NCT00258817

Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine

Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2005-2006 Formulation)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 36 Months
• Healthy volunteers: Accepted

Summary

To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains. Observational Objectives: To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, 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 2005-2006 pediatric formulation of Fluzone vaccine, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Virus Vaccine (Fluzone®)	0.25 mL, Intramuscular (Day 0 and Day 28)
BIOLOGICAL	Influenza Virus Vaccine (Fluzone®)	0.25 mL, Intramuscular (Day 0)

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-03-01
• Completion: 2007-08-01
• First posted: 2005-11-28
• Last updated: 2016-04-14
• Results posted: 2009-03-25

Locations

1 site across 1 country: United States