drugset / Trial / NCT00874549

Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years

NCT00874549

Phase 1/2 Completed 216 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupOpen-labelPrevention

Summary

Safety: To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination with either Menactra® vaccine or Menomune® vaccine. Immunogenicity: To evaluate the immune response to serogroups A, C, Y, and W-135 in each of the four study groups.

Timeline

Start
2007-10
Primary completion
2008-01
Completion
2008-10

Drugs

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