{"id":"dtpw-hbv-hib-menac-conjugate-vaccine","safety":{"commonSideEffects":[{"rate":"20-50","effect":"Injection site reactions (pain, redness, swelling)"},{"rate":"10-30","effect":"Fever"},{"rate":"10-20","effect":"Irritability"},{"rate":"5-15","effect":"Drowsiness"},{"rate":"5-10","effect":"Loss of appetite"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains inactivated toxoids (diphtheria, tetanus), acellular pertussis antigens, recombinant hepatitis B surface antigen, and polysaccharide conjugates from Hib and meningococcal serogroups A and C linked to carrier proteins. This conjugate approach enhances immunogenicity by promoting T-cell dependent responses, enabling protection in infants and young children against these six major bacterial pathogens.","oneSentence":"This combination vaccine stimulates immune responses against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and Neisseria meningitidis serogroups A and C through conjugate technology.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:10:15.100Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and Neisseria meningitidis serogroups A and C in infants and children"}]},"trialDetails":[{"nctId":"NCT00317135","phase":"PHASE3","title":"Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2003-12-11","conditions":"Diphtheria, Hepatitis B, Whole Cell Pertussis","enrollment":500},{"nctId":"NCT00317187","phase":"PHASE3","title":"Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2004-06-08","conditions":"Hepatitis B, Diphtheria, Whole Cell Pertussis","enrollment":500},{"nctId":"NCT00317122","phase":"PHASE3","title":"Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at Birth","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2004-10","conditions":"Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis","enrollment":192},{"nctId":"NCT00317161","phase":"PHASE3","title":"Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2004-08","conditions":"Diphtheria, Hepatitis B, Haemophilus Influenzae Type b","enrollment":1000},{"nctId":"NCT00290303","phase":"PHASE3","title":"Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2004-05","conditions":"Haemophilus Influenzae Type b, Diphtheria, Whole Cell Pertussis","enrollment":996},{"nctId":"NCT00317174","phase":"PHASE2","title":"A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2003-07","conditions":"Haemophilus Influenzae Type b, Tetanus, Whole Cell Pertussis","enrollment":450},{"nctId":"NCT00291967","phase":"PHASE2","title":"Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2002-11","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":525}],"_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":[],"phase":"phase_3","status":"active","brandName":"DTPw-HBV/Hib-MenAC conjugate vaccine","genericName":"DTPw-HBV/Hib-MenAC conjugate vaccine","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","firstApprovalDate":"","aiSummary":"This combination vaccine stimulates immune responses against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and Neisseria meningitidis serogroups A and C through conjugate technology. Used for Prevention of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and Neisseria meningitidis serogroups A and C in infants and children.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}