{"id":"hepatitis-a-vaccine-avaxim-80u","safety":{"commonSideEffects":[{"rate":"20-40","effect":"Injection site pain or soreness"},{"rate":"5-15","effect":"Headache"},{"rate":"5-10","effect":"Fatigue"},{"rate":"5-10","effect":"Myalgia"},{"rate":"1-5","effect":"Low-grade fever"}]},"_chembl":{"chemblId":"CHEMBL2109163","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains inactivated (killed) hepatitis A virus antigen that triggers both humoral and cellular immune responses, leading to the production of protective antibodies (anti-HAV IgG) and immunological memory. This prevents infection and disease upon exposure to wild-type hepatitis A virus. The 80U designation refers to the antigen content (80 units) per dose.","oneSentence":"AVAXIM 80U is an inactivated hepatitis A vaccine that stimulates the immune system to produce antibodies against hepatitis A virus.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:15:01.549Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of hepatitis A infection in susceptible individuals"},{"name":"Post-exposure prophylaxis for hepatitis A"}]},"trialDetails":[{"nctId":"NCT02011763","phase":"PHASE4","title":"Safety of Two Doses of Avaxim® 80U Pediatric (Inactivated Hepatitis A Vaccine) in Toddlers, Children and Adolescents","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2013-12","conditions":"Hepatitis A, Hepatitis A Virus","enrollment":355},{"nctId":"NCT00735644","phase":"PHASE3","title":"Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2008-08","conditions":"Japanese Encephalitis, Hepatitis A","enrollment":1200},{"nctId":"NCT00313950","phase":"PHASE4","title":"Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-09","conditions":"Measles, Mumps, Rubella","enrollment":470},{"nctId":"NCT00483470","phase":"PHASE3","title":"Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2007-06","conditions":"Hepatitis A","enrollment":720},{"nctId":"NCT01064141","phase":"PHASE2","title":"A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines","status":"COMPLETED","sponsor":"Sanofi","startDate":"2010-01","conditions":"Dengue Fever, Dengue Hemorrhagic Fever","enrollment":210}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":9,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["AVAXIM 80U Pediatric vaccine"],"phase":"phase_3","status":"active","brandName":"Hepatitis A vaccine AVAXIM 80U","genericName":"Hepatitis A vaccine AVAXIM 80U","companyName":"Sanofi Pasteur, a Sanofi Company","companyId":"sanofi","modality":"Biologic","firstApprovalDate":"","aiSummary":"AVAXIM 80U is an inactivated hepatitis A vaccine that stimulates the immune system to produce antibodies against hepatitis A virus. Used for Prevention of hepatitis A infection in susceptible individuals, Post-exposure prophylaxis for hepatitis A.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}