{"id":"tritanrix-hepb-kft","safety":{"commonSideEffects":[{"rate":"10-50","effect":"Injection site reactions (pain, redness, swelling)"},{"rate":"5-15","effect":"Fever"},{"rate":"5-10","effect":"Irritability"},{"rate":"5-10","effect":"Drowsiness"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains diphtheria and tetanus toxoids (inactivated bacterial toxins) that stimulate antibody production against these toxins, acellular pertussis antigens that trigger immune responses to Bordetella pertussis, and recombinant hepatitis B surface antigen (HBsAg) that elicits protective antibodies against hepatitis B virus. Together, these components induce humoral and cellular immune responses that provide protection against all four pathogens.","oneSentence":"Tritanrix-HepB is a combination vaccine that provides immunization against diphtheria, tetanus, pertussis, and hepatitis B through simultaneous administration of inactivated toxoids and recombinant hepatitis B surface antigen.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:54:35.200Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunization against diphtheria, tetanus, pertussis, and hepatitis B in infants and children"}]},"trialDetails":[{"nctId":"NCT00158756","phase":"PHASE3","title":"Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-09-12","conditions":"Hepatitis B","enrollment":308},{"nctId":"NCT00169442","phase":"PHASE3","title":"Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-02-10","conditions":"Whole Cell Pertussis, Diphtheria, Hepatitis B","enrollment":745},{"nctId":"NCT00473668","phase":"PHASE3","title":"Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-06-01","conditions":"Whole Cell Pertussis, Haemophilus Influenzae Type b, Tetanus","enrollment":300},{"nctId":"NCT00332566","phase":"PHASE3","title":"Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-06","conditions":"Hepatitis B, Whole Cell Pertussis, Tetanus","enrollment":148}],"_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":["DTPw-HBV Kft"],"phase":"phase_3","status":"active","brandName":"Tritanrix™-HepB Kft","genericName":"Tritanrix™-HepB Kft","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","firstApprovalDate":"","aiSummary":"Tritanrix-HepB is a combination vaccine that provides immunization against diphtheria, tetanus, pertussis, and hepatitis B through simultaneous administration of inactivated toxoids and recombinant hepatitis B surface antigen. Used for Primary immunization against diphtheria, tetanus, pertussis, and hepatitis B in infants and children.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}