{"id":"comparator-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":"Myalgia"},{"rate":"1-5","effect":"Low-grade fever"}]},"_chembl":{"chemblId":"CHEMBL3983509","moleculeType":"Small molecule","molecularWeight":"434.92"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ENGERIX-B 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 provides immunity against hepatitis B virus infection.","oneSentence":"ENGERIX-B is a hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen (HBsAg).","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:07:02.909Z","_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":"NCT02942277","phase":"PHASE1","title":"Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2016-10-21","conditions":"Malaria","enrollment":301},{"nctId":"NCT03627507","phase":"PHASE2, PHASE3","title":"Non Inferiority Trial of Locally Manufactured 'Hepa-B' Vaccine in Bangladesh.","status":"COMPLETED","sponsor":"International Centre for Diarrhoeal Disease Research, Bangladesh","startDate":"2018-07-29","conditions":"Hepatitis B Infection","enrollment":158},{"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},{"nctId":"NCT01349283","phase":"PHASE3","title":"Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns","status":"COMPLETED","sponsor":"Crucell Holland BV","startDate":"2011-05","conditions":"Hepatitis B","enrollment":1738}],"_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":"Comparator: Comparator: ENGERIX-B","genericName":"Comparator: Comparator: ENGERIX-B","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Biologic","firstApprovalDate":"","aiSummary":"ENGERIX-B is a small molecule hepatitis B vaccine used as a comparator in clinical trials for conditions such as Hepatitis B Virus Infection and Hepatitis B. It is also used as a comparator in a study for patients with renal predialysis and dialysis, comparing it to a modified process hepatitis B vaccine.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}