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V503
V503 is a vaccine designed to prevent human papillomavirus (HPV) infection.
V503 is a vaccine designed to prevent human papillomavirus (HPV) infection. Used for Prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
At a glance
| Generic name | V503 |
|---|---|
| Also known as | GARDASIL®9 (HPV 9-valent vaccine [recombinant, adsorbed]); HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58, 9vHPV vaccine, SILGARD®9, GARDASIL™9 |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | vaccine |
| Modality | Biologic |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
V503 works by introducing antigens from multiple HPV types, stimulating the immune system to produce antibodies that can neutralize these viruses before they cause infection and potentially lead to cervical cancer or other HPV-related diseases.
Approved indications
- Prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Common side effects
- Injection site pain
- Fatigue
- Headache
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 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076) (PHASE3)
- Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064) (PHASE3)
- Safety and Immunogenicity of V540B in Healthy Adults (V540B-002). (PHASE1)
- Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066) (PHASE3)
- Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049) (PHASE3)
- Immunobridging Study of 9- Valent Human Papillomavirus (9vHPV) Vaccine (V503) in Chinese Females 9 to 45 Years of Age (V503-024) (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:
- V503 CI brief — competitive landscape report
- V503 updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI