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Gardasil 9 Suspension for Injection
Gardasil 9 is a recombinant human papillomavirus (HPV) vaccine that stimulates the immune system to produce antibodies against nine HPV types to prevent infection and associated cancers.
Gardasil 9 is a recombinant human papillomavirus (HPV) vaccine that stimulates the immune system to produce antibodies against nine HPV types to prevent infection and associated cancers. Used for Prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58, Prevention of anal cancer caused by HPV types 16 and 18, Prevention of genital warts caused by HPV types 6 and 11.
At a glance
| Generic name | Gardasil 9 Suspension for Injection |
|---|---|
| Sponsor | Erasmus Medical Center |
| Drug class | Recombinant HPV vaccine |
| Target | Human papillomavirus L1 capsid protein (types 6, 11, 16, 18, 31, 33, 45, 52, 58) |
| Modality | Small molecule |
| Therapeutic area | Oncology / Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains virus-like particles (VLPs) derived from the L1 major capsid protein of nine HPV types (6, 11, 16, 18, 31, 33, 45, 52, and 58). 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 malignancies and benign lesions.
Approved indications
- Prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58
- Prevention of anal cancer caused by HPV types 16 and 18
- Prevention of genital warts caused by HPV types 6 and 11
- Prevention of oropharyngeal and other HPV-related cancers
Common side effects
- Injection site pain
- Injection site swelling
- Injection site erythema
- Headache
- Fever
- Nausea
Key clinical trials
- 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)
- HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini (PHASE4)
- HPV Vaccine Reduced Dose (PHASE4)
- Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts (PHASE2, PHASE3)
- A Study to Evaluate the Immunogenicity and Safety of Nonavalent Human Papillomavirus (HPV) Vaccine (PHASE3)
- Adjuvant Nonavalent HPV Vaccination in Women Treated for Vulvar HSIL (PHASE4)
- A Study to Evaluate the Immunogenicity and Safety of HPV Vaccine in Healthy Female Participants Aged 9-26 Years in China (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:
- Gardasil 9 Suspension for Injection CI brief — competitive landscape report
- Gardasil 9 Suspension for Injection updates RSS · CI watch RSS
- Erasmus Medical Center portfolio CI