drugset / Trial / NCT01086969

A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India

NCT01086969

Phase 3 Completed 300 enrolled Sanofi
Non-randomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to assess the safety and immunogenicity of a single dose of Menactra® vaccine to support registration. Primary Objectives: * To describe the antibody titers measured by serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination. * To describe the safety profile of participants after one dose of Menactra®.

Timeline

Start
2010-06
Primary completion
2011-02
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Menactra Vaccine 0.5 ml Intramuscular