{"id":"dtap-ipv-hib-hepb-vaccine","safety":{"commonSideEffects":[{"rate":"10-50%","effect":"Injection site reactions (pain, redness, swelling)"},{"rate":"10-30%","effect":"Fever"},{"rate":"5-20%","effect":"Irritability"},{"rate":"5-15%","effect":"Drowsiness"},{"rate":"5-10%","effect":"Loss of appetite"}]},"_chembl":{"chemblId":"CHEMBL2108573","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"DTaP-IPV-Hib-HepB is a hexavalent vaccine containing inactivated toxoids (diphtheria and tetanus), inactivated pertussis antigens, inactivated poliovirus, Haemophilus influenzae type b conjugate, and hepatitis B surface antigen. Upon administration, these antigens trigger both humoral and cellular immune responses, leading to the production of protective antibodies and memory cells against all six pathogens.","oneSentence":"This combination vaccine stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and hepatitis B pathogens.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:10:04.516Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and hepatitis B 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":"NCT06647407","phase":"PHASE1, PHASE2","title":"Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2024-11-05","conditions":"Meningococcal Immunization, Healthy Volunteers","enrollment":750},{"nctId":"NCT06618196","phase":"PHASE2","title":"Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscularly in Healthy Infants At 2, 4, 6 Months of Age","status":"NOT_YET_RECRUITING","sponsor":"LG Chem","startDate":"2024-10-02","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":336},{"nctId":"NCT05952596","phase":"PHASE1","title":"A Study to Evaluate Safety and Immunogenicity of APV006 in Healthy Adults","status":"UNKNOWN","sponsor":"LG Chem","startDate":"2023-07-17","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":42},{"nctId":"NCT01896596","phase":"PHASE4","title":"Hepatitis B Vaccination in Infants","status":"COMPLETED","sponsor":"Public Health England","startDate":"2013-07","conditions":"Meningococcal Disease, Pneumococcal Disease, Haemophilus Influenzae Serotype b Disease","enrollment":300},{"nctId":"NCT01480258","phase":"PHASE3","title":"Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)","status":"COMPLETED","sponsor":"MCM Vaccines B.V.","startDate":"2011-11-23","conditions":"Bacterial Infections, Virus Diseases","enrollment":1315},{"nctId":"NCT01839175","phase":"PHASE3","title":"Concomitant Administration of a New Hexavalent Vaccine With a Meningococcal Serogroup C Conjugate Vaccine in Healthy Infants During Primary Series Immunisation Followed by Booster Vaccination","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2013-04","conditions":"Neisseria Meningitidis, Bacterial Infections, Virus Diseases","enrollment":350},{"nctId":"NCT00654901","phase":"PHASE3","title":"Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2008-03","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":881},{"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":"NCT00303316","phase":"PHASE3","title":"Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants","status":"COMPLETED","sponsor":"Sanofi","startDate":"2006-02","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":458}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Hexaxim®"],"phase":"phase_3","status":"active","brandName":"DTaP-IPV-Hib-HepB vaccine","genericName":"DTaP-IPV-Hib-HepB vaccine","companyName":"Sanofi Pasteur, a Sanofi Company","companyId":"sanofi","modality":"Biologic","firstApprovalDate":"","aiSummary":"This combination vaccine stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and hepatitis B pathogens. Used for Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and hepatitis B 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}}