{"id":"dtwp-hepb-hib-ipv-vaccine","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions (pain, redness, swelling)"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Irritability"},{"rate":null,"effect":"Drowsiness"}]},"_chembl":{"chemblId":"CHEMBL2108573","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"DTwP-HepB-Hib-IPV is a combination vaccine containing inactivated toxoids (diphtheria and tetanus), whole-cell pertussis bacteria, hepatitis B surface antigen, Haemophilus influenzae type b conjugate, and inactivated poliovirus antigens. 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 primary immunization in infants and young children.","oneSentence":"This pentavalent vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and poliomyelitis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:46:05.514Z","_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":"NCT04429295","phase":"PHASE3","title":"Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2020-06-28","conditions":"Pertussis Immunisation, Diphtheria Immunisation, Polio Immunisation","enrollment":460},{"nctId":"NCT06947499","phase":"PHASE2, PHASE3","title":"A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series","status":"RECRUITING","sponsor":"LG Chem","startDate":"2025-05-30","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":1186},{"nctId":"NCT06413121","phase":"PHASE3","title":"Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV","status":"RECRUITING","sponsor":"Serum Institute of India Pvt. Ltd.","startDate":"2024-05-06","conditions":"Diptheria Immunization, Tetanus Immunization, Pertussis Immunization","enrollment":1557},{"nctId":"NCT05457946","phase":"PHASE2, PHASE3","title":"Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series","status":"UNKNOWN","sponsor":"LG Chem","startDate":"2023-04-01","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":1438},{"nctId":"NCT04073459","phase":"PHASE2","title":"Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants","status":"UNKNOWN","sponsor":"LG Chem","startDate":"2019-11","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":336}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["EasySix™"],"phase":"phase_3","status":"active","brandName":"DTwP-HepB-Hib-IPV vaccine","genericName":"DTwP-HepB-Hib-IPV vaccine","companyName":"Sanofi Pasteur, a Sanofi Company","companyId":"sanofi","modality":"Biologic","firstApprovalDate":"","aiSummary":"This pentavalent vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and poliomyelitis. Used for Primary immunization against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and poliomyelitis in infants and children.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}