{"id":"v503-vaccine","safety":{"commonSideEffects":[{"rate":"null","effect":"Injection site pain"},{"rate":"null","effect":"Fatigue"},{"rate":"null","effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"This vaccine is a non-replicating virus-like particle (VLP) vaccine that contains the L1 protein of HPV types 16 and 18. Upon administration, the L1 protein is taken up by antigen-presenting cells, which then present the protein to T-cells, stimulating an immune response against the HPV types 16 and 18.","oneSentence":"V503 Vaccine works by stimulating the body's immune system to produce antibodies against the human papillomavirus (HPV) types 16 and 18.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:54:01.021Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16 and 18 in females aged 9 to 26 years"}]},"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":"NCT05119855","phase":"PHASE3","title":"Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2022-03-28","conditions":"Papillomavirus Infections, Coronavirus Disease (COVID-19)","enrollment":165},{"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":"NCT06623409","phase":"PHASE1","title":"Safety and Immunogenicity of V540B in Healthy Adults (V540B-002).","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2024-11-12","conditions":"Healthy","enrollment":72},{"nctId":"NCT04772534","phase":"PHASE3","title":"Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2021-05-17","conditions":"Papillomavirus Infections","enrollment":314},{"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":"NCT03903562","phase":"PHASE3","title":"Immunobridging Study of 9- Valent Human Papillomavirus (9vHPV) Vaccine (V503) in Chinese Females 9 to 45 Years of Age (V503-024)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2019-04-27","conditions":"Papillomavirus Infections","enrollment":1990},{"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":"NCT02653118","phase":"","title":"Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2016-01-22","conditions":"Cervical Cancer, Vulvar Cancer, Vaginal Cancer","enrollment":4453},{"nctId":"NCT05314023","phase":"PHASE3","title":"Immunogenicity and Safety of V503 in Chinese Males 9 Through 19 Years Old (V503-053)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2022-05-07","conditions":"Genital Warts","enrollment":1590},{"nctId":"NCT03998254","phase":"PHASE3","title":"Efficacy, Immunogenicity and Safety of V503 in Chinese Women Aged 20-45 Years (V503-023)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2019-06-26","conditions":"Papillomavirus Infections","enrollment":6000},{"nctId":"NCT00943722","phase":"PHASE3","title":"A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2009-08-27","conditions":"Cervical Cancers, Vulvar Cancer, Vaginal Cancer","enrollment":3074},{"nctId":"NCT05450705","phase":"PHASE3","title":"V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2022-07-22","conditions":"Papillomavirus Infections","enrollment":1500},{"nctId":"NCT03546842","phase":"PHASE3","title":"Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2018-06-29","conditions":"Papillomavirus Infections, Uterine Cervical Neoplasms, Vulvar Neoplasms","enrollment":201},{"nctId":"NCT03158220","phase":"PHASE3","title":"Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2017-09-20","conditions":"Cervical Cancer, Vulvar Cancer, Vaginal Cancer","enrollment":1212},{"nctId":"NCT01304498","phase":"PHASE3","title":"Immunogenicity and Tolerability of V503 Versus GARDASIL (V503-009)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-02-23","conditions":"Human Papillomavirus","enrollment":600},{"nctId":"NCT00988884","phase":"PHASE3","title":"A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2009-10-21","conditions":"Human Papillomavirus Infection","enrollment":1241},{"nctId":"NCT01254643","phase":"PHASE3","title":"A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-01-12","conditions":"Papillomavirus Infections","enrollment":100},{"nctId":"NCT01651949","phase":"PHASE3","title":"Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2012-10-29","conditions":"Genital Warts, Anal Cancer, Anal Intraepithelial Neoplasia","enrollment":2520},{"nctId":"NCT01073293","phase":"PHASE3","title":"A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2010-04-22","conditions":"Papillomavirus Infections","enrollment":1054},{"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},{"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":"NCT02114385","phase":"PHASE3","title":"A Study to Compare Immune Response of V503 to Gardasil in 16- to 26-year-old Men (V503-020)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-03-24","conditions":"Papilloma Viral Infection","enrollment":500},{"nctId":"NCT01984697","phase":"PHASE3","title":"A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2013-12-12","conditions":"Human Papillomavirus Infection","enrollment":1518}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":14,"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":"V503 Vaccine","genericName":"V503 Vaccine","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Biologic","firstApprovalDate":"","aiSummary":"The V503 vaccine is a multivalent human papillomavirus (HPV) L1 virus-like particle (VLP) vaccine used to prevent cervical cancers, vulvar cancer, vaginal cancer, genital lesions, and PAP test abnormalities. It induces an immune response through its biological vaccine mechanism as a component of a vaccine.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}