{"id":"henogen-hb-vaccine","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain or swelling"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL2108573","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains hepatitis B surface antigen (HBsAg) produced via recombinant DNA technology, which triggers both humoral and cell-mediated immune responses. This leads to the production of anti-HBs antibodies and memory B cells that provide long-term protection against hepatitis B infection. The vaccine may also include adjuvants to enhance immunogenicity.","oneSentence":"Henogen HB vaccine stimulates the immune system to produce antibodies and cellular immunity against hepatitis B virus surface antigen.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T00:47:41.129Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of hepatitis B infection in unvaccinated or non-responsive populations"}]},"trialDetails":[{"nctId":"NCT00445185","phase":"PHASE3","title":"Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or Fendrix™","status":"COMPLETED","sponsor":"Henogen","startDate":"2007-03","conditions":"Hepatitis B","enrollment":102},{"nctId":"NCT00291954","phase":"PHASE3","title":"Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination","status":"COMPLETED","sponsor":"Henogen","startDate":"2006-03","conditions":"Hepatitis B","enrollment":257},{"nctId":"NCT00291941","phase":"PHASE3","title":"A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.","status":"COMPLETED","sponsor":"Henogen","startDate":"2006-02","conditions":"Hepatitis B","enrollment":300}],"_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":"Henogen HB vaccine","genericName":"Henogen HB vaccine","companyName":"Henogen","companyId":"henogen","modality":"Biologic","firstApprovalDate":"","aiSummary":"Henogen HB vaccine stimulates the immune system to produce antibodies and cellular immunity against hepatitis B virus surface antigen. Used for Prevention of hepatitis B infection in unvaccinated or non-responsive populations.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}