live tetravalent chimeric dengue vaccine
Trade name: DENGVAXIA
Vaccineapproved
Approved
May 1, 2019
Clinical trial activity
20 trials · 9 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
18
Phase 3
5
Phase 4
0
Earliest trial started Aug 1, 2006 (NCT00730288)
Timeline
2000s
- Jan 1, 2006
Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2010
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2016
Earliest Phase 3 Sponsor(trial)
- May 1, 2019
Sanofi-Aventis — Earliest FDA Approval
- May 1, 2019
Sanofi-Aventis — NDA Secondary Org
- May 1, 2019
Sanofi-Aventis — NDA Organization
Indications
Approved for
Mechanism of action
- Dengue virusImmunity, active
Dengue virus immunity, active
Approval history
- approvedMay 1, 2019
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Also known as
- chimeric tetravalent dengue vaccine (serotype 1, 2, 3, 4)
- cyd dengue vaccine
- live tetravalent chimeric dengue vaccine
- tetravalent blending vdv-2/cyd-1,3,4 dengue (vero)
- tetravalent chimeric dengue vaccine
- tetravalent cyd-1,2,3,4 dengue (vero)
- tetravalent dengue vaccine (tvdv) with vaxfectin
- tetravalent dengue vaccine tvdv with vaxfectin
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04313244 | Phase 3 | Aug 16, 2020 | Takeda |
| NCT02741128 | Phase 2 | Mar 20, 2019 | Sanofi, Sanofi-Aventis |
| NCT03525119 | Phase 3 | May 16, 2018 | Takeda |
| NCT02993757 | Phase 3 | Dec 1, 2016 | Sanofi, Sanofi-Aventis |
| NCT02979535 | Phase 3 | Nov 16, 2016 | Sanofi, Sanofi-Aventis |
| NCT02824198 | Phase 2 | Jul 1, 2016 | Sanofi |
| NCT02628444 | Phase 2 | May 2, 2016 | Sanofi |
| NCT02623725 | Phase 2 | Apr 14, 2016 | Sanofi |
| NCT02992418 | Phase 3 | Feb 19, 2016 | Sanofi, Sanofi-Aventis |
| NCT01943825 | Phase 2 | Sep 1, 2013 | Department of Defense, Sanofi, Sanofi-Aventis |
| NCT01502358 | Phase 1 | Dec 1, 2011 | United States Army, United States Navy, Vical |
| NCT01511250 | Phase 2 | Nov 16, 2011 | Inviragen, Takeda |
| NCT01110551 | Phase 1 | May 1, 2010 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT00993447 | Phase 2 | Oct 1, 2009 | Sanofi |
| NCT00880893 | Phase 2 | Apr 1, 2009 | Sanofi |
| NCT00875524 | Phase 2 | Mar 1, 2009 | Sanofi |
| NCT00842530 | Phase 2 | Feb 1, 2009 | Sanofi |
| NCT00788151 | Phase 2 | Oct 1, 2008 | Sanofi |
| NCT00740155 | Phase 2 | Aug 1, 2008 | Sanofi |
| NCT00730288 | Phase 2 | Aug 1, 2006 | Sanofi |
Showing 20 of 20 trials
Page 1 / 1
Organizations
Research & Development (9)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sanofi | For profit | 15 | 15 | 2 | 2006 |
| Sanofi-Aventis | For profit | 5 | 0 | 2 | 2013 |
| Takeda | For profit | 3 | 3 | 2 | 2011 |
| Department of Defense | Government | 1 | 0 | 1 | 2013 |
| Inviragen | For profit | 1 | 0 | 1 | 2011 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 1 | 1 | 1 | 2010 |
| United States Army | Government | 1 | 1 | 1 | 2011 |
| United States Navy | Government | 1 | 0 | 1 | 2011 |
| Vical | For profit | 1 | 0 | 1 | 2011 |
9 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Sanofi-Aventis | For profit | NDA2 | May 1, 2019 |
| Sanofi-Aventis | For profit | NDA | May 1, 2019 |