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CervarixTM
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 | CervarixTM |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Prophylactic vaccine |
| Target | Human papillomavirus types 16 and 18 |
| 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. When administered, the vaccine triggers both humoral and cellular immune responses, generating high titers of 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
- Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls (PHASE4)
- Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age (PHASE3)
- Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine (PHASE2)
- Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects (PHASE3)
- 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 |