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The vaccine components are either inactivated toxins (diphtheria and tetanus toxoids), inactivated bacterial cells (pertussis), inactivated viral particles (hepatitis B surface antigen and poliovirus), enabling safe immunization without causing disease.","oneSentence":"This combination vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, hepatitis B, and polio viruses.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:10:16.519Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis in infants and children"}]},"trialDetails":[{"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":"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":"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":"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":"NCT00446875","phase":"NA","title":"Analgesic Properties of Oral Sucrose During Immunizations","status":"COMPLETED","sponsor":"Milton S. Hershey Medical Center","startDate":"2007-01","conditions":"Procedural Pain","enrollment":98},{"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},{"nctId":"NCT02094833","phase":"PHASE3","title":"DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2014-03","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":310},{"nctId":"NCT00619502","phase":"PHASE3","title":"Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi 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Company","startDate":"2013-10","conditions":"Diphtheria, Tetanus, Whooping Cough","enrollment":558},{"nctId":"NCT01948193","phase":"PHASE3","title":"Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2014-02","conditions":"Diphtheria, Tetanus, Whooping Cough","enrollment":177},{"nctId":"NCT00315055","phase":"PHASE3","title":"Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-07","conditions":"Hepatitis B, Polio, Diphtheria","enrollment":310},{"nctId":"NCT01444781","phase":"PHASE3","title":"Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi 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Used for Prevention of diphtheria, tetanus, pertussis, hepatitis 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}}