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Cervarix®, GlaxoSmithKline
Cervarix®, GlaxoSmithKline is a Bivalent HPV vaccine Biologic drug developed by Cancer Prevention and Research Institute, Italy. It is currently FDA-approved 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 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®, GlaxoSmithKline |
|---|---|
| Sponsor | Cancer Prevention and Research Institute, Italy |
| Drug class | Bivalent HPV vaccine |
| Target | HPV types 16 and 18 L1 capsid protein |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Cervarix contains virus-like particles (VLPs) derived from the L1 major capsid protein of HPV types 16 and 18, the two strains most commonly associated with cervical cancer. Upon vaccination, the immune system recognizes these particles 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 persistent HPV infection that would otherwise lead to precancerous lesions and cervical cancer.
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
- FASTER-Tlalpan Study in Mexico: HPV Vaccination Impact on Cervical Cancer Screening Program (PHASE4)
- Effectiveness of Single Dose or Two Doses of Bivalent HPV Vaccine in Thailand (NA)
- Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age (PHASE3)
- Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females
- Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects (PHASE3)
- Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects (PHASE3)
- Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults (PHASE3)
- Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus Vaccine (Cervarix™) When Co-administered With GSK Biologicals' Hepatitis A Vaccine (Havrix®) in Healthy Female Adolescents Aged 9-14 Years (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®, GlaxoSmithKline CI brief — competitive landscape report
- Cervarix®, GlaxoSmithKline updates RSS · CI watch RSS
- Cancer Prevention and Research Institute, Italy portfolio CI
Frequently asked questions about Cervarix®, GlaxoSmithKline
What is Cervarix®, GlaxoSmithKline?
How does Cervarix®, GlaxoSmithKline work?
What is Cervarix®, GlaxoSmithKline used for?
Who makes Cervarix®, GlaxoSmithKline?
What drug class is Cervarix®, GlaxoSmithKline in?
What development phase is Cervarix®, GlaxoSmithKline in?
What are the side effects of Cervarix®, GlaxoSmithKline?
What does Cervarix®, GlaxoSmithKline target?
Related
- Drug class: All Bivalent HPV vaccine drugs
- Target: All drugs targeting HPV types 16 and 18 L1 capsid protein
- Manufacturer: Cancer Prevention and Research Institute, Italy — full pipeline
- Therapeutic area: All drugs in Oncology
- 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
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing