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Gardasil ® (Merck & Co. Inc)
Gardasil ® (Merck & Co. Inc) is a Recombinant vaccine Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development 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.
Gardasil is a recombinant vaccine that stimulates the immune system to produce antibodies against human papillomavirus (HPV) types to prevent infection and associated cancers.
Gardasil is a recombinant vaccine that stimulates the immune system to produce antibodies against human papillomavirus (HPV) types 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 cancer and other HPV-related cancers.
At a glance
| Generic name | Gardasil ® (Merck & Co. Inc) |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Recombinant vaccine |
| Target | Human papillomavirus (HPV) types 6, 11, 16, 18 |
| Modality | Biologic |
| Therapeutic area | Oncology / Immunology |
| Phase | Phase 3 |
Mechanism of action
Gardasil contains virus-like particles (VLPs) derived from the major capsid protein of HPV types 6, 11, 16, and 18. These VLPs are non-infectious but immunogenic, triggering a humoral immune response that generates neutralizing antibodies. These antibodies prevent HPV infection of epithelial cells, thereby reducing the risk of HPV-related cancers and diseases.
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
- Headache
- Nausea
Key clinical trials
- Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) Versus Gardasil®9 in Healthy Females 18-26 Years of Age (PHASE3)
- Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age (PHASE3)
- Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease (NA)
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 ® (Merck & Co. Inc) CI brief — competitive landscape report
- Gardasil ® (Merck & Co. Inc) updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Gardasil ® (Merck & Co. Inc)
What is Gardasil ® (Merck & Co. Inc)?
How does Gardasil ® (Merck & Co. Inc) work?
What is Gardasil ® (Merck & Co. Inc) used for?
Who makes Gardasil ® (Merck & Co. Inc)?
What drug class is Gardasil ® (Merck & Co. Inc) in?
What development phase is Gardasil ® (Merck & Co. Inc) in?
What are the side effects of Gardasil ® (Merck & Co. Inc)?
What does Gardasil ® (Merck & Co. Inc) target?
Related
- Drug class: All Recombinant vaccine drugs
- Target: All drugs targeting Human papillomavirus (HPV) types 6, 11, 16, 18
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Oncology / Immunology
- Indication: Drugs for Prevention of cervical cancer caused by HPV types 16 and 18
- Indication: Drugs for Prevention of genital warts caused by HPV types 6 and 11
- Indication: Drugs for Prevention of anal cancer and other HPV-related cancers
- Compare: Gardasil ® (Merck & Co. Inc) vs similar drugs
- Pricing: Gardasil ® (Merck & Co. Inc) cost, discount & access