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quadrivalent HPV vaccine
The quadrivalent HPV vaccine stimulates the immune system to produce antibodies against four types of human papillomavirus (HPV-6, 11, 16, and 18) to prevent infection and associated cancers.
The quadrivalent HPV vaccine stimulates the immune system to produce antibodies against four types of human papillomavirus (HPV-6, 11, 16, and 18) to prevent infection and associated cancers. 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, vulvar, vaginal, and oropharyngeal cancers associated with HPV types 6, 11, 16, and 18.
At a glance
| Generic name | quadrivalent HPV vaccine |
|---|---|
| Also known as | CERVAVAC single dose, Gardasil-4 vaccine, Gardasil, 4 HPV vaccine, q HPV vaccine |
| Sponsor | International Agency for Research on Cancer |
| Drug class | Recombinant virus-like particle vaccine |
| Target | HPV types 6, 11, 16, 18 (L1 major capsid protein) |
| Modality | Biologic |
| Therapeutic area | Oncology / Immunology |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains virus-like particles (VLPs) derived from the major capsid protein of four HPV types. Upon administration, these VLPs trigger a humoral immune response that generates neutralizing antibodies against the targeted HPV strains. This prevents viral infection of epithelial cells and reduces the risk of HPV-related cancers, particularly cervical cancer, and other anogenital and oropharyngeal 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, vulvar, vaginal, and oropharyngeal cancers associated with HPV types 6, 11, 16, and 18
Common side effects
- Injection site pain, swelling, or erythema
- Fever
- Headache
- Myalgia
- 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)
- Prospective Trial of Vaccine Responses in Childhood Cancer Survivors (PHASE2)
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:
- quadrivalent HPV vaccine CI brief — competitive landscape report
- quadrivalent HPV vaccine updates RSS · CI watch RSS
- International Agency for Research on Cancer portfolio CI