drugset / Trial / NCT00831675

Study of Safety and Immunogenicity of Fluzone® in Healthy Children

NCT00831675

Phase 4 Completed 30 enrolled Sanofi Pasteur, a Sanofi Company
Non-randomizedParallel-groupOpen-labelPrevention

Summary

To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months. To describe the immunogenicity of the 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months

Timeline

Start
2004-09
Primary completion
2006-04
Completion
2006-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Influenza Virus Vaccine Vaccine 0.25 ml Intramuscular

Indications