{"id":"recombinant-hepatitis-b-dtp-hb-hib","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":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains recombinant hepatitis B surface antigen along with inactivated toxoids and antigens from diphtheria, tetanus, and pertussis bacteria, plus Haemophilus influenzae type b polysaccharide conjugate. Upon administration, these antigens trigger both humoral and cellular immune responses, leading to the production of specific antibodies and memory cells that protect against infection with these five pathogens.","oneSentence":"This combination vaccine provides immunization against hepatitis B, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b by stimulating the immune system to produce protective antibodies against these pathogens.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:31:29.207Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of hepatitis B infection"},{"name":"Prevention of diphtheria"},{"name":"Prevention of tetanus"},{"name":"Prevention of pertussis (whooping cough)"},{"name":"Prevention of Haemophilus influenzae type b infection"}]},"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and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)","status":"WITHDRAWN","sponsor":"PT Bio Farma","startDate":"2025-12","conditions":"Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction, Pertussis Vaccine Adverse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":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Hep B + DTP-HB-Hib"],"phase":"phase_3","status":"active","brandName":"Recombinant Hepatitis B + DTP-HB-Hib","genericName":"Recombinant Hepatitis B + DTP-HB-Hib","companyName":"PT Bio Farma","companyId":"pt-bio-farma","modality":"Biologic","firstApprovalDate":"","aiSummary":"This combination vaccine provides immunization against hepatitis B, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b by stimulating the immune system to produce protective antibodies against these pathogens. Used for Prevention of hepatitis B infection, Prevention of diphtheria, Prevention of tetanus.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}