hepatitis a vaccine, inactivated
Trade name: vaqta
Vaccineapproved
Approved
Feb 22, 1995
Hepatitis A vaccine is a vaccine that prevents hepatitis A. It is effective in around 95% of cases and lasts for at least twenty years and possibly a person's entire life. If given, two doses are recommended beginning after the age of one. It is given by injection into a muscle. The first hepatitis A vaccine was approved in the European Union in 1991, and the United States in 1995. It is on the World Health Organization's List of Essential Medicines. — Wikipedia
Clinical trial activity
124 trials · 89 clinical orgs · 2 marketing orgs
Phase 1
4
Phase 2
65
Phase 3
49
Phase 4
46
Earliest trial started Sep 1, 1996 (NCT00139113)
Timeline
1990s
- Feb 22, 1995
Earliest FDA Approval
- Feb 22, 1995
GlaxoSmithKline — NDA Secondary Org
2000s
- Jan 1, 2002
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2003
GlaxoSmithKline — Earliest Phase 3 Sponsor(trial)
2010s
- Jan 1, 2014
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Studied for
- Breast Neoplasms · Phase 1
- Chickenpox · Phase 4
- Colorectal Neoplasms · Phase 1
- Coronavirus · Phase 2
- COVID-19 · Phase 4
- Dengue · Phase 3
- Dengue Virus · Phase 2
- Diphtheria · Phase 4
- Encephalitis · Phase 4
- Encephalitis, Japanese · Phase 3
- Fibrosis · Phase 4
- Haemophilus influenzae type b · Phase 3
- Healthy Volunteers · Phase 4
- Hepatitis A · Phase 4
- Hepatitis A Vaccines · Phase 3
- Hepatitis A virus · Phase 4
- Hepatitis B · Phase 4
- Herpes Simplex · Phase 3
- HIV · Phase 4
- HIV Infections · Phase 4
- Immune System Diseases · Phase 4
- Influenza, Human · Phase 4
- Lung Diseases · Phase 1
- Malaria · Phase 2
- Malaria, Falciparum · Phase 2
- Measles · Phase 4
- Measles-Mumps-Rubella Vaccine · Phase 3
- Meningitis, Meningococcal · Phase 3
- Meningococcal Infections · Phase 4
- Meningococcal Vaccines · Phase 3
- Mumps · Phase 4
- Neisseria meningitidis · Phase 3
- Papillomavirus Infections · Phase 3
- Paratyphoid Fever · Phase 4
- Pertussis Vaccine · Phase 4
- Pneumococcal Infections · Phase 3
- Pneumococcal Vaccines · Phase 3
- Pneumonia · Phase 3
- Pneumonia, Pneumococcal · Phase 4
- Precancerous Conditions · Phase 3
- Primary Immunodeficiency Diseases · Phase 4
- Rheumatic Diseases · Phase 4
- Rubella · Phase 4
- SARS-CoV-2 · Phase 2
- Severe Acute Respiratory Syndrome · Phase 2
- Severe Dengue · Phase 3
- Streptococcal Infections · Phase 3
- Streptococcus pneumoniae · Phase 3
- Tetanus · Phase 4
- Typhoid Fever · Phase 4
- Urinary Bladder Neoplasms · Phase 1
- Uterine Cervical Neoplasms · Phase 3
- Vaccination · Phase 4
- Vaccine-Preventable Diseases · Phase 3
- Vaccines · Phase 4
- Yellow Fever · Phase 3
Mechanism of action
- Hepatitis A virusImmunity, active
Hepatitis A virus immunity, active
Approval history
- approvedFeb 22, 1995
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaHepatitis A vaccine ↗
Also known as
- avaxim
- havrix
- havrix
- healive
- hepatitis a-b vaccine
- hepatitis a (control)
- hepatitis a inactivated virus vaccine
- hepatitis a vaccine
- hepatitis a vaccine
- hepatitis a vaccine, inactivated
- hepatitis a vaccine, inactivated
- hepatitis a vaccine, inactivated, nuclease purified
- hepatitis a virus vaccine
- hepatits a vaccine
- inactivated hav vaccine, lu8 strain
- inactivated hav vaccine, tz84 strain
- inactivated hepatitis a vaccine
- inactivated hep a vaccine
- twinrix
- twinrix
- vaqta
- vaqta
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07183371 | Phase 2 | Nov 30, 2025 | European and Developing Countries Clinical Trials Partnership (EDCTP), European Vaccine Initiative (EVI), Heidelberg, Germany, Government of Germany, Institut et Haute école de la Santé, La Source, University of Oxford |
| NCT06978621 | Phase 3 | May 25, 2025 | Chiangmai University |
| NCT06855160 | Phase 3 | Apr 17, 2025 | GlaxoSmithKline |
| NCT06806137 | Phase 3 | Mar 5, 2025 | GlaxoSmithKline |
| NCT06824181 | Phase 3 | Feb 27, 2025 | Sanofi |
| NCT06824194 | Phase 3 | Feb 18, 2025 | Sanofi |
| NCT06740630 | Phase 3 | Dec 17, 2024 | GlaxoSmithKline |
| NCT06693895 | Phase 3 | Nov 19, 2024 | GlaxoSmithKline |
| NCT06298708 | Phase 3 | Apr 27, 2024 | Chiangmai University |
| NCT06277882 | Phase 4 | Feb 29, 2024 | Mahidol University |
| NCT06184230 | Phase 4 | Jan 31, 2024 | Best Healthcare Inc. |
| NCT06576024 | Phase 4 | Dec 19, 2023 | Sinovac Biotech Co., Ltd |
| NCT06058416 | Phase 4 | Oct 24, 2023 | Sinovac Biotech Co., Ltd |
| NCT05794230 | Phase 3 | Mar 27, 2023 | Sanofi-Aventis |
| NCT05613127 | Phase 3 | Dec 31, 2022 | Boryung Pharmaceutical Company |
| NCT05543642 | Phase 4 | Oct 5, 2022 | Oregon Health and Science University |
| NCT05084508 | Phase 2 | Jan 4, 2022 | GlaxoSmithKline, IQVIA |
| NCT05012787 | Phase 3 | Sep 13, 2021 | Clover Biopharmaceuticals |
| NCT04953325 | Phase 4 | Jul 9, 2021 | Government of China, Sinovac Biotech Co., Ltd |
| NCT05526820 | Phase 4 | Apr 8, 2021 | Government of China, Sinovac Biotech Co., Ltd |
Showing 20 of 124 trials
Page 1 / 7
Organizations
Research & Development (89)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 47 | 41 | 3 | 1996 |
| Sanofi | For profit | 10 | 10 | 3 | 2006 |
| Government of China | Government | 8 | 1 | 1 | 2006 |
| Sinovac Biotech Co., Ltd | For profit | 8 | 7 | 1 | 2006 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 6 | 5 | 3 | 1999 |
| Merck | For profit | 5 | 5 | 2 | 2006 |
| Sanofi-Aventis | For profit | 5 | 2 | 3 | 2008 |
| Boryung Pharmaceutical Company | For profit | 3 | 3 | 1 | 2017 |
| Crucell | For profit | 3 | 3 | 3 | 2004 |
| Novartis | For profit | 3 | 3 | 2 | 2007 |
| Centers for Disease Control and Prevention (CDC) | Government | 2 | 2 | 2 | 1996 |
| Chiangmai University | Academic/Hospital | 2 | 2 | 1 | 2024 |
| China National Biotec Group Co., Ltd | For profit | 2 | 2 | 1 | 2017 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 2 | 1 | 1 | 2011 |
| Dalhousie University | Academic/Hospital | 2 | 2 | 2 | 2015 |
| Karolinska Institute | Academic/Hospital | 2 | 0 | 1 | 2009 |
| National Cancer Institute (NCI) | Government | 2 | 1 | 2 | 2011 |
| National Institute of Mental Health (NIMH) | Government | 2 | 0 | 1 | 2004 |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Government | 2 | 0 | 1 | 2004 |
| National Institute on Drug Abuse (NIDA) | Government | 2 | 0 | 1 | 2004 |
89 organizations
Page 1 / 5
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| GlaxoSmithKline | For profit | NDA2 | Feb 22, 1995 |
| Merck | For profit | NDA | Mar 29, 1986 |