rotavirus vaccine, live, oral, tetravalent
Trade name: RotaShield
Vaccinewithdrawn
Approved
Aug 31, 1998
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
3 trials · 2 clinical orgs · 0 marketing orgs
Phase 1
3
Phase 2
2
Phase 3
0
Phase 4
0
Earliest trial started Sep 1, 2009 (NCT00757926)
Timeline
1990s
- Aug 31, 1998
Earliest FDA Approval
2000s
- Jan 1, 2009
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Studied for
Mechanism of action
- RotavirusImmunity, active
Rotavirus immunity, active
Approval history
- withdrawnAug 31, 1998
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaRotavirus vaccine ↗
Also known as
- live attenuated tetravalent (g1-g4) bovine-human reassortant rotavirus vaccine
- rotashield
- rotavirus serotype 1 reassortant, rotavirus serotype 2 reassortant, rotavirus serotype 3 rhesus, rotavirus serotype 4 reassortant
- rotavirus serotype g1, serotype g2, serotype g3, serotype g4, serotype p1
- rotavirus vaccine, live, oral, tetravalent
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01061658 | Phase 1/Phase 2 (Phase 2) | Jul 1, 2010 | Shantha Biotechnics Limited |
| NCT01091298 | Phase 1 | Apr 1, 2010 | Shantha Biotechnics Limited |
| NCT00757926 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2009 | PATH, Shantha Biotechnics Limited |
Showing 3 of 3 trials
Page 1 / 1
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Shantha Biotechnics Limited | For profit | 3 | 3 | 2 | 2009 |
| PATH | Academic/Hospital | 1 | 0 | 1 | 2009 |
2 organizations
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