Drugs / Rotarix
Rotarix
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Rotarix | — | 2006-02-21 | europa.eu ↗ |
Trials 34
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 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 27 trials · 1 met primary | ||||||
| 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 | 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 | Met primary |
| Phase 2 | NCT00429481 | Jan 2001 → Apr 2003 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00425737 | Aug 2000 → Jul 2001 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 314 trials · 2 met primary | ||||||
| Phase 3 | NCT06025695 | Sep 2023 → May 2024 | gastroenteritis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT04031846 | Sep 2019 → Aug 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT03207750 | Sep 2017 → Oct 2018 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01375647 | May 2011 → Oct 2014 | Rotavirus infection, tropical sprue | University of Vermont | Completed | Mixed |
| Phase 3 | NCT01825109 | Jul 2010 → Apr 2011 | — | International Centre for Diarrhoeal Disease Research, Bangladesh | Completed | No outcome recorded |
| Phase 3 | NCT00533507 | Sep 2007 → Jun 2008 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00480324 | Jun 2007 → Mar 2009 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00420745 | Jan 2007 → Mar 2008 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00396630 | Jan 2007 → Jan 2008 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00329745 | Jan 2007 → Jul 2008 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00363545 | Sep 2006 → Apr 2007 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00241644 | Oct 2005 → Jun 2008 | Rotavirus infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00158756 | Sep 2005 → Nov 2006 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00757770 | Aug 2003 → Jan 2004 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 410 trials · 2 met primary · 1 missed | ||||||
| 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 | Missed primary |
| Phase 4 | NCT02907216 | Sep 2016 → May 2017 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01841671 | Apr 2013 → May 2014 | poliomyelitis | University of Chile | Unknown | No outcome recorded |
| Phase 4 | NCT01266850 | Mar 2011 → Oct 2013 | Rotavirus infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 4 | NCT01198769 | Nov 2010 → Apr 2011 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00995813 | Dec 2009 → May 2012 | Rotavirus infection, chronic intestinal failure | Seattle Children's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00969228 | Aug 2009 → Jul 2010 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00737503 | Sep 2008 → Mar 2011 | Rotavirus infection | International Centre for Diarrhoeal Disease Research, Bangladesh | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT04123119 | Jan → May 2019 | diarrheal disease | Centre for Infectious Disease Research in Zambia | Completed | No outcome recorded |
| Comparator or background therapy28 trials | ||||||
| Phase 1 | NCT03507738 Comparator | Jul 2018 → Jun 2019 | — | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT06647407 Background | Nov 2024 → May 2027 expected | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Active not recruiting | No outcome recorded |
| 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 2/3 | NCT03602053 Comparator | Jan → Oct 2019 | Rotavirus infection, diarrheal disease | Centre for Infectious Disease Research in Zambia | Completed | No outcome recorded |
| 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 | NCT04010448 Comparator | Oct 2019 → Dec 2025 | Rotavirus infection | PATH | Unknown | Missed primary |
| Phase 3 | NCT03621670 Background | Jul 2018 → Dec 2024 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02914184 Comparator | Oct 2016 → Jun 2018 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02584816 Comparator | Nov 2015 → Apr 2017 | Rotavirus infection | Serum Institute of India Pvt. Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02096263 Background | Apr 2014 → Feb 2015 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01978093 Background | Feb 2014 → Mar 2016 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02193061 Comparator | Nov 2013 → Jun 2017 | Rotavirus infection | National Institute of Pediatrics, Mexico | Completed | No outcome recorded |
| Phase 3 | NCT01983540 Background | Oct 2013 → Jun 2015 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, pertussis +2 | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT01480258 Background | Nov 2011 → Oct 2013 | bacterial infectious disease, viral infectious disease | MCM Vaccines B.V. | Completed | Met primary |
| Phase 3 | NCT01345240 Background | Nov 2011 → Jan 2013 | malaria | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01309646 Background | Mar 2011 → Feb 2012 | diphtheria, haemophilus infectious disease, poliomyelitis, tetanus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01000974 Background | Jun 2010 → Nov 2011 | haemophilus infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01003431 Comparator | Dec 2009 → Aug 2010 | Rotavirus infection, diphtheria, pertussis, tetanus | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 3 | NCT00829010 Background | Feb 2009 → Jun 2011 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00808444 Background | Jan → Nov 2009 | streptococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00489554 Background | Jul 2007 → Mar 2008 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00420316 Background | Feb → Aug 2007 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00370318 Background | Sep 2006 → Apr 2007 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| 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 |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2014-07-04 | Institute of Vaccines and Medical Biologicals, Vietnam | Results Nghiên cứu của Mỹ thừa nhận các tác dụng phụ của vắc xin com.vn ↗
Các vắc xin rotavirus - RotaTeq và Rotarix - có liên quan với nguy cơ lồng ruột, là tình trạng một đoạn ruột này chui vào đoạn ruột khác. |
| 2011-07-01 | GlaxoSmithKline | Regulatory GlaxoSmithKline receives new approval for Rotarix and significant new indication for Lamictal® (lamotrigine) in Japan gsk.com ↗ |
| 2010-05-20 | GlaxoSmithKline | Regulatory European Medicines Agency maintains position on the continued use of Rotarix™ (rotavirus vaccine) gsk.com ↗
The announcement today by the EMA is further confirmation that the benefit/risk profile of Rotarix remains positive and unchanged. |
| 2010-05-13 | GlaxoSmithKline | Regulatory FDA says Healthcare Providers can resume use of Rotarix (Rotavirus Vaccine, Live, Oral) gsk.com ↗
GlaxoSmithKline (NYSE: GSK) announced that the Food and Drug Administration (FDA) has determined that U.S. healthcare practitioners can resume the use of Rotarix® (Rotavirus Vaccine, Live, Oral), effective immediately. |
| 2010-05-07 | GlaxoSmithKline | Results GSK Statement on FDA Advisory Committee meeting on Rotavirus vaccines gsk.com ↗
Testing of clinical samples conducted by GSK has not shown any indication of PCV-1 infection in infants who received Rotarix. |
| 2010-03-25 | GlaxoSmithKline | Regulatory Updated GlaxoSmithKline statement on European regulatory guidance relating to manufacture of Rotarix (rotavirus vaccine) gsk.com ↗
GlaxoSmithKline (GSK) today confirmed that the European Medicines Agency (EMA) has maintained its position that it “sees no safety concerns with the Rotarix oral vaccine” and healthcare practitioners in the European Union should continue to use Rotarix™ as indicated. |
| 2010-03-21 | GlaxoSmithKline | Regulatory GlaxoSmithKline statement on new information relating to manufacture of Rotarix (rotavirus vaccine) gsk.com ↗
This notwithstanding, the FDA is recommending that US clinicians and public health professionals temporarily suspend the use of Rotarix as a precautionary measure. |
| 2010-01-26 | GlaxoSmithKline | Results Rotarix™ significantly reduced severe rotavirus gastroenteritis in African babies during their first year of life gsk.com ↗
The New England Journal of Medicine (NEJM) today published the first study demonstrating that Rotarix™, GlaxoSmithKline’s rotavirus vaccine, significantly prevented severe rotavirus gastroenteritis during the first year of life in African babies. |
| 2009-11-29 | GlaxoSmithKline | Regulatory Regulatory Update: GSK files Rotarix for prevention of rotavirus in Japan gsk.com ↗
GlaxoSmithKline (GSK) announced today that it has filed its vaccine for the prevention of rotavirus gastroenteritis (approved as Rotarix ® in a number of countries outside of Japan). |
| 2009-06-04 | GlaxoSmithKline | Regulatory World Health Organization grants Global Prequalification to GSK’s Rotarix™ vaccine gsk.com ↗
The World Health Organisation (WHO) has awarded global prequalification to GlaxoSmithKline Biologicals’ vaccine against rotavirus, Rotarix™. |
All press releases naming this drug 12 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 68 sources stand behind the page.
| Field | Value | Cited 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 ↗ |
| 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 20171“Rotarix (HRV) was administered intramuscularly on Day 1 and Day 61.” NCT03621670 ↗ |
| 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, 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 | 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 |
| Modality | Vaccine | “GSK Biologicals' live attenuated human rotavirus vaccine” NCT00158756 ↗ |
| Route | Oral | “2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.” NCT00158756 ↗ |