Drugs / ROTAVAC®
Trials 4 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03602053 | Jan → Oct 2019 | Rotavirus infection, diarrheal disease | Centre for Infectious Disease Research in Zambia | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT03367559 | Feb 2018 → May 2019 | Rotavirus infection | Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products | Unknown | No outcome recorded |
| Phase 3 | NCT04596696 | Dec 2017 → Dec 2018 | Rotavirus infection | Bharat Biotech International Limited | Completed | No outcome recorded |
| Phase 3 | NCT01305109 | Mar 2011 → Dec 2013 | Rotavirus infection | Bharat Biotech International Limited | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04819412 Comparator | Mar → Oct 2015 | Rotavirus infection | Bharat Biotech International Limited | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Rotavac | “An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series” NCT04596696 ↗5“Rotavac® is in frozen form and is thawed till fully liquid prior to administration.” NCT03367559 ↗ |
| Known as | ORV 116E | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01305109 ↗ |
| Modality | Vaccine | “three doses of oral human-bovine natural reassortant vaccine (116E)” PMID 24629994 ↗ Mar 2014 |
| Route | Oral | “Oral Rotavirus Vaccine 116E (ORV 116E)” NCT01305109 ↗ |