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Cervarix TM
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 | Cervarix TM |
|---|---|
| Also known as | HPV vaccine (GSK580299), GSK Biologicals' HPV-16/18 VLP/AS04 vaccine, GSK Biologicals' HPV vaccine (580299) |
| Sponsor | GlaxoSmithKline |
| Drug class | Prophylactic vaccine |
| Target | HPV 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 the major capsid protein (L1) of HPV types 16 and 18, the two types responsible for approximately 70% of cervical cancers. 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 prevents the establishment of persistent HPV infection, which is the primary risk factor for cervical cancer development.
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
- Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine (PHASE2)
- Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects (PHASE3)
- Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years (PHASE3)
- A Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine/Cervarix TM Vaccine in Healthy Females Aged 15-25 Years (PHASE3)
- Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects (PHASE3)
- Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women (PHASE3)
- Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects (PHASE3)
- Immunogenicity and Safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) Vaccine 580299 in Healthy Females 15 - 25 Years of Age (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:
- Cervarix TM CI brief — competitive landscape report
- Cervarix TM updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI