Last reviewed · How we verify
Human papillomavirus quadrivalent vaccine
This vaccine stimulates the immune system to produce antibodies against four types of human papillomavirus (HPV types 6, 11, 16, and 18) to prevent infection and associated diseases.
This vaccine stimulates the immune system to produce antibodies against four types of human papillomavirus (HPV types 6, 11, 16, and 18) to prevent infection and associated diseases. Used for Prevention of cervical cancer caused by HPV types 16 and 18, Prevention of genital warts caused by HPV types 6 and 11, Prevention of other HPV-related cancers (anal, oropharyngeal, vulvar, vaginal).
At a glance
| Generic name | Human papillomavirus quadrivalent vaccine |
|---|---|
| Also known as | Gardasil |
| Sponsor | University of Alberta |
| Drug class | Recombinant virus-like particle vaccine |
| Target | Human papillomavirus types 6, 11, 16, and 18 (L1 capsid protein) |
| Modality | Biologic |
| Therapeutic area | Oncology / Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
The quadrivalent HPV vaccine contains virus-like particles (VLPs) derived from the major capsid protein of four HPV types. When administered, these VLPs trigger a humoral immune response that generates neutralizing antibodies against these HPV types, preventing viral infection of epithelial cells and reducing the risk of HPV-related cancers and genital warts.
Approved indications
- Prevention of cervical cancer caused by HPV types 16 and 18
- Prevention of genital warts caused by HPV types 6 and 11
- Prevention of other HPV-related cancers (anal, oropharyngeal, vulvar, vaginal)
Common side effects
- Injection site pain
- Injection site swelling
- Injection site erythema
- Fever
- Nausea
- Dizziness
Key clinical trials
- A Trial to Establish Non-inferiority of Immunogenicity of a Single-dose of CERVAVAC® Quadrivalent HPV Vaccine Compared to the Gardasil® Quadrivalent Vaccine Among Girls and Boys Aged 9 to 14 Years and in Girls/Women Aged 15 to 20 Years in Zambia (PHASE4)
- Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts (PHASE3)
- Phase IIIb Clinical Trial of Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) for Age/Immunization Schedule Bridging (PHASE3)
- Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents (PHASE3)
- Single Dose of Cervarix Vaccine in Girls or Three Doses of Gardasil Vaccine in Women for the Prevention of Human Papillomavirus Infection, the PRIMAVERA-ESCUDDO Trial (PHASE3)
- Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015) (PHASE3)
- Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old (EARLY_PHASE1)
- Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape: