NCT00391391

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

Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Healthy Infants and Young Children.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 520 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 6 Months – 8 Years
• Healthy volunteers: Accepted

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.

Conditions

• Orthomyxoviridae Infection
• Influenza
• Myxovirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Split, Inactivated, Trivalent Influenza Vaccine	Vaccine (infant dose)
BIOLOGICAL	Split, Inactivated, Trivalent Influenza Vaccine	Vaccine (children dose)
BIOLOGICAL	Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)	Vaccine (infant dose)
BIOLOGICAL	Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)	Vaccine (children dose)

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-03-01
• Completion: 2007-10-01
• First posted: 2006-10-24
• Last updated: 2011-12-01
• Results posted: 2011-11-22

Locations

19 sites across 1 country: United States