{"id":"engerix-btm","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Injection site soreness or swelling"},{"rate":"10-15","effect":"Fatigue"},{"rate":"5-10","effect":"Headache"},{"rate":"1-5","effect":"Fever"},{"rate":"5-10","effect":"Myalgia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains recombinant hepatitis B surface antigen produced in yeast cells. When administered, it triggers both humoral and cellular immune responses, leading to the production of anti-HBs antibodies and memory B cells. This immune response provides long-term protection against hepatitis B infection and its complications.","oneSentence":"Engerix-B is a recombinant hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen (HBsAg), providing protection against hepatitis B virus infection.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:46:14.376Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of hepatitis B infection in infants, children, and adults"},{"name":"Post-exposure prophylaxis for hepatitis B"}]},"trialDetails":[{"nctId":"NCT01277042","phase":"PHASE3","title":"Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-02-17","conditions":"Infections, Papillomavirus","enrollment":1212}],"_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":"Engerix-BTM","genericName":"Engerix-BTM","companyName":"GlaxoSmithKline","companyId":"glaxosmithkline","modality":"Biologic","firstApprovalDate":"","aiSummary":"Engerix-B is a recombinant hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen (HBsAg), providing protection against hepatitis B virus infection. Used for Prevention of hepatitis B infection in infants, children, and adults, Post-exposure prophylaxis for hepatitis B.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}