{"id":"engerix-tm","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Injection site soreness or swelling"},{"rate":"10-15","effect":"Fatigue"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Fever (low-grade)"},{"rate":"5-10","effect":"Myalgia"}]},"_chembl":{"chemblId":"CHEMBL3940508","moleculeType":"Small molecule","molecularWeight":"567.84"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains recombinant hepatitis B surface antigen produced in yeast cells, which is adsorbed onto aluminum hydroxide as an adjuvant. Upon administration, it triggers both humoral and cellular immune responses, leading to the production of protective antibodies (anti-HBs) and memory B cells that provide long-term immunity against hepatitis B virus infection.","oneSentence":"Engerix-B is a recombinant hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen (HBsAg).","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:10:53.165Z","_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":"NCT03038802","phase":"PHASE1, PHASE2","title":"A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection","status":"NOT_YET_RECRUITING","sponsor":"Vaxine Pty Ltd","startDate":"2026-03-01","conditions":"Chronic Hepatitis b","enrollment":40},{"nctId":"NCT01311024","phase":"","title":"Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage","status":"COMPLETED","sponsor":"Arto Palmu","startDate":"2011-04","conditions":"Pneumococcal Infections","enrollment":2341},{"nctId":"NCT00839254","phase":"PHASE3","title":"Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-02-18","conditions":"Infections, Streptococcal, Streptococcus Pneumoniae","enrollment":6181},{"nctId":"NCT00861380","phase":"PHASE3","title":"Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-05-04","conditions":"Infections, Streptococcal, Streptococcus Pneumoniae","enrollment":41188},{"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":"NCT00652938","phase":"PHASE3","title":"Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-04-09","conditions":"Infections, Papillomavirus","enrollment":744}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"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 TM","genericName":"Engerix TM","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). 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}}