{"id":"comparator-engerix-b","safety":{"commonSideEffects":[{"rate":"25-30","effect":"Injection site soreness or swelling"},{"rate":"10-15","effect":"Fatigue"},{"rate":"10-15","effect":"Headache"},{"rate":"5-10","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 protective antibodies (anti-HBs) and memory B cells. This immunological memory provides long-term protection against hepatitis B infection.","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":"2026-03-28T01:06:43.132Z","_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":"NCT03408730","phase":"PHASE3","title":"Lot-to-lot Consistency of Sci-B-Vac™ in Adults","status":"COMPLETED","sponsor":"VBI Vaccines Inc.","startDate":"2017-12-14","conditions":"Hepatitis B Vaccines","enrollment":2838},{"nctId":"NCT00684671","phase":"PHASE4","title":"Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-05-26","conditions":"Hepatitis A, Hepatitis B","enrollment":506},{"nctId":"NCT00440297","phase":"PHASE3","title":"Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-12","conditions":"Hepatitis B Virus Infection","enrollment":277},{"nctId":"NCT00440531","phase":"PHASE3","title":"Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-11","conditions":"Hepatitis B","enrollment":540},{"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}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":205,"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":"Comparator: ENGERIX-B™","genericName":"Comparator: ENGERIX-B™","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Biologic","firstApprovalDate":"","aiSummary":"ENGERIX-B is a hepatitis B vaccine used as a comparator in clinical trials, specifically for Hepatitis B Vaccines, Hepatitis B, Hepatitis A, and Hepatitis B Virus Infection studies. It is compared to other hepatitis B vaccines, including RECOMBIVAX HB and a modified process hepatitis B vaccine, in clinical trials such as NCT03408730.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}