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Hexavalent vaccine versus Pentaxim plus hepatitis B in South Korean infants
2016-002873-36Phase 3
- Sponsor
- Sanofi
- Start
- Jul 2016
- Modality
- Split/Subunit Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
- Countries
- 1
01
Overview
Phase 3 trial of DTaP-IPV-Hep B-PRP-T vaccine, diphtheria toxoid + tetanus toxoid + acellular pertussis vaccine + inactivated poliovirus vaccine + haemophilus influenzae type b conjugate vaccine and Hepatitis B vaccine in diphtheria, Tetanus, pertussis and 3 more (2 arms), sponsored by Sanofi. Primary endpoint: Non-inferiority of seroprotection and pertussis vaccine response.
02
Drugs
DTaP-IPV-Hep B-PRP-T vaccinediphtheria toxoid + tetanus toxoid + acellular pertussis vaccine + inactivated poliovirus vaccine + haemophilus influenzae type b conjugate vaccineHepatitis B vaccine
03
Conditions
diphtheriaTetanuspertussispoliomyelitisHaemophilus influenzae type b disease (Hib)
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