{"id":"hep-b-pentabio-registered","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain, redness, or swelling"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Irritability or fussiness"},{"rate":null,"effect":"Drowsiness"}]},"_chembl":{"chemblId":"CHEMBL3120703","moleculeType":"Small molecule","molecularWeight":"286.50"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains inactivated or recombinant antigens from hepatitis B virus and other pathogens that trigger B and T cell responses, leading to production of protective antibodies and cellular immunity. This combination formulation allows simultaneous protection against multiple diseases in a single injection, improving vaccination compliance and coverage in pediatric populations.","oneSentence":"Hep B + Pentabio is a combination vaccine that provides immunization against hepatitis B and five other infectious diseases (diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b) by stimulating adaptive immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:15:00.360Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hepatitis B prevention"},{"name":"Diphtheria prevention"},{"name":"Tetanus prevention"},{"name":"Pertussis (whooping cough) prevention"},{"name":"Poliomyelitis prevention"},{"name":"Haemophilus influenzae type b infection prevention"}]},"trialDetails":[{"nctId":"NCT05482282","phase":"PHASE3","title":"Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)","status":"WITHDRAWN","sponsor":"PT Bio Farma","startDate":"2025-12","conditions":"Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction, Pertussis Vaccine Adverse Reaction","enrollment":""},{"nctId":"NCT04071379","phase":"PHASE3","title":"Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B","status":"COMPLETED","sponsor":"PT Bio Farma","startDate":"2020-10-13","conditions":"Immunogenicity, Safety","enrollment":220}],"_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":["Recombinant Hepatitis B (Bio Farma) + Pentabio (Bio Farma)"],"phase":"phase_3","status":"active","brandName":"Hep B + Pentabio (registered)","genericName":"Hep B + Pentabio (registered)","companyName":"PT Bio Farma","companyId":"pt-bio-farma","modality":"Biologic","firstApprovalDate":"","aiSummary":"The Pentabio vaccine, when primed with recombinant Hepatitis B, was compared in a clinical trial (NCT04071379) to the DTP-HB-Hib vaccine from Bio Farma for immunogenicity and safety. The trial, conducted by PT Bio Farma, studied the reactions to the diphtheria, tetanus, and pertussis vaccines in addition to the Hepatitis B vaccine.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}