{"id":"h5n1-vaccine-arepanrix-gsk","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Injection site pain or swelling"},{"rate":"10-20","effect":"Myalgia (muscle pain)"},{"rate":"10-15","effect":"Headache"},{"rate":"10-15","effect":"Fatigue"},{"rate":"5-10","effect":"Fever"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains inactivated H5N1 virus particles combined with an AS04 adjuvant system (aluminum hydroxide and MPL) to enhance immune response. It works by presenting viral antigens to the immune system, triggering both humoral (antibody) and cell-mediated immune responses that provide protection against H5N1 infection. The adjuvant amplifies the body's natural defense mechanisms to generate robust and durable immunity.","oneSentence":"Arepanrix is an inactivated H5N1 influenza vaccine that stimulates the immune system to produce antibodies and cellular immunity against the H5N1 avian influenza virus.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:47:46.563Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of H5N1 avian influenza infection in at-risk populations"}]},"trialDetails":[{"nctId":"NCT07275060","phase":"PHASE4","title":"Immunogenicity and Safety of 2 Doses of Avian Influenza A (H5N1) Vaccine Administered 3 vs. 8 Weeks Apart","status":"ACTIVE_NOT_RECRUITING","sponsor":"Canadian Immunization Research Network","startDate":"2025-10-14","conditions":"H5N1 Influenza, H5N1 Virus, Avian Influenza","enrollment":312},{"nctId":"NCT07240558","phase":"PHASE3","title":"Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)","status":"RECRUITING","sponsor":"University Health Network, Toronto","startDate":"2025-11-03","conditions":"Influenza (Pandemic), Avian Influenza, Vaccination","enrollment":120}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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":"H5N1 vaccine (Arepanrix, GSK)","genericName":"H5N1 vaccine (Arepanrix, GSK)","companyName":"University Health Network, Toronto","companyId":"university-health-network-toronto","modality":"Biologic","firstApprovalDate":"","aiSummary":"Arepanrix is an inactivated H5N1 influenza vaccine that stimulates the immune system to produce antibodies and cellular immunity against the H5N1 avian influenza virus. Used for Prevention of H5N1 avian influenza infection in at-risk populations.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}