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GSK580299, GSK Biological's HPV vaccine
GSK580299, GSK Biological's HPV vaccine is a Recombinant HPV vaccine Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Prevention of cervical cancer and precancerous lesions caused by HPV, Prevention of other HPV-related cancers (anal, oropharyngeal, vulvar, vaginal). Also known as: CervarixTM.
GSK580299 is an HPV vaccine that stimulates the immune system to produce antibodies and cellular immunity against human papillomavirus types associated with cervical cancer and other HPV-related malignancies.
GSK580299 is an HPV vaccine that stimulates the immune system to produce antibodies and cellular immunity against human papillomavirus types associated with cervical cancer and other HPV-related malignancies. Used for Prevention of cervical cancer and precancerous lesions caused by HPV, Prevention of other HPV-related cancers (anal, oropharyngeal, vulvar, vaginal).
At a glance
| Generic name | GSK580299, GSK Biological's HPV vaccine |
|---|---|
| Also known as | CervarixTM |
| Sponsor | GlaxoSmithKline |
| Drug class | Recombinant HPV vaccine |
| Target | Human papillomavirus (HPV) virus-like particles |
| Modality | Biologic |
| Therapeutic area | Oncology / Immunology |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains recombinant HPV virus-like particles (VLPs) that mimic the structure of the virus without containing infectious genetic material. Upon administration, these VLPs trigger both humoral (antibody) and cell-mediated immune responses, enabling the body to recognize and eliminate HPV-infected cells before malignant transformation occurs. This preventive approach targets multiple high-risk HPV types to reduce the incidence of HPV-associated cancers.
Approved indications
- Prevention of cervical cancer and precancerous lesions caused by HPV
- Prevention of other HPV-related cancers (anal, oropharyngeal, vulvar, vaginal)
Common side effects
- Injection site pain or swelling
- Headache
- Fatigue
- Myalgia
- Fever
Key clinical trials
- Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US (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, GSK Biological's HPV vaccine CI brief — competitive landscape report
- GSK580299, GSK Biological's HPV vaccine updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about GSK580299, GSK Biological's HPV vaccine
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Related
- Drug class: All Recombinant HPV vaccine drugs
- Target: All drugs targeting Human papillomavirus (HPV) virus-like particles
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Oncology / Immunology
- Indication: Drugs for Prevention of cervical cancer and precancerous lesions caused by HPV
- Indication: Drugs for Prevention of other HPV-related cancers (anal, oropharyngeal, vulvar, vaginal)
- Also known as: CervarixTM
- Compare: GSK580299, GSK Biological's HPV vaccine vs similar drugs
- Pricing: GSK580299, GSK Biological's HPV vaccine cost, discount & access