{"id":"gsk580299-cervarixtm","safety":{"commonSideEffects":[{"rate":"~70%","effect":"Injection site pain"},{"rate":"~25%","effect":"Injection site redness"},{"rate":"~20%","effect":"Injection site swelling"},{"rate":"~18%","effect":"Fatigue"},{"rate":"~13%","effect":"Myalgia"},{"rate":"~13%","effect":"Headache"},{"rate":"~12%","effect":"Fever"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Cervarix contains virus-like particles (VLPs) derived from HPV types 16 and 18, the two strains most commonly associated with cervical cancer. The vaccine is formulated with the AS04 adjuvant system to enhance immunogenicity and elicit robust humoral and cellular immune responses. By inducing antibodies and T-cell responses against these HPV types, the vaccine prevents infection and subsequent malignant transformation of cervical epithelial cells.","oneSentence":"Cervarix is a bivalent human papillomavirus (HPV) vaccine that stimulates immune responses against HPV types 16 and 18 to prevent cervical cancer and related precancerous lesions.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:14:45.140Z","_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":"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":"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":"NCT01418937","phase":"PHASE3","title":"Safety Evaluation of a Human Papillomavirus (HPV) Vaccine in Healthy Female Control Subjects From the GSK HPV 023 Study","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-05-29","conditions":"Infections, Papillomavirus","enrollment":164},{"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":1,"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 (CervarixTM)","genericName":"GSK580299 (CervarixTM)","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","firstApprovalDate":"","aiSummary":"Cervarix is a bivalent human papillomavirus (HPV) vaccine that stimulates immune responses against HPV types 16 and 18 to prevent cervical cancer and related precancerous lesions. 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}}