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Hybrid 5 component DTaP

Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®

Ensayo de Sanofi en Diphtheria · Pertussis · Polio · Hepatitis B · Tetanus (del registro, en inglés).

Más ensayos de: Hepatitis B.

Fase

Fase 2

Estado

Completado

Participantes

460

previstos

Centros

8

Fin del objetivo primario

feb 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en ago 2006.

Qué mide

To provide information concerning the immune response of subjects that received PR5I concomitantly with Prevnar (del registro, en inglés) (14 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H. influenzae type b, hepatitis B virus, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2, and 3. Primary Objective: To evaluate immunogenicity of PR5I with the adjuvant composition enhancement to the hepatitis B component when administered concomitantly with Prevnar® Secondary Objectives: To assess the safety and immunogenicity of PR5I when administered concomitantly, or one month apart with Prevnar® or separately with licensed vaccines used for routine infant vaccination in Canada.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00362427), actualizada en ene 2014.