{"id":"gsk580299-cervarix","safety":{"commonSideEffects":[{"rate":"60–70","effect":"Injection site pain"},{"rate":"20–30","effect":"Injection site redness"},{"rate":"20–30","effect":"Injection site swelling"},{"rate":"10–20","effect":"Fatigue"},{"rate":"10–20","effect":"Myalgia"},{"rate":"10–20","effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Cervarix contains virus-like particles (VLPs) derived from the major capsid protein (L1) of HPV types 16 and 18, the two strains most commonly associated with cervical cancer. 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 prophylactic approach blocks the initial infection step, thereby preventing the persistent HPV infection that leads to malignant transformation.","oneSentence":"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.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:14:44.133Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of cervical cancer caused by HPV types 16 and 18"},{"name":"Prevention of cervical intraepithelial neoplasia (CIN) grades 1, 2, and 3 caused by HPV types 16 and 18"}]},"trialDetails":[{"nctId":"NCT05237947","phase":"PHASE4","title":"Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2022-03-01","conditions":"Human Papillomavirus-Related Cervical Carcinoma","enrollment":5000},{"nctId":"NCT03180034","phase":"PHASE4","title":"Comparing One or Two Doses of the Human Papillomavirus Vaccine for the Prevention of Human Papillomavirus Infection, ESCUDDO Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2017-11-29","conditions":"Human Papillomavirus Infection, Human Papillomavirus-Related Cervical Carcinoma","enrollment":27945},{"nctId":"NCT03728881","phase":"PHASE3","title":"Single Dose of Cervarix Vaccine in Girls or Three Doses of Gardasil Vaccine in Women for the Prevention of Human Papillomavirus Infection, the PRIMAVERA-ESCUDDO Trial","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2019-04-01","conditions":"Human Papillomavirus-Related Cervical Carcinoma","enrollment":1240},{"nctId":"NCT00481767","phase":"PHASE3","title":"Immunogenicity and Safety of GlaxoSmithKline (GSK) 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Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-10-04","conditions":"Infections, Papillomavirus","enrollment":34412},{"nctId":"NCT01462357","phase":"PHASE3","title":"Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-11-21","conditions":"Infections, Papillomavirus","enrollment":1079},{"nctId":"NCT01249365","phase":"PHASE3","title":"The Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-01-24","conditions":"Infections, Papillomavirus","enrollment":199},{"nctId":"NCT01190189","phase":"PHASE3","title":"Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-04-01","conditions":"Infections, Papillomavirus","enrollment":137},{"nctId":"NCT00779766","phase":"PHASE3","title":"Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-10-22","conditions":"Infections, Papillomavirus","enrollment":6081},{"nctId":"NCT00652938","phase":"PHASE3","title":"Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-04-09","conditions":"Infections, Papillomavirus","enrollment":744},{"nctId":"NCT00578227","phase":"PHASE3","title":"Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-12-15","conditions":"Infections, Papillomavirus","enrollment":814},{"nctId":"NCT01277042","phase":"PHASE3","title":"Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-02-17","conditions":"Infections, Papillomavirus","enrollment":1212},{"nctId":"NCT00549900","phase":"PHASE1","title":"A Single Centre Study to Evaluate the Safety and Immunogenicity of the Human Papillomavirus Vaccine (GSK-580299) in Chinese Females","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-12-02","conditions":"Infections, Papillomavirus","enrollment":30},{"nctId":"NCT00799825","phase":"PHASE3","title":"Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-01-01","conditions":"Infections, Papillomavirus","enrollment":346},{"nctId":"NCT00546078","phase":"PHASE2","title":"Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-01-14","conditions":"Infections, Papillomavirus","enrollment":116},{"nctId":"NCT00552279","phase":"PHASE3","title":"Immunogenicity and Safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) Vaccine 580299 in Healthy Females 15 - 25 Years of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-11-12","conditions":"Infections, Papillomavirus","enrollment":805},{"nctId":"NCT00929526","phase":"PHASE3","title":"Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-06","conditions":"Infections, Papillomavirus","enrollment":752},{"nctId":"NCT00811798","phase":"PHASE3","title":"Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) in Healthy Female Subjects.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-05","conditions":"Infections, Papillomavirus","enrollment":92},{"nctId":"NCT00689741","phase":"PHASE2","title":"Efficacy Study of HPV-16/18 Vaccine (GSK 580299) to Prevent HPV-16 and/or -18 Cervical Infection in Young Healthy Women","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2001-01","conditions":"Infections, Papillomavirus","enrollment":1113},{"nctId":"NCT02082639","phase":"PHASE3","title":"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","status":"WITHDRAWN","sponsor":"GlaxoSmithKline","startDate":"2015-02","conditions":"Infections, Papillomavirus","enrollment":""},{"nctId":"NCT02100618","phase":"PHASE3","title":"Antibody Persistence for GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) Administered in Healthy Adults and Adolescents, 6.5 Years After First Vaccination in the Primary Study","status":"WITHDRAWN","sponsor":"GlaxoSmithKline","startDate":"2015-01","conditions":"Infections, Papillomavirus","enrollment":""},{"nctId":"NCT00849381","phase":"PHASE3","title":"Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Brazil, Taiwan or Thailand","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-04","conditions":"Infections, Papillomavirus","enrollment":1239}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":384,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"GSK580299 (Cervarix)","genericName":"GSK580299 (Cervarix)","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","firstApprovalDate":"","aiSummary":"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.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}