{"id":"dpt-ipv-hib-combined-vaccine","safety":{"commonSideEffects":[{"rate":"10-50%","effect":"Injection site pain, redness, or swelling"},{"rate":"5-15%","effect":"Fever"},{"rate":"5-10%","effect":"Irritability or fussiness"},{"rate":"5-10%","effect":"Drowsiness"},{"rate":"5-10%","effect":"Loss of appetite"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"DPT-IPV-Hib is a pentavalent inactivated vaccine that contains antigens from five pathogens. It works by presenting these antigens to the immune system, triggering both humoral (antibody-mediated) and cell-mediated immune responses that provide protection against these infectious diseases. The vaccine reduces the risk of infection by enabling the body to recognize and rapidly eliminate these pathogens upon exposure.","oneSentence":"This combined vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, pertussis, tetanus, poliomyelitis, and Haemophilus influenzae type b.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:10:00.116Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunization against diphtheria, pertussis, tetanus, poliomyelitis, and Haemophilus influenzae type b in infants and children"}]},"trialDetails":[{"nctId":"NCT02992925","phase":"PHASE3","title":"Phase 3 Study of BK1310 in Healthy Infants","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2016-11","conditions":"Immunization; Infection","enrollment":370},{"nctId":"NCT03891758","phase":"PHASE3","title":"Confirmatory Study of BK1310 in Healthy Infants","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2019-04-01","conditions":"Tetanus, Diphtheria, Pertussis","enrollment":267},{"nctId":"NCT03188692","phase":"PHASE3","title":"Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2017-06-23","conditions":"Immunization","enrollment":33}],"_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":["BK1310"],"phase":"phase_3","status":"active","brandName":"DPT-IPV-Hib (Combined Vaccine)","genericName":"DPT-IPV-Hib (Combined Vaccine)","companyName":"Tanabe Pharma Corporation","companyId":"tanabe-pharma-corporation","modality":"Biologic","firstApprovalDate":"","aiSummary":"This combined vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, pertussis, tetanus, poliomyelitis, and Haemophilus influenzae type b. Used for Primary immunization against diphtheria, pertussis, tetanus, poliomyelitis, and Haemophilus influenzae type b in infants and children.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}