{"id":"placebo-to-v503","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_fixedAt":"2026-03-30T12:50:32.383935","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"V503 is an investigational HPV therapeutic vaccine that aims to generate cellular and humoral immune responses targeting HPV antigens. Unlike prophylactic HPV vaccines, V503 is intended for therapeutic use in patients with existing HPV-related disease, potentially helping the immune system recognize and eliminate HPV-infected cells.","oneSentence":"V503 is a therapeutic vaccine candidate designed to stimulate immune responses against human papillomavirus (HPV) types associated with cervical and other cancers.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:29:02.772Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HPV-related cervical intraepithelial neoplasia (CIN)"},{"name":"HPV-related cancers"}]},"_fixedFields":["pubmed(1)"],"trialDetails":[{"nctId":"NCT04635423","phase":"PHASE3","title":"Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2020-11-30","conditions":"Warts, Genital, Neoplasms, Anal","enrollment":1059},{"nctId":"NCT04199689","phase":"PHASE3","title":"Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2020-02-27","conditions":"Papillomavirus Infections","enrollment":6033},{"nctId":"NCT05285826","phase":"PHASE3","title":"Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2022-02-18","conditions":"Papillomavirus Infections","enrollment":8100},{"nctId":"NCT01047345","phase":"PHASE3","title":"A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2010-02-24","conditions":"Cervical Cancers, Vulvar Cancers, Vaginal Cancers","enrollment":924}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"recentPublications":[{"date":"2015 Nov 27","pmid":"26411885","title":"Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine.","journal":"Vaccine"}],"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":"Placebo to V503","genericName":"Placebo to V503","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Biologic","firstApprovalDate":"","aiSummary":"V503 is a therapeutic vaccine candidate designed to stimulate immune responses against human papillomavirus (HPV) types associated with cervical and other cancers. Used for HPV-related cervical intraepithelial neoplasia (CIN), HPV-related cancers.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}