NCT00831675

Study of Safety and Immunogenicity of Fluzone® in Healthy Children

Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Influenza Virus Vaccine Fluzone® 2004-2005

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

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

Detailed description

To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Vaccine 2004-2005 Paediatric Formulation	0.25 mL (Day 0 and Day 28), Intramuscular
BIOLOGICAL	Influenza Vaccine 2004-2005 Paediatric Formulation	0.25 mL (Day 0 and Day 28), Intramuscular

Timeline

• Start date: 2004-09-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2009-01-29
• Last updated: 2016-04-14
• Results posted: 2009-08-27

Locations

1 site across 1 country: United States