{"id":"engerixtm-b","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":{"chemblId":"CHEMBL1160385","moleculeType":"Small molecule","molecularWeight":"182.27"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains recombinant hepatitis B surface antigen (HBsAg) produced in yeast cells. When administered, it triggers both humoral and cellular immune responses, leading to the production of protective antibodies (anti-HBs) 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, providing protection against hepatitis B virus infection.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:42:18.316Z","_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":"NCT01777295","phase":"PHASE2","title":"Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-02-25","conditions":"Hepatitis B","enrollment":81},{"nctId":"NCT00289744","phase":"PHASE3","title":"Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2004-02-16","conditions":"Hepatitis B, Hepatitis A","enrollment":178},{"nctId":"NCT00774995","phase":"PHASE4","title":"Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-11","conditions":"Hepatitis B","enrollment":49},{"nctId":"NCT00880477","phase":"PHASE3","title":"Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2001-01","conditions":"Hepatitis B","enrollment":140}],"_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":["Engerix-B"],"phase":"marketed","status":"active","brandName":"EngerixTM-B","genericName":"EngerixTM-B","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, 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}}