{"id":"hbvaxpro-5-g","safety":{"commonSideEffects":[{"rate":"10-30","effect":"Injection site soreness or swelling"},{"rate":"1-6","effect":"Fever"},{"rate":"1-5","effect":"Fatigue"},{"rate":"1-5","effect":"Headache"},{"rate":"1-3","effect":"Myalgia"}]},"_chembl":{"chemblId":"CHEMBL3693395","moleculeType":"Small molecule","molecularWeight":"530.55"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains hepatitis B surface antigen (HBsAg) produced through recombinant DNA technology in yeast cells. When administered, it triggers both humoral and cellular immune responses, leading to the production of protective antibodies (anti-HBs) against hepatitis B virus infection. This provides active immunization and long-term protection against hepatitis B disease.","oneSentence":"HBVAXPRO is a recombinant hepatitis B surface antigen vaccine that stimulates the immune system to produce antibodies against hepatitis B virus.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:14:52.907Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of hepatitis B infection in infants, children, and adults"}]},"trialDetails":[{"nctId":"NCT03910972","phase":"PHASE1, PHASE2","title":"Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults","status":"COMPLETED","sponsor":"Baylor College of Medicine","startDate":"2019-10-07","conditions":"Schistosomiasis, Schistosoma Mansoni","enrollment":290},{"nctId":"NCT05155579","phase":"PHASE1","title":"Assessment of Safety and Immunogenicity of a Single Vial Presentation of R21/Matrix-M and Co-Administration With EPI Vaccines","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2022-05-14","conditions":"Malaria","enrollment":593},{"nctId":"NCT02445703","phase":"PHASE4","title":"Comparison of Immunization Schedules of Inactivated Hepatitis A Vaccine and Combined Hepatitis A and Hepatitis B Vaccine","status":"COMPLETED","sponsor":"Sinovac Biotech Co., Ltd","startDate":"2014-05","conditions":"Hepatitis A, Hepatitis B","enrollment":301},{"nctId":"NCT02012998","phase":"PHASE3","title":"Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2014-01","conditions":"Virus Diseases, Hepatitis B","enrollment":751},{"nctId":"NCT00393523","phase":"PHASE3","title":"Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-09","conditions":"Hepatitis B","enrollment":1478},{"nctId":"NCT02152709","phase":"PHASE3","title":"Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine","status":"COMPLETED","sponsor":"Jiangsu Province Centers for Disease Control and Prevention","startDate":"2008-11","conditions":"Hepatitis B","enrollment":1537}],"_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":["Hepatitis B vaccine (rDNA)"],"phase":"phase_3","status":"active","brandName":"HBVAXPRO 5µg","genericName":"HBVAXPRO 5µg","companyName":"Sanofi Pasteur, a Sanofi Company","companyId":"sanofi","modality":"Biologic","firstApprovalDate":"","aiSummary":"HBVAXPRO is a recombinant hepatitis B surface antigen vaccine that stimulates the immune system to produce antibodies against hepatitis B virus. Used for Prevention of hepatitis B infection in infants, children, and adults.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}