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GSK580299 (CervarixTM)
GSK580299 (CervarixTM) is a Recombinant HPV 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 cervical intraepithelial neoplasia (CIN) grades 1, 2, and 3 caused by HPV types 16 and 18.
Cervarix is a bivalent human papillomavirus (HPV) vaccine that stimulates immune responses against HPV types 16 and 18 to prevent cervical cancer and related precancerous lesions.
Cervarix is a bivalent human papillomavirus (HPV) vaccine that stimulates immune responses against HPV types 16 and 18 to prevent cervical cancer and related precancerous lesions. 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 (CervarixTM) |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Recombinant HPV vaccine |
| Target | Human papillomavirus types 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 HPV types 16 and 18, the two strains most commonly associated with cervical cancer. The vaccine is formulated with the AS04 adjuvant system to enhance immunogenicity and elicit robust humoral and cellular immune responses. By inducing antibodies and T-cell responses against these HPV types, the vaccine prevents infection and subsequent malignant transformation of cervical epithelial cells.
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:
- GSK580299 (CervarixTM) CI brief — competitive landscape report
- GSK580299 (CervarixTM) updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about GSK580299 (CervarixTM)
What is GSK580299 (CervarixTM)?
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Who makes GSK580299 (CervarixTM)?
What drug class is GSK580299 (CervarixTM) in?
What development phase is GSK580299 (CervarixTM) in?
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What does GSK580299 (CervarixTM) target?
Related
- Drug class: All Recombinant HPV vaccine drugs
- Target: All drugs targeting Human papillomavirus types 16 and 18 (L1 capsid protein)
- 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 cervical intraepithelial neoplasia (CIN) grades 1, 2, and 3 caused by HPV types 16 and 18
- Compare: GSK580299 (CervarixTM) vs similar drugs
- Pricing: GSK580299 (CervarixTM) cost, discount & access