hepatitis-a virus (inactivated) / hepatitis-b surface antigen
Trade name: twinrix
Vaccineapproved
Approved
May 11, 2001
Combined hepatitis A and B vaccine, is used to provide protection against hepatitis A and hepatitis B. It is given by injection into muscle. — Wikipedia
Clinical trial activity
8 trials · 12 clinical orgs · 2 marketing orgs
Phase 1
0
Phase 2
4
Phase 3
2
Phase 4
1
Earliest trial started Sep 1, 2003 (NCT00197171)
Timeline
2000s
- May 11, 2001
SmithKline Beecham — Earliest FDA Approval
- May 11, 2001
SmithKline Beecham — NDA Organization
- May 11, 2001
GlaxoSmithKline — NDA Secondary Org
- Jan 1, 2003
GlaxoSmithKline — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2006
Earliest Phase 2 Sponsor(trial)
Indications
Studied for
- Bipolar Disorder · Phase 2
- Depression · Phase 2
- Hepatitis A · Phase 4
- Hepatitis B · Phase 4
- HIV Infections · Phase 2
- Liver Cirrhosis · Phase 2
- Meningitis, Meningococcal · Phase 3
- Meningococcal Infections · Phase 3
- Psychotic Disorders · Phase 2
- Schizophrenia · Phase 2
- Substance-Related Disorders · Phase 2
- Vaccination · Phase 2
- Vaccines · Phase 2
Mechanism of action
- Hepatitis A virusImmunity, active
Hepatitis A virus immunity, active
- Hepatitis B virusImmunity, active
Hepatitis B virus immunity, active
Approval history
- approvedMay 11, 2001
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaHepatitis A and B vaccine ↗
Also known as
- combined hepatitis a and b vaccine
- hepatitis a and b vaccine
- hepatitis a & b vaccine
- hepatitis-a virus (inactivated) / hepatitis-b surface antigen
- hepatitis-a virus(inactivated) / hepatitis-b surface antigen
- hepatitisa virus (inactivated) / hepatitis b surface antigen
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05028322 | Phase 2 | Nov 1, 2021 | University of Lorraine |
| NCT04503993 | N/A | Feb 25, 2020 | University of California, Davis |
| NCT02605538 | N/A | Oct 1, 2015 | Karolinska Institute |
| NCT02445703 | Phase 4 | May 1, 2014 | Government of China, Sinovac Biotech Co., Ltd |
| NCT01453348 | Phase 3 | Oct 1, 2011 | GlaxoSmithKline, Novartis |
| NCT00316303 | Phase 2 | Feb 28, 2006 | Dartmouth University, National Institute of Mental Health (NIMH), University of Maryland |
| NCT00244374 | N/A | Aug 1, 2004 | National Institute on Drug Abuse (NIDA), University of California, San Francisco |
| NCT00197171 | Phase 3 | Sep 1, 2003 | GlaxoSmithKline |
Showing 8 of 8 trials
Page 1 / 1
Organizations
Research & Development (12)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 2 | 1 | 1 | 2003 |
| Dartmouth University | Academic/Hospital | 1 | 1 | 1 | 2006 |
| Government of China | Government | 1 | 0 | 1 | 2014 |
| Karolinska Institute | Academic/Hospital | 1 | 1 | 1 | 2015 |
| National Institute of Mental Health (NIMH) | Government | 1 | 0 | 1 | 2006 |
| National Institute on Drug Abuse (NIDA) | Government | 1 | 0 | 1 | 2004 |
| Novartis | For profit | 1 | 1 | 1 | 2011 |
| Sinovac Biotech Co., Ltd | For profit | 1 | 1 | 1 | 2014 |
| University of California, Davis | Academic/Hospital | 1 | 1 | 1 | 2020 |
| University of California, San Francisco | Academic/Hospital | 1 | 1 | 1 | 2004 |
| University of Lorraine | Academic/Hospital | 1 | 1 | 1 | 2021 |
| University of Maryland | Academic/Hospital | 1 | 0 | 1 | 2006 |
12 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| GlaxoSmithKline | For profit | NDA2 | May 11, 2001 |
| SmithKline Beecham | For profit | NDA | May 11, 2001 |