Calendario›SNY›DTaP-IPV-Hep B-PRP~T combined…
DTaP-IPV-Hep B-PRP~T combined…
DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants
Ensayo de Sanofi en Diphtheria · Tetanus · Pertussis · Haemophilus Influenzae Type b Infection · Poliomyelitis · Hepatitis B (del registro, en inglés).
Más ensayos de: Poliomielitis · Hepatitis B.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 310
- Centros
- 16
- Fin del objetivo primario
- abr 2016
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en mar 2014.
Qué mide
Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 International Units (IU)/mL (1 month post third vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP\~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's DTaP-IPV//PRP\~T combined vaccine (Pentaxim™) given at 2, 4, and 6 months of age and Hep B vaccine (Euvax B®) given at 1 and 6 months of age in South Korean infants that received a birth dose of Hep B and born to mothers documented to be serum anti-HBs Ag negative. Primary Objective * To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus, poliovirus types 1, 2, and 3, PRP-T, Hep B) and vaccine response for pertussis antigens (pertussis toxoid \[PT\] and filamentous haemagglutinin \[FHA\]) of Group A versus Group B, one month after the third dose of combined vaccines. Secondary Objectives: * To further study the immunogenicity of the two vaccination schemes, before the first dose and one month after the last dose of vaccines. * To study the safety after each and any dose of vaccines administered in the two vaccination schemes
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02094833), actualizada en abr 2017.