Calendario›SNY›Meningococcal polysaccharide…

Meningococcal polysaccharide…

Study of a Single Dose of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects

Ensayo de Sanofi en Meningitis · Meningococcal Meningitis · Meningococcal Infections (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

200

previstos

Centros

3

Fin del objetivo primario

sep 2012

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en ene 2012.

Qué mide

Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine (28 Days post-vaccination) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study is designed to assess the safety and immunogenicity of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) to support registration of the product in Japan. Primary Objective: * To describe the seroprotection rate \[% of subjects with serum bactericidal assay using baby rabbit complement (SBA-BR) ≥1:128\] to meningococcal antigens (serogroups A, C, Y and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age Secondary Objectives: * To describe the safety following receipt of SP284 vaccine in subjects 2 through 55 years of age * To describe the immune responses to meningococcal antigens (serogroups A, C, Y and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01519713), actualizada en may 2013.