rotavirus vaccine, live, oral, pentavalent
Trade name: Rotateq
Vaccineapproved
Approved
Feb 3, 2006
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
44 trials · 22 clinical orgs · 1 marketing orgs
Phase 1
3
Phase 2
34
Phase 3
31
Phase 4
6
Earliest trial started Jan 1, 2001 (NCT00090233)
Timeline
Indications
Approved for
Studied for
- Bacterial Infections · Phase 3
- Diarrhea · Phase 4
- Diphtheria · Phase 3
- Diphtheria Toxoid · Phase 2
- Esophageal and Gastric Varices · Phase 2
- Fever · Phase 3
- Gastroenteritis · Phase 4
- Haemophilus influenzae · Phase 2
- Healthy Volunteers · Phase 3
- Hepatitis B · Phase 2
- HIV Infections · Phase 2
- Intussusception · Phase 4
- Measles · Phase 2
- Meningitis · Phase 2
- Meningococcal Infections · Phase 2
- Mumps Vaccine · Phase 2
- Neisseria meningitidis · Phase 3
- Pertussis Vaccine · Phase 2
- Pneumococcal Infections · Phase 3
- Pneumococcal Vaccines · Phase 3
- Pneumonia · Phase 3
- Poliovirus Vaccines · Phase 2
- Rotavirus · Phase 3
- Rotavirus Infections · Phase 4
- Rotavirus Vaccines · Phase 3
- Rubella Vaccine · Phase 2
- Short Bowel Syndrome · Phase 1
- Tetanus · Phase 3
- Virus Diseases · Phase 3
- Vomiting · Phase 3
- Whooping Cough · Phase 3
Mechanism of action
- RotavirusImmunity, active
Rotavirus immunity, active
Approval history
- approvedFeb 3, 2006
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaRotavirus vaccine ↗
Also known as
- live attenuated pentavalent (g1-g2-g3-g4-g9) human x bovine reassortant rotavirus vaccine
- pentavalent rotavirus vaccine
- rotateq
- rotateq
- rotavirus vaccine, live, oral, pentavalent
- rotavirus vaccine, live, oral, pentavalent
- rv5
- v260
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06824181 | Phase 3 | Feb 27, 2025 | Sanofi |
| NCT06824194 | Phase 3 | Feb 18, 2025 | Sanofi |
| NCT06967272 | Phase 2 | Jan 20, 2025 | China National Pharmaceutical Group |
| NCT06736041 | Phase 3 | Dec 16, 2024 | Sanofi-Aventis |
| NCT04481191 | Phase 3 | Aug 25, 2020 | Merck |
| NCT04398706 | Phase 2 | May 18, 2020 | Sanofi, Sanofi-Aventis |
| NCT03893448 | Phase 3 | Jun 19, 2019 | Merck |
| NCT05032391 | Phase 3 | Feb 22, 2019 | Limited Liability Company Pharm Aid, Perm State Medical University named after Academician E.A. Wagner, Tyumen State Medical Academy |
| NCT03630705 | Phase 3 | Oct 31, 2018 | Sanofi-Aventis |
| NCT03620162 | Phase 3 | Oct 18, 2018 | Merck |
| NCT03691610 | Phase 3 | Sep 28, 2018 | Sanofi-Aventis |
| NCT05037435 | Phase 3 | Jun 25, 2018 | Limited Liability Company Pharm Aid, Perm State Medical University named after Academician E.A. Wagner |
| NCT03537508 | Phase 3 | Apr 25, 2018 | Sanofi-Aventis |
| NCT03474055 | Phase 2/Phase 3 (Phase 3) | Oct 30, 2017 | Serum Institute of India Pvt. Ltd. |
| NCT02542462 | Phase 4 | Nov 1, 2015 | Centers for Disease Control and Prevention (CDC), University of Cincinnati |
| NCT02286895 | Phase 4 | Oct 1, 2014 | Centre for Vaccine Development, Mali, PATH, University of Maryland |
| NCT02062385 | Phase 3 | May 1, 2014 | Merck |
| NCT02133690 | Phase 3 | May 1, 2014 | PATH, Serum Institute of India Pvt. Ltd. |
| NCT01960725 | Phase 4 | Feb 1, 2014 | Duke University, Merck |
| NCT02193061 | Phase 3 | Nov 1, 2013 | Government of Mexico, Merck |
Showing 20 of 44 trials
Page 1 / 3
Organizations
Research & Development (22)
22 organizations
Page 1 / 2
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Merck | For profit | NDA | Feb 6, 2006 |