Drugs / RotaTeq
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | RotaTeq | — | 2006-06-26 | europa.eu ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00953056 | Sep 2009 → Mar 2010 | Rotavirus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00836498 | Jan 2009 → Jan 2010 | Rotavirus infection | Merck Sharp & Dohme LLC | Terminated | No outcome recorded Stop: Business |
| Phase 21 trial | ||||||
| Phase 2 | NCT00880698 | Dec 2009 → Jan 2014 | HIV infectious disease, Rotavirus infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Mixed |
| Phase 310 trials · 7 met primary | ||||||
| Phase 3 | NCT04481191 | Aug 2020 → May 2021 | Rotavirus infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT03893448 | Jun 2019 → May 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 3 | NCT01003431 | Dec 2009 → Aug 2010 | Rotavirus infection, diphtheria, pertussis, tetanus | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 3 | NCT00718237 | Aug 2008 → Aug 2009 | Rotavirus infection, gastroenteritis | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00362648 | Mar 2007 → Mar 2009 | diarrheal disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00443846 | Feb → Sep 2007 | Rotavirus infection, meningococcal meningitis | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00258154 | Feb → Nov 2006 | Rotavirus infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00092456 | May 2003 → Aug 2004 | Rotavirus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00092443 | Sep 2002 → Jun 2004 | Rotavirus infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00090233 | Jan 2001 → Oct 2004 | Rotavirus infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 43 trials · 1 met primary | ||||||
| Phase 4 | NCT01926015 | Sep 2013 → Jun 2014 | Rotavirus infection | Merck Sharp & Dohme LLC | Completed | 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 | NCT00740935 | May 2007 → Dec 2010 | Rotavirus infection | University Hospital, Brest | Completed | No outcome recorded |
| Comparator or background therapy16 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 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 | NCT03620162 Background | Oct 2018 → Dec 2020 | pneumococcal infection | Merck Sharp & Dohme LLC | 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 | NCT01839188 Background | May 2013 → Mar 2014 | meningococcal infection, viral infectious disease | MCM Vaccines B.V. | Completed | Met primary |
| Phase 3 | NCT01600092 Comparator | Apr 2013 → Mar 2014 | Rotavirus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01839175 Background | Apr 2013 → Jul 2014 | meningococcal infection, viral infectious disease | Sanofi Pasteur, a Sanofi Company | Completed | Met primary |
| Phase 3 | NCT01480258 Background | Nov 2011 → Oct 2013 | bacterial infectious disease, viral infectious disease | MCM Vaccines B.V. | Completed | Met primary |
| Phase 3 | NCT01341639 Background | May 2011 → Mar 2013 | bacterial infectious disease, viral infectious disease | MCM Vaccines B.V. | Completed | Met primary |
| Phase 3 | NCT01340937 Background | May 2011 → Dec 2012 | bacterial infectious disease, viral infectious disease | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 3 | NCT01337167 Background | Apr 2011 → May 2013 | bacterial infectious disease, viral infectious disease | Merck Sharp & Dohme LLC | Completed | Mixed |
| 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 |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2012-05-25 | Merck Sharp & Dohme LLC | Government of Rwanda Introduces Merck’s ROTATEQ® (Rotavirus Vaccine, Live, Oral, Pentavalent) to Help Protect Children Against Rotavirus merck.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| 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 ↗33“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 ↗ “Biological: Rotateq™” NCT00090233 ↗ “RotaTeq® Rotarix®” NCT06647407 ↗ |
| Known as | PRV | “BACKGROUND: The pentavalent rotavirus vaccine (PRV), RotaTeq, can be concomitantly administered with most routine childhood vaccines.” PMID 19209092 ↗ Mar 2009 |
| 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 20136“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 ↗ |
| Modality | Vaccine | “live pentavalent human-bovine (WC3 strain) reassortant rotavirus vaccine” PMID 16394299 ↗ Jan 2006 |
| Route | Oral | “administered orally” NCT00090233 ↗ |