{"id":"dtp-hb-hib-vaccine","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":"CHEMBL2108573","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"DTP-HB-Hib is a pentavalent inactivated vaccine containing antigens from five pathogens. The diphtheria and tetanus components are toxoids (inactivated bacterial toxins), the pertussis component contains acellular pertussis antigens, the hepatitis B component is recombinant HBsAg, and the Hib component is a polysaccharide conjugate. Together, these antigens trigger both humoral (antibody) and cell-mediated immune responses to provide protection against these five infectious diseases.","oneSentence":"This combination vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b pathogens.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:31:52.620Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of diphtheria"},{"name":"Prevention of tetanus"},{"name":"Prevention of pertussis (whooping cough)"},{"name":"Prevention of hepatitis B"},{"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and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)","status":"WITHDRAWN","sponsor":"PT Bio Farma","startDate":"2025-12","conditions":"Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction, Pertussis Vaccine Adverse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},{"nctId":"NCT02409095","phase":"PHASE4","title":"Study Comparing DTP-HB-Hib by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In Infants","status":"TERMINATED","sponsor":"Serum Institute of India Pvt. Ltd.","startDate":"2015-01","conditions":"Immune Response to DTP-HB-Hib Vaccine","enrollment":211},{"nctId":"NCT03310073","phase":"PHASE4","title":"Immunogenicity and Safety Profile of Primary Dose of bOPV Bio Farma Given Simultaneously With Pentabio And IPV","status":"COMPLETED","sponsor":"PT Bio Farma","startDate":"2016-07","conditions":"Healthy","enrollment":143},{"nctId":"NCT02095314","phase":"PHASE2, PHASE3","title":"Antibody Persistence, Immune Response and Safety After Doses of Pentabio Vaccine","status":"COMPLETED","sponsor":"PT Bio Farma","startDate":"2014-03","conditions":"Healthy","enrollment":399},{"nctId":"NCT01986335","phase":"PHASE3","title":"Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial","status":"COMPLETED","sponsor":"PT Bio Farma","startDate":"2012-08","conditions":"Healthy","enrollment":600},{"nctId":"NCT01986322","phase":"PHASE2","title":"Immunogenicity and Safety of DTP/HB/Hib (Bio Farma)Compared to DTP/HB Given Simultaneously With Hib(Registered)Vaccine","status":"COMPLETED","sponsor":"PT Bio Farma","startDate":"2011-07","conditions":"Healthy","enrollment":220},{"nctId":"NCT01977196","phase":"PHASE1","title":"The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)","status":"COMPLETED","sponsor":"PT Bio Farma","startDate":"2011-04","conditions":"Healthy","enrollment":30}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Pentavac"],"phase":"marketed","status":"active","brandName":"DTP-HB-Hib vaccine","genericName":"DTP-HB-Hib vaccine","companyName":"Serum Institute of India Pvt. Ltd.","companyId":"serum-institute-of-india-pvt-ltd","modality":"Biologic","firstApprovalDate":"","aiSummary":"This combination vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b pathogens. Used for Prevention of diphtheria, Prevention of tetanus, Prevention of pertussis (whooping cough).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}