human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant
Trade name: Gardasil
Approved
Jun 8, 2006
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
125 trials · 132 clinical orgs · 1 marketing orgs
Earliest trial started May 1, 2000 (NCT00365716)
Timeline
Indications
Approved for
Studied for
- Acne Vulgaris · Phase 2
- Adenocarcinoma in Situ · Phase 4
- Adolescent · Phase 1
- Alphapapillomavirus · Phase 4
- Androgens · Phase 3
- Anus Neoplasms · Phase 2
- Arthritis, Juvenile · Phase 3
- Autoimmune Diseases · Phase 3
- Bone Marrow Transplantation · Phase 3
- Cancer Survivors · Phase 2
- Carcinoma · Phase 4
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Carcinoma, Verrucous · Phase 3
- Cervical Intraepithelial Neoplasia · Phase 4
- Condylomata Acuminata · Phase 4
- Diphtheria · Phase 3
- Drugs, Investigational · Phase 2
- Genital Diseases, Female · Phase 2
- Genital Neoplasms, Female · Phase 3
- Healthy Volunteers · Phase 4
- Hematopoietic Stem Cell Transplantation · Phase 1
- HIV · Phase 4
- HIV Infections · Phase 3
- Human papillomavirus 16 · Phase 4
- Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 · Phase 4
- Humans · Phase 3
- Immune System Diseases · Phase 2
- Infections · Phase 4
- Inflammatory Bowel Diseases · Phase 3
- Kidney Transplantation · Phase 4
- Liver Transplantation · Phase 4
- Lung Diseases · Phase 3
- Lupus Erythematosus, Systemic · Phase 4
- Meningitis · Phase 3
- Meningitis, Meningococcal · Phase 4
- Meningococcal Infections · Phase 2
- Meningococcal Vaccines · Phase 2
- Neoplasm Metastasis · Phase 2
- Neoplasms · Phase 4
- Neoplasms, Glandular and Epithelial · Phase 3
- Oropharyngeal Neoplasms · Phase 2
- Papilloma · Phase 4
- Papillomaviridae · Phase 3
- Papillomavirus Infections · Phase 4
- Papillomavirus Vaccines · Phase 4
- Penile Neoplasms · Phase 2
- Pharmacological and Toxicological Phenomena · Phase 1
- Poliomyelitis · Phase 3
- Precancerous Conditions · Phase 4
- Sexually Transmitted Diseases · Phase 2
- Tetanus · Phase 3
- Transplantation · Phase 2
- Transplants · Phase 3
- Uterine Cervical Dysplasia · Phase 1
- Uterine Cervical Neoplasms · Phase 4
- Vaccine-Preventable Diseases · Phase 4
- Vaccines · Phase 2
- Vaginal Neoplasms · Phase 3
- Vulvar Neoplasms · Phase 3
- Warts · Phase 4
- Whooping Cough · Phase 3
Mechanism of action
- Human papillomavirusImmunity, active
Human papillomavirus immunity, active
Approval history
- approvedJun 8, 2006
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaGardasil ↗
- NCATS23CVL7WF4J ↗
- WikipediaHPV vaccine ↗
Also known as
- 4-valent hpv vaccine
- both doses late
- garaisil
- gardasil
- gardasil
- gardasil
- hpv vaccine
- human papillomavirus 6,11,16,18 vaccine
- human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant
- human papillomavirus quadrivalent vaccine
- human papillomavirus type 11 l1 protein /human papillomavirus type 16 l1 protein /human papillomavirus type 18 l1 protein/human papillomavirus type 6 l1 protein
- human papillomavirus type 6 l1 protein / human papillomavirus type 11 l1 protein / human papillomavirus type 16 l1 protein / human papillomavirus type 18 l1 protein
- human papillomavirus vaccine l1, type 6,11,16,18
- human papillomavirus vaccine l1, type 6,11,16,18
- quadrivalen human papillomavirus vaccine
- quadrivalent human papillomavirus vaccine
- silgard
- silgard
- tetravalent vaccine
- v501
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06650956 | N/A | Nov 30, 2024 | Health Poverty Action |
| NCT06632912 | Phase 3 | Oct 31, 2024 | Chengdu Institute of Biological Products Co.,Ltd., National Vaccine and Serum Institute, China |
| NCT06281119 | Phase 3 | Jun 30, 2024 | Bill and Melinda Gates Foundation, Serum Institute of India Pvt. Ltd. |
| NCT06142461 | Phase 2 | Jan 31, 2024 | National Cancer Institute (NCI), National Institutes of Health (NIH), PharmaJet, Inc. |
| NCT05672966 | Phase 1 | Aug 1, 2023 | Government of China, Novotech, Wuhan BravoVax Co., Ltd. |
| NCT05799144 | Phase 2 | May 16, 2023 | Vanderbilt University |
| NCT05584332 | Phase 3 | Nov 15, 2022 | Shanghai Bovax Biotechnology Co., Ltd. |
| NCT05761002 | N/A | Jun 1, 2022 | Zagazig University |
| NCT05435209 | Phase 4 | May 25, 2022 | Merck, University of Washington |
| NCT05031078 | Phase 4 | Nov 30, 2021 | Emory University |
| NCT04953130 | Phase 4 | Nov 30, 2021 | Government of Tanzania, Institut Català d'Oncologia, Karolinska Institute, University of Cambridge, University of London, University of York |
| NCT05060484 | Phase 2 | Oct 19, 2021 | Government of China, Sinocelltech Ltd. |
| NCT04921111 | Phase 1 | Jul 2, 2021 | Sinocelltech Ltd. |
| NCT04508309 | Phase 3 | Dec 31, 2020 | Agogo Presbyterian Hospital, Ghana, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., International Center for Diarrheal Disease Research, Leidos, PATH, The EMMES Corporation |
| NCT05668572 | Phase 3 | Dec 5, 2020 | Beijing Health Guard Biotechnology, Inc |
| NCT05383625 | Phase 3 | Sep 1, 2020 | Zagazig University |
| NCT04425291 | Phase 3 | May 28, 2020 | Shanghai Bovax Biotechnology Co., Ltd. |
| NCT05694728 | Phase 2 | May 23, 2020 | Beijing Health Guard Biotechnology, Inc, Government of China |
| NCT04422366 | Phase 3 | Apr 28, 2020 | Shanghai Bovax Biotechnology Co., Ltd. |
| NCT04096911 | Phase 2 | Jul 31, 2019 | Innovent Biologics (Suzhou) Co. Ltd., Nanjing Medical University |
Organizations
Research & Development (132)
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Merck | For profit | NDA | Jun 8, 2006 |