{"id":"comparator-gardasil","safety":{"commonSideEffects":[{"rate":"80","effect":"Injection site pain"},{"rate":"25","effect":"Injection site swelling"},{"rate":"25","effect":"Injection site erythema"},{"rate":"10","effect":"Fever"},{"rate":"15","effect":"Headache"},{"rate":"5","effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains virus-like particles (VLPs) derived from the major capsid protein of four HPV types. These VLPs are non-infectious and trigger a humoral immune response, generating neutralizing antibodies that prevent infection by these HPV strains. This prevents the development of HPV-related cancers and genital warts caused by these viral types.","oneSentence":"Gardasil is a recombinant quadrivalent human papillomavirus (HPV) vaccine that stimulates the immune system to produce antibodies against HPV types 6, 11, 16, and 18.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:07:01.118Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of cervical cancer caused by HPV types 16 and 18"},{"name":"Prevention of genital warts caused by HPV types 6 and 11"},{"name":"Prevention of anal, vulvar, and vaginal cancers caused by HPV types 16 and 18"}]},"trialDetails":[{"nctId":"NCT06688058","phase":"PHASE1","title":"A Trial to Evaluate Tolerability and Immunogenicity of V540D in Healthy Adults (V540D-004)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2024-12-20","conditions":"Healthy","enrollment":72},{"nctId":"NCT07224477","phase":"PHASE2","title":"A 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Cancer","enrollment":1025},{"nctId":"NCT05372016","phase":"PHASE3","title":"Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females","status":"COMPLETED","sponsor":"Shanghai Bovax Biotechnology Co., Ltd.","startDate":"2020-09-19","conditions":"HPV Infections, Cervical Cancer, Vulvar Cancer","enrollment":1200},{"nctId":"NCT00834106","phase":"PHASE3","title":"Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2008-12-31","conditions":"HPV Infections","enrollment":3006},{"nctId":"NCT00543543","phase":"PHASE3","title":"Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2007-09-24","conditions":"Cervical Cancer, Vulvar Cancer, Vaginal Cancer","enrollment":14840},{"nctId":"NCT00090285","phase":"PHASE3","title":"An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2004-09-03","conditions":"Condylomata Acuminata","enrollment":4065},{"nctId":"NCT00092547","phase":"PHASE3","title":"A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2003-10-08","conditions":"Human, Papillomavirus Infections","enrollment":1781},{"nctId":"NCT00090220","phase":"PHASE3","title":"A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2004-06-16","conditions":"Healthy Adult Female Participants, Prevention, Papillomavirus Infection","enrollment":3819},{"nctId":"NCT00411749","phase":"PHASE2","title":"V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-12-11","conditions":"HPV Infections","enrollment":107},{"nctId":"NCT00496626","phase":"PHASE3","title":"An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2008-07-20","conditions":"Papillomavirus Infections","enrollment":600},{"nctId":"NCT00378560","phase":"PHASE2","title":"V501 Efficacy Study in Women Aged 18 to 26 (V501-027)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-06-12","conditions":"HPV Infections","enrollment":1021},{"nctId":"NCT00517309","phase":"PHASE3","title":"Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2001-12-28","conditions":"Cervical Cancer, Genital Warts","enrollment":1877},{"nctId":"NCT00337428","phase":"PHASE3","title":"Concomitant Use of 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Tetanus","enrollment":1042}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":198,"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":"Comparator: Gardasil","genericName":"Comparator: Gardasil","companyName":"Merck Sharp & Dohme LLC","companyId":"merck-sharp-dohme-llc","modality":"Biologic","firstApprovalDate":"","aiSummary":"Gardasil is a recombinant quadrivalent human papillomavirus (HPV) vaccine that stimulates the immune system to produce antibodies against HPV types 6, 11, 16, and 18. Used for Prevention of cervical cancer caused by HPV types 16 and 18, Prevention of genital warts caused by HPV types 6 and 11, Prevention of anal, vulvar, and vaginal cancers 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}}