavirus (RV) vaccine Rotarix (RIX4414) to provide additional local clinical data to the Taiwan Food and Drug Association (NCT01198769).” PMID 24079716 Jan 2013
Known as Rotarix vaccine ClinicalTrials.gov intervention name — accepted as the source's own label NCT01700621
Known as Rotarix, GlaxoSmithKline UK “Rotarix®, GlaxoSmithKline UK” NCT02002156
Known as RotarixTM “a 2-dose (RotarixTM) oral rotavirus vaccine will be offered during the study” NCT01841671
Known as Rotateq “Three oral doses (\~8.81 X 10\^7 IU/Dose for Lot 1; \~8.01 X 10\^7 IU/Dose for Lot 2; and \~6.91 X 10\^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral,...” NCT00092456
35

“BACKGROUND: The pentavalent rotavirus vaccine (PRV), RotaTeq, can be concomitantly administered with most routine childhood vaccines.” PMID 19209092 Mar 2009

“[Intervention name: RotaTeq™ administered concomitantly with Tritanrix™ HepB (DTwP)] Three 2.0 mL oral doses of RotaTeq™” NCT01003431

“Both groups received concomitantly Prevnar 13 (PCV13) and Rotateq (RV5) at 2, 3 and 4 months of age” PMID 27846055 Feb 2017

RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age (subset 2, Finland)” NCT01480258

“Single 2.0 mL dose V260 (RotaTeq™) administered orally at enrollment.” NCT00953056

“V260 (RotaTeq™; live, oral, pentavalent rotavirus vaccine)” NCT02062385

RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age” NCT03673462

“Biological: Rotateq™” NCT00090233

RotaTeq® Rotarix®” NCT06647407

NCT02542462

NCT00740935

NCT00092443

NCT00090233

NCT01340937

NCT00718237

NCT03893448

NCT00443846

NCT01839175

NCT04481191

NCT06736041

NCT00362648

NCT06824194

NCT01600092

NCT06824181

NCT00880698

NCT03620162

NCT02193061

NCT02728869

NCT01266850

NCT01926015

NCT01337167

NCT02847026

NCT01839188

NCT01341639

NCT00836498

Known as RotaTeq Vaccine “RotaTeq™ Vaccine” NCT00496054
Known as Rotavirus vaccine ClinicalTrials.gov intervention name — accepted as the source's own label NCT05794230
9

NCT01049035

NCT00981669

NCT02153866

NCT01199874

NCT00346892

NCT02482636

NCT01616693

NCT03673462

NCT06397768

Known as Rotavirus Vaccine, Live, Oral, Pentavalent ClinicalTrials.gov intervention name — accepted as the source's own label NCT03691610
3

NCT04398706

NCT00130832

NCT00166517

Known as Rotavirus Vaccine, Live, Pentavalent ClinicalTrials.gov intervention name — accepted as the source's own label NCT03630705
Known as RV1 “ROTARIX™ (RV1) is a live-attenuated human monovalent oral vaccine containing attenuated G1P\[8\] human rotavirus strain sponsored and distributed in Australia by...” NCT02941107
4

“Both groups received concomitantly Prevnar 13 (PCV13) and Rotateq (RV5) or Rotarix (RV1) at 2, 4months of age and PCV13 at 11-12months.” PMID 27288217 Jun 2016

“the pentavalent RotaTeq (RV5) and monovalent Rotarix (RV1)” NCT02847026

“monovalent rotavirus vaccine (Rotarix®, RV1) alone” NCT02542462

“Rotarix™ (RV1)” PMID 38463163 Feb 2024

Known as RV5 “Since being introduced in routine infant immunization schedules in the United States in 2006, the oral live pentavalent rotavirus vaccine RV5 (RotaTeq™) has contributed to...” PMID 23732903 May 2013
6

“Both groups received concomitantly Prevnar 13 (PCV13) and Rotateq (RV5) or Rotarix (RV1) at 2, 4months of age and PCV13 at 11-12months.” PMID 27288217 Jun 2016

“Both groups received concomitantly Prevnar 13 (PCV13) and Rotateq (RV5) at 2, 3 and 4 months of age” PMID 27846055 Feb 2017

“the pentavalent RotaTeq (RV5) and monovalent Rotarix (RV1)” NCT02847026

“pentavalent rotavirus vaccine (RotaTeq®, RV5)” NCT02542462

“the live pentavalent rotavirus vaccine (RV5)” PMID 25424929 2014

“RotaTeq™ (RV5)” PMID 38463163 Feb 2024

Known as V260 “RotaTeq™ (V260)” NCT01926015
1

NCT02062385

Modality Vaccine “live pentavalent human-bovine (WC3 strain) reassortant rotavirus vaccinePMID 16394299 Jan 2006
Route Oral “administered orally” NCT00090233