typhoid vaccine, live oral
Trade name: Vivotif
Approved
Dec 15, 1989
Ty21a is a live attenuated bacterial vaccine that protects against typhoid. First licensed in Europe in 1983 and in the United States in 1989, it is an orally administered, live-attenuated Ty2 strain of S. Typhi in which multiple genes, including the genes responsible for the production of Vi, have been deleted so as to render it harmless but nevertheless immunogenic. It is one of the three typhoid vaccines currently recommended by the World Health Organization. — Wikipedia
Clinical trial activity
8 trials · 7 clinical orgs · 2 marketing orgs
Earliest trial started Jan 16, 2004 (NCT03971669)
Timeline
1980s
- Jun 1, 1989
Swiss Serum Institute — First NDA Organization
- Jun 1, 1989
Swiss Serum Institute — NDA Organization
- Dec 15, 1989
Earliest FDA Approval
- Dec 15, 1989
Emergent BioSolutions — NDA Secondary Org
2000s
- Jan 1, 2008
Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2019
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Studied for
- Cholera · Phase 4
- Cholera Vaccines · Phase 4
- Colitis, Ulcerative · Phase 2
- Healthy Volunteers · Phase 4
- Hepatitis A · Phase 4
- Inflammation · Early Phase 1
- Influenza, Human · Phase 4
- Intestinal Neoplasms · Early Phase 1
- Risk Reduction Behavior · Phase 4
- Typhoid Fever · Phase 4
- Typhoid-Paratyphoid Vaccines · Phase 4
- Vaccine-Preventable Diseases · Phase 4
- Vaccines · Early Phase 1
Mechanism of action
- Salmonella typhiImmunity, active
Salmonella typhi immunity, active
Approval history
- approvedDec 15, 1989
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaTy21a ↗
Also known as
- ty21a, vivotif berna
- typhoid vaccine, live oral
- vivotif
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06104345 | Phase 4 | Oct 31, 2023 | University of Helsinki |
| NCT04083950 | Early Phase 1 (Phase 1) | Oct 1, 2019 | United States Department of Agriculture |
| NCT03705585 | Phase 4 | Nov 5, 2018 | University of Maryland |
| NCT03312699 | Phase 4 | Sep 19, 2017 | National Institute of Allergy and Infectious Diseases (NIAID), Stanford University |
| NCT03970304 | Phase 4 | Oct 24, 2013 | University of Maryland |
| NCT02121145 | Phase 4 | Oct 1, 2013 | University of Helsinki |
| NCT00751933 | Phase 2 | Oct 1, 2008 | University of Bergen, Western Norway Regional Health Authority |
| NCT03971669 | Phase 4 | Jan 16, 2004 | University of Maryland |
Organizations
Research & Development (7)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| University of Maryland | Academic/Hospital | 3 | 3 | 1 | 2004 |
| University of Helsinki | Academic/Hospital | 2 | 2 | 1 | 2013 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 1 | 0 | 1 | 2017 |
| Stanford University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| United States Department of Agriculture | Government | 1 | 1 | 1 | 2019 |
| University of Bergen | Academic/Hospital | 1 | 1 | 1 | 2008 |
| Western Norway Regional Health Authority | Government | 1 | 0 | 1 | 2008 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Emergent BioSolutions | For profit | NDA2 | Dec 15, 1989 |
| Swiss Serum Institute | For profit | NDA | Jun 1, 1989 |