Calendario›SNY›Meningococcal

Meningococcal

Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine

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

Fase

Fase 2

Estado

Completado

Participantes

834

previstos

Centros

15

Fin del objetivo primario

jun 2012

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en sep 2011.

Qué mide

Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® (Day 28 post-vaccination) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this trial is to describe the safety and antibody response to revaccination with Menactra vaccine in persons who received their first dose at ≥11 years of age. Primary Objective: \- To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured by serum bactericidal assay using human complement (SBA-HC), induced by Menactra vaccine in subjects who were first vaccinated with Menactra 4-6 years ago. Secondary Objective: \- To evaluate the antibody responses to serogroups A, C, Y, and W-135 in serum specimens collected 6 days post-vaccination in a subset of study population. Observational Objective: \- To describe the rates of immediate reactions, solicited injection-site and systemic reactions, unsolicited adverse events and serious adverse events following vaccination.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01442675), actualizada en nov 2014.