{"id":"dtap-hb-prp-t-vaccine-opv","safety":{"commonSideEffects":[{"rate":"10-50","effect":"Injection site reactions (pain, redness, swelling)"},{"rate":"10-30","effect":"Fever"},{"rate":"10-40","effect":"Irritability or fussiness"},{"rate":"5-20","effect":"Drowsiness"},{"rate":"5-15","effect":"Loss of appetite"}]},"_chembl":{"chemblId":"CHEMBL2108573","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"DTaP-HB-PRP~T is a hexavalent vaccine containing inactivated toxoids (diphtheria, tetanus), acellular pertussis antigens, hepatitis B surface antigen, Haemophilus influenzae type b conjugate, combined with oral polio vaccine (OPV) containing live attenuated poliovirus strains. The vaccine triggers both humoral and cell-mediated immune responses to provide protection against these six infectious diseases.","oneSentence":"This combination vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and poliovirus.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:46:04.094Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunization against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and poliomyelitis in infants and children"}]},"trialDetails":[{"nctId":"NCT05794230","phase":"PHASE3","title":"Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2023-03-27","conditions":"Meningococcal Immunisation, Healthy Volunteers","enrollment":1528},{"nctId":"NCT00514709","phase":"PHASE3","title":"Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2007-09","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":1843},{"nctId":"NCT00362336","phase":"PHASE3","title":"Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-08","conditions":"Hepatitis B, Polio, Diphtheria","enrollment":622},{"nctId":"NCT00313911","phase":"PHASE3","title":"Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-07","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":2133},{"nctId":"NCT00343889","phase":"PHASE3","title":"Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-08","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":379},{"nctId":"NCT00534833","phase":"PHASE3","title":"Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2007-09","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":362},{"nctId":"NCT00348881","phase":"PHASE3","title":"Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-06","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":2133}],"_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":[],"phase":"phase_3","status":"active","brandName":"DTaP-HB-PRP~T vaccine + OPV","genericName":"DTaP-HB-PRP~T vaccine + OPV","companyName":"Sanofi Pasteur, a Sanofi Company","companyId":"sanofi","modality":"Biologic","firstApprovalDate":"","aiSummary":"This combination vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and poliovirus. Used for Primary immunization against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and poliomyelitis 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}}