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CervarixTM (GSK580299)
Cervarix is a bivalent human papillomavirus (HPV) vaccine that stimulates the immune system to produce antibodies against HPV types 16 and 18, which cause cervical cancer.
Cervarix is a bivalent human papillomavirus (HPV) vaccine that stimulates the immune system to produce antibodies against HPV types 16 and 18, which cause cervical cancer. 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 | CervarixTM (GSK580299) |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Prophylactic vaccine |
| Target | Human papillomavirus (HPV) types 16 and 18 |
| Modality | Biologic |
| Therapeutic area | Oncology / Immunology |
| Phase | Phase 3 |
Mechanism of action
Cervarix contains virus-like particles (VLPs) derived from the major capsid protein of HPV types 16 and 18, formulated with an adjuvant system (AS04) to enhance immune response. The vaccine triggers both humoral and cellular immunity, enabling the body to recognize and eliminate HPV-infected cells before malignant transformation occurs. This prevents infection with the two HPV types responsible for approximately 70% of cervical cancers.
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
- Fever
Key clinical trials
- Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years) (PHASE3)
- Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US (PHASE3)
- Safety Evaluation of a Human Papillomavirus (HPV) Vaccine in Healthy Female Control Subjects From the GSK HPV 023 Study (PHASE3)
- Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Brazil, Taiwan or Thailand (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:
- CervarixTM (GSK580299) CI brief — competitive landscape report
- CervarixTM (GSK580299) updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI