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Comparator: Gardasil
Gardasil is a recombinant quadrivalent human papillomavirus (HPV) vaccine that stimulates the immune system to produce antibodies against HPV types 6, 11, 16, and 18.
Gardasil is a recombinant quadrivalent human papillomavirus (HPV) vaccine that stimulates the immune system to produce antibodies against HPV types 6, 11, 16, and 18. 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, and vaginal cancers caused by HPV types 16 and 18.
At a glance
| Generic name | Comparator: Gardasil |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Recombinant quadrivalent HPV vaccine |
| Target | Human papillomavirus (HPV) types 6, 11, 16, 18 |
| Modality | Biologic |
| Therapeutic area | Oncology / Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains virus-like particles (VLPs) derived from the major capsid protein of four HPV types. These VLPs are non-infectious and trigger a humoral immune response, generating neutralizing antibodies that prevent infection by these HPV strains. This prevents the development of HPV-related cancers and genital warts caused by these viral types.
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, and vaginal cancers caused by HPV types 16 and 18
Common side effects
- Injection site pain
- Injection site swelling
- Injection site erythema
- Fever
- Headache
- Nausea
Key clinical trials
- A Trial to Evaluate Tolerability and Immunogenicity of V540D in Healthy Adults (V540D-004) (PHASE1)
- A Clinical Study of V540A in Healthy Female Participants (V540A-005) (PHASE2)
- Safety and Immunogenicity of V540B in Healthy Adults (V540B-002). (PHASE1)
- Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study (PHASE4)
- Phase 3 Trial of a Bivalent Human Papilloma Virus (HPV) Vaccine (Cecolin®) in Young Girls (PHASE3)
- Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females (PHASE3)
- Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041) (PHASE3)
- Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) (PHASE3)
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:
- Comparator: Gardasil CI brief — competitive landscape report
- Comparator: Gardasil updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI