{"id":"hexaxim","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":"Hexaxim combines antigens from six pathogens in a single formulation to induce protective immunity. The vaccine contains inactivated poliovirus, diphtheria and tetanus toxoids, acellular pertussis components, hepatitis B surface antigen, and Haemophilus influenzae type b conjugate, allowing simultaneous protection against multiple diseases with a single injection.","oneSentence":"Hexaxim is a hexavalent vaccine that provides immunization against six infectious diseases by stimulating the immune system to produce antibodies against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:15:11.161Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b in infants and children"}]},"trialDetails":[{"nctId":"NCT06736041","phase":"PHASE3","title":"Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2024-12-18","conditions":"Pneumococcal Immunization","enrollment":1714},{"nctId":"NCT06793826","phase":"","title":"Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2025-01-17","conditions":"Hepatitis B, Haemophilus Influenzae Type b Immunisation","enrollment":713},{"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":"NCT02697474","phase":"PHASE3","title":"Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2016-02","conditions":"Hepatitis B","enrollment":150},{"nctId":"NCT02817451","phase":"PHASE3","title":"DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2016-07-14","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":53},{"nctId":"NCT02428491","phase":"PHASE3","title":"Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2015-04-20","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":354},{"nctId":"NCT02610348","phase":"NA","title":"Anti-Hep B Antibodies at Age 12 to 18 Months After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine Concomitantly With Prevnar® at 2, 4 and 6 Months of Age","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2015-11","conditions":"Hepatitis B","enrollment":122}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":16,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Hexyon®","Hexacima®"],"phase":"phase_3","status":"active","brandName":"Hexaxim®","genericName":"Hexaxim®","companyName":"Sanofi Pasteur, a Sanofi Company","companyId":"sanofi-pasteur-a-sanofi-company","modality":"Biologic","firstApprovalDate":"","aiSummary":"Hexaxim is a hexavalent vaccine that provides immunization against six infectious diseases by stimulating the immune system to produce antibodies against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b. Used for Primary immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b in infants and children.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}