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GSK580299 (Cervarix)
Cervarix is a bivalent human papillomavirus (HPV) vaccine that stimulates the immune system to produce antibodies against HPV types 16 and 18, preventing infection and cervical cancer development.
Cervarix is a bivalent human papillomavirus (HPV) vaccine that stimulates the immune system to produce antibodies against HPV types 16 and 18, preventing infection and cervical cancer development. Used for Prevention of cervical cancer caused by HPV types 16 and 18, Prevention of cervical intraepithelial neoplasia (CIN) grades 1, 2, and 3 caused by HPV types 16 and 18.
At a glance
| Generic name | GSK580299 (Cervarix) |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Prophylactic vaccine |
| Target | HPV type 16 and 18 L1 capsid protein |
| Modality | Biologic |
| Therapeutic area | Oncology / Immunology |
| Phase | Phase 3 |
Mechanism of action
Cervarix contains virus-like particles (VLPs) derived from the major capsid protein (L1) of HPV types 16 and 18, the two strains most commonly associated with cervical cancer. Upon vaccination, the immune system recognizes these VLPs as foreign antigens and generates a robust humoral and cellular immune response, producing neutralizing antibodies that prevent viral infection of cervical epithelial cells. This prophylactic approach blocks the initial infection step, thereby preventing the persistent HPV infection that leads to malignant transformation.
Approved indications
- Prevention of cervical cancer caused by HPV types 16 and 18
- Prevention of cervical intraepithelial neoplasia (CIN) grades 1, 2, and 3 caused by HPV types 16 and 18
Common side effects
- Injection site pain
- Injection site redness
- Injection site swelling
- Fatigue
- Myalgia
- Headache
Key clinical trials
- Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial (PHASE4)
- Comparing One or Two Doses of the Human Papillomavirus Vaccine for the Prevention of Human Papillomavirus Infection, ESCUDDO Study (PHASE4)
- 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)
- Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (GSK580299) in Healthy Female Subjects 10-25 Years of Age. (PHASE3)
- Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old (PHASE3)
- Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects. (PHASE3)
- Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents (PHASE4)
- Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females (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:
- GSK580299 (Cervarix) CI brief — competitive landscape report
- GSK580299 (Cervarix) updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI