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DTaP IPV HB PRP~T vaccine

Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants

Ensayo de Sanofi en Diphtheria · Tetanus · Pertussis · Haemophilus Influenzae Type b · Hepatitis B (del registro, en inglés).

Más ensayos de: Hepatitis B.

Fase

Fase 3

Estado

Completado

Participantes

263

previstos

Centros

1

Fin del objetivo primario

may 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, simple ciego. Comenzó en may 2008.

Qué mide

Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ (Day 150 (1 month after dose 3)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP\~T vaccine has immunological and safety profiles that are comparable to those of the control vaccine that is already marketed (Infanrix®Hexa) Primary Objective: To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP\~T combined vaccine induces an immune response that is at least as good as the response following Infanrix®Hexa in terms of seroprotection rates to HB, one month after a three-dose primary series (2, 4 and 6 months) Secondary Objectives: * To describe in each group the immunogenicity to vaccine components (for DTaP-IPV-Hep B-PRP\~T and Infanrix®Hexa) one month after the third dose of the primary series. * To assess the overall safety in each group one month after each dose of the primary series and through the entire study.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00831753), actualizada en abr 2016.