drugset / Trial / NCT01239043

Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination

NCT01239043

Phase 2 Completed 139 enrolled Sanofi
Non-randomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this trial is to describe antibody persistence and response to re-vaccination with either Menactra® or Menomune® vaccine approximately three years following initial vaccination in adults who participated in trial MTA29 (NCT00874549). Objectives: * To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination. * To evaluate persistence of serum bactericidal antibodies in subjects who received Menactra® or Menomune® vaccine approximately three years ago. * To evaluate the immune response to serogroups A, C, Y, and W-135 in subjects re-vaccinated with either Menactra® or Menomune® vaccine.

Timeline

Start
2010-11
Primary completion
2011-04
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Menactra Vaccine 0.5 ml Intramuscular
Subject Menomune® Vaccine 0.5 ml Subcutaneous