human papillomavirus 9-valent vaccine, recombinant
Trade name: Gardasil 9
Approved
Dec 10, 2014
Gardasil is an HPV vaccine for use in the prevention of certain strains of human papillomavirus (HPV). It was developed by Merck & Co. High-risk human papilloma virus (hr-HPV) genital infection is the most common sexually transmitted infection among women. The HPV strains that Gardasil protects against are sexually transmitted, specifically HPV types 6, 11, 16 and 18. HPV types 16 and 18 cause an estimated 70% of cervical cancers, and are responsible for most HPV-induced anal, vulvar, vaginal, and penile cancer cases. HPV types 6 and 11 cause an estimated 90% of genital warts cases. HPV type 16 is responsible for almost 90% of HPV-positive oropharyngeal cancers, and the prevalence is higher in males than females. Though Gardasil does not treat existing infection, vaccination is still recommended for HPV-positive individuals, as it may protect against one or more different strains of the disease. — Wikipedia
Clinical trial activity
122 trials · 121 clinical orgs · 1 marketing orgs
Earliest trial started Sep 24, 2007 (NCT00543543)
Timeline
Indications
Approved for
Studied for
- Acquired Immunodeficiency Syndrome · Phase 3
- Adenocarcinoma in Situ · Phase 3
- Alphapapillomavirus · Phase 4
- Androgens · Phase 3
- Anus Neoplasms · Phase 3
- Basal Cell Carcinoma · Phase 2
- Carcinoma · Phase 4
- Carcinoma in Situ · Phase 3
- Carcinoma, Squamous Cell · Phase 3
- Cervical Intraepithelial Neoplasia · Phase 4
- Cervix Uteri · Phase 2
- Condylomata Acuminata · Phase 3
- COVID-19 · Phase 3
- Dengue · Phase 3
- Depression · Phase 4
- Drug Evaluation · Phase 4
- Drugs, Investigational · Phase 2
- Genital Diseases · Phase 3
- Head and Neck Neoplasms · Phase 1/Phase 2
- Healthy Volunteers · Phase 3
- Hematopoietic Stem Cell Transplantation · Phase 4
- Hepatitis B · Phase 4
- HIV · Phase 4
- HIV Infections · Phase 4
- Human papillomavirus 16 · Phase 4
- Human Papillomavirus Viruses · Phase 2
- Immunization · Phase 4
- Infections · Phase 4
- Inflammatory Bowel Diseases · Phase 4
- Keratosis, Actinic · Phase 2
- Kidney Transplantation · Phase 4
- Leukemia, Myeloid, Acute · Phase 2
- Liver Neoplasms · Phase 4
- Lung Diseases · Early Phase 1
- Lymphoma · Phase 4
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Measles · Phase 4
- Meningococcal Infections · Phase 3
- Mental Health · Phase 4
- Mumps · Phase 4
- Myelodysplastic Syndromes · Phase 2
- Neoplasms · Phase 4
- Neoplasms, Unknown Primary · Phase 1/Phase 2
- Papilloma · Phase 3
- Papillomaviridae · Phase 4
- Papillomavirus Infections · Phase 4
- Papillomavirus Vaccines · Phase 4
- Penile Neoplasms · Phase 3
- Pharmacological and Toxicological Phenomena · Phase 3
- Renal Insufficiency, Chronic · Phase 4
- Rubella · Phase 4
- Serology · Phase 4
- Thrombocytopenia · Phase 2
- Transgender Persons · Phase 2
- Transplants · Phase 3
- Uterine Cervical Dysplasia · Phase 4
- Uterine Cervical Neoplasms · Phase 4
- Vaginal Neoplasms · Phase 3
- Vulvar Diseases · Phase 4
- Vulvar Neoplasms · Phase 4
- Warts · Phase 2/Phase 3
Mechanism of action
- Human papillomavirusImmunity, active
Human papillomavirus immunity, active
Approval history
- approvedDec 10, 2014
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaGardasil ↗
- WikipediaHPV vaccine ↗
Also known as
- 9-valent hpv vaccine
- gardasil 9
- gardasil 9
- human papillomavirus 9-valent vaccine, recombinant
- human papillomavirus 9-valent vaccine, recombinant
- human papillomavirus vaccine
- human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed)
- nonavalent hpv vaccine
- recombinant human papillomavirus nonavalent vaccine
- v503
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07303751 | Phase 2 | Feb 1, 2026 | University of Barcelona |
| NCT06786429 | Phase 4 | Jan 31, 2026 | Eunice Dube, National Cancer Institute (NCI), National University of Science and Technology, Zimbabwe |
| NCT07256912 | Phase 4 | Jan 15, 2026 | International Agency for Research on Cancer |
| NCT07281677 | Phase 4 | Dec 20, 2025 | Government of China |
| NCT07224477 | Phase 2 | Dec 5, 2025 | Merck |
| NCT07156084 | Phase 4 | Sep 23, 2025 | Canadian Immunization Research Network |
| NCT06793410 | Phase 2 | May 12, 2025 | Vastra Gotaland Region |
| NCT06959563 | Early Phase 1 (Phase 1) | Apr 28, 2025 | Medicine Invention Design, Inc, UnitedHealth Group |
| NCT06866574 | Phase 3 | Apr 11, 2025 | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Fudan University, Government of China, Xiamen University |
| NCT06799494 | Phase 4 | Mar 31, 2025 | Emory University, Merck |
| NCT06756269 | Phase 2 | Jan 15, 2025 | Government of China, Shanghai Bovax Biotechnology Co., Ltd. |
| NCT06681636 | Phase 2 | Dec 14, 2024 | Government of Vietnam, Murdoch University |
| NCT06688058 | Phase 1 | Dec 12, 2024 | Merck |
| NCT06623409 | Phase 1 | Nov 4, 2024 | Merck |
| NCT06624839 | Phase 2 | Oct 31, 2024 | University of Maryland |
| NCT06658405 | Phase 2 | Oct 31, 2024 | University of Lille |
| NCT06588257 | Phase 4 | Oct 9, 2024 | Fundacion Huesped, Merck |
| NCT06436274 | Phase 4 | Sep 30, 2024 | Botswana Harvard Aids Institute, Government of Rwanda, Harvard University, Karolinska Institute, National Cancer Institute (NCI), University of the Witwatersrand, University of Washington |
| NCT06536855 | Phase 4 | Sep 1, 2024 | Karolinska Institute, Merck, Rwanda Biomedical Centre |
| NCT06465914 | Phase 3 | Jul 11, 2024 | Fudan University, Government of China, Shanghai Bovax Biotechnology Co., Ltd. |
Organizations
Research & Development (121)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Merck | For profit | 43 | 25 | 4 | 2007 |
| Government of China | Government | 17 | 2 | 4 | 2019 |
| National Cancer Institute (NCI) | Government | 12 | 5 | 4 | 2016 |
| Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | For profit | 7 | 1 | 4 | 2019 |
| Shanghai Bovax Biotechnology Co., Ltd. | Government | 7 | 7 | 3 | 2018 |
| University of Washington | Academic/Hospital | 6 | 5 | 2 | 2017 |
| Xiamen University | Academic/Hospital | 6 | 6 | 3 | 2019 |
| Beijing Health Guard Biotechnology, Inc | For profit | 5 | 5 | 3 | 2019 |
| Karolinska Institute | Academic/Hospital | 4 | 0 | 2 | 2017 |
| University of the Witwatersrand | Academic/Hospital | 3 | 1 | 3 | 2014 |
| Boston University | Academic/Hospital | 2 | 2 | 2 | 2020 |
| Cornell University | Academic/Hospital | 2 | 1 | 2 | 2014 |
| Emory University | Academic/Hospital | 2 | 1 | 2 | 2023 |
| Fudan University | Academic/Hospital | 2 | 0 | 1 | 2024 |
| International Agency for Research on Cancer | Academic/Hospital | 2 | 2 | 2 | 2023 |
| Laval University | Academic/Hospital | 2 | 2 | 1 | 2015 |
| Sanofi-Aventis | For profit | 2 | 1 | 1 | 2011 |
| Shanghai Zerun Biotechnology Co.,Ltd | For profit | 2 | 2 | 2 | 2019 |
| Sinocelltech Ltd. | For profit | 2 | 2 | 2 | 2021 |
| State of Texas | Government | 2 | 0 | 1 | 2019 |
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Merck | For profit | NDA | Oct 10, 2014 |