{"id":"hpv-16-18-l1-as04","safety":{"commonSideEffects":[{"rate":"60–70","effect":"Injection site pain/soreness"},{"rate":"20–30","effect":"Injection site erythema"},{"rate":"15–25","effect":"Injection site swelling"},{"rate":"10–20","effect":"Fatigue"},{"rate":"10–15","effect":"Myalgia"},{"rate":"10–15","effect":"Headache"},{"rate":"5–10","effect":"Fever"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"HPV-16/18 L1/AS04 is a recombinant protein vaccine containing virus-like particles (VLPs) of HPV types 16 and 18 combined with the AS04 adjuvant system (aluminum hydroxide and MPL). The vaccine triggers both humoral and cell-mediated immune responses against the major capsid protein (L1), enabling the body to neutralize and clear HPV infection before malignant transformation occurs.","oneSentence":"This vaccine stimulates the immune system to produce antibodies and cellular immunity against HPV-16 and HPV-18 L1 capsid proteins, preventing infection and cervical cancer development.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:47:57.017Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of cervical cancer caused by HPV-16 and HPV-18"},{"name":"Prevention of cervical intraepithelial neoplasia (CIN) grades 2 and 3"}]},"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":"NCT03438006","phase":"","title":"A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2018-05-31","conditions":"Cervical Intraepithelial Neoplasia","enrollment":3016},{"nctId":"NCT00481767","phase":"PHASE3","title":"Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (GSK580299) in Healthy Female Subjects 10-25 Years of Age.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-10-01","conditions":"Human Papillomavirus (HPV) Infection","enrollment":676},{"nctId":"NCT03105856","phase":"PHASE4","title":"FASTER-Tlalpan Study in Mexico: HPV Vaccination Impact on Cervical Cancer Screening Program","status":"COMPLETED","sponsor":"Instituto Nacional de Salud Publica, Mexico","startDate":"2017-01-03","conditions":"Cervical Intraepithelial Neoplasia, HPV-Related Cervical Carcinoma","enrollment":3000},{"nctId":"NCT01381575","phase":"PHASE3","title":"Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-06-29","conditions":"Infections, Papillomavirus","enrollment":1447},{"nctId":"NCT03747770","phase":"NA","title":"Effectiveness of Single Dose or Two Doses of Bivalent HPV Vaccine in Thailand","status":"UNKNOWN","sponsor":"International Vaccine Institute","startDate":"2018-12-17","conditions":"Healthy","enrollment":18000},{"nctId":"NCT01627561","phase":"PHASE3","title":"Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-10-15","conditions":"Infections, Papillomavirus","enrollment":148},{"nctId":"NCT00423046","phase":"PHASE3","title":"Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-01-24","conditions":"Infections, Papillomavirus, Papillomavirus Vaccines","enrollment":1106},{"nctId":"NCT00250276","phase":"PHASE3","title":"Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-10-28","conditions":"Infections, Papillomavirus, Papillomavirus Vaccines","enrollment":798},{"nctId":"NCT00294047","phase":"PHASE3","title":"Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-02-16","conditions":"Infections, Papillomavirus, Papillomavirus Vaccines","enrollment":5752},{"nctId":"NCT00231413","phase":"PHASE2","title":"Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-03-04","conditions":"Infections, Papillomavirus","enrollment":383},{"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":"NCT00730847","phase":"PHASE4","title":"A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards.","status":"TERMINATED","sponsor":"GlaxoSmithKline","startDate":"2008-09-17","conditions":"Human Papillomavirus Infection Leading to Cervical Cancer","enrollment":743},{"nctId":"NCT00128661","phase":"PHASE3","title":"Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2004-06-30","conditions":"Cervical Cancer, Precancerous Condition","enrollment":7466},{"nctId":"NCT00309166","phase":"PHASE2","title":"Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-04-05","conditions":"Infections, Papillomavirus","enrollment":270},{"nctId":"NCT00316693","phase":"PHASE2","title":"Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-04-26","conditions":"Infections, Papillomavirus","enrollment":1046},{"nctId":"NCT00492544","phase":"PHASE3","title":"Immunogenicity and Safety of GSK Biologicals' HPV Vaccine 580299 in Healthy Japanese Females 10-15 Years of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-07-02","conditions":"Infections, Papillomavirus","enrollment":100},{"nctId":"NCT00122681","phase":"PHASE3","title":"Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2004-05-06","conditions":"Infections, Papillomavirus","enrollment":18729},{"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":"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":"NCT00345878","phase":"PHASE3","title":"Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-09-25","conditions":"Infections, Papillomavirus","enrollment":271},{"nctId":"NCT00485732","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-06-11","conditions":"Infections, Papillomavirus","enrollment":225},{"nctId":"NCT00344032","phase":"PHASE3","title":"Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-07-28","conditions":"Infections, Papillomavirus","enrollment":354},{"nctId":"NCT00426361","phase":"PHASE3","title":"Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-02-13","conditions":"Infections, Papillomavirus","enrollment":751},{"nctId":"NCT00337818","phase":"PHASE3","title":"Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-06","conditions":"Papillomavirus Type 16/18 Infection, Cervical Intraepithelial Neoplasia","enrollment":770},{"nctId":"NCT00196924","phase":"PHASE3","title":"Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-16/18.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2004-06","conditions":"Infections, Papillomavirus","enrollment":2067},{"nctId":"NCT00306241","phase":"PHASE3","title":"A Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-03","conditions":"Infections, Papillomavirus","enrollment":300},{"nctId":"NCT00290277","phase":"PHASE3","title":"Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV Vaccine in Female Subjects Aged 10-14 Years","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-11","conditions":"Infections, Papillomavirus","enrollment":300},{"nctId":"NCT00169494","phase":"PHASE3","title":"Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2004-09","conditions":"Infections, Papillomavirus","enrollment":770},{"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":"NCT00572000","phase":"NA","title":"Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Healthy Vietnamese Women According to a 0, 1, 6 Month Schedule","status":"UNKNOWN","sponsor":"National Institute for Control of Vaccine and Biologicals","startDate":"2007-11","conditions":"Human Papillomavirus (HPV) Vaccine","enrollment":222}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":61,"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":"HPV-16/18 L1/AS04","genericName":"HPV-16/18 L1/AS04","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","firstApprovalDate":"","aiSummary":"This vaccine stimulates the immune system to produce antibodies and cellular immunity against HPV-16 and HPV-18 L1 capsid proteins, preventing infection and cervical cancer development. Used for Prevention of cervical cancer caused by HPV-16 and HPV-18, Prevention of cervical intraepithelial neoplasia (CIN) grades 2 and 3.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}