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DTaP-IPV

DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants

Ensayo de Sanofi en Tetanus · Diphtheria · Pertussis · Poliomyelitis · Bacterial Meningitis (del registro, en inglés).

Más ensayos de: Poliomielitis.

Fase

Fase 3

Estado

Completado

Participantes

424

previstos

Centros

12

Fin del objetivo primario

may 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en oct 2014.

Qué mide

Percentage of participants with anti-Diphtheria level ≥ 0.1 IU/mL post-dose 3 (21 Days post-dose 3) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary objective: * To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP), Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3 antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B: DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary vaccination (all antigens). Secondary objectives: * To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4) in the two study groups (Group A and Group B). * To describe the safety after each dose of each vaccine in the two study groups (Group A and Group B). * To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4 (Group C)

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02274285), actualizada en abr 2022.