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quadrivalent human papillomavirus vaccine
The 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.
The 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 anal cancer and other HPV-related cancers.
At a glance
| Generic name | quadrivalent human papillomavirus vaccine |
|---|---|
| Also known as | Gardasil |
| Sponsor | University of Pittsburgh |
| Drug class | vaccine |
| Target | Human papillomavirus types 6, 11, 16, 18 |
| Modality | Biologic |
| Therapeutic area | Oncology / Immunology |
| 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. These VLPs are non-infectious but structurally similar to natural HPV virions, triggering a robust humoral immune response that generates neutralizing antibodies. This antibody response provides protection against infection by these HPV types, preventing cervical cancer, genital warts, and other HPV-related malignancies.
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 anal cancer and other HPV-related cancers
Common side effects
- Injection site pain
- Injection site swelling
- Injection site erythema
- Fever
- Nausea
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 |
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