{"id":"dtap5-hbv-ipv-hib","safety":{"commonSideEffects":[{"rate":"10-50","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":"DTaP5-HBV-IPV-Hib is a hexavalent vaccine containing inactivated toxoids (diphtheria and tetanus), acellular pertussis antigens, hepatitis B surface antigen, inactivated poliovirus, and Haemophilus influenzae type b conjugate. Upon administration, these antigens trigger both humoral (antibody) and cell-mediated immune responses, providing protection against these six infectious diseases. The vaccine is designed for pediatric immunization to prevent serious bacterial and viral infections.","oneSentence":"This combination vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:32:01.949Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Active immunization against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b in infants and children"}]},"trialDetails":[{"nctId":"NCT04535037","phase":"PHASE4","title":"A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)'s Infanrix Hexa Vaccine (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and Toddlers","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2021-05-26","conditions":"Diphtheria","enrollment":500}],"_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":["Vaxelis"],"phase":"marketed","status":"active","brandName":"DTaP5-HBV-IPV-Hib","genericName":"DTaP5-HBV-IPV-Hib","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","firstApprovalDate":"","aiSummary":"This combination vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b. Used for Active immunization against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type 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}}