drugset / Trial / NCT00391391

Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children

NCT00391391

Phase 2 Completed 520 enrolled Sanofi
RandomizedParallel-groupOpen-labelPrevention

Summary

Primary Objective: To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. Secondary Objectives: * To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. * To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Timeline

Start
2006-10
Primary completion
2007-03
Completion
2007-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Influenza Virus Vaccine Vaccine Intramuscular
Comparator Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) Vaccine Intramuscular

Indications