NCT00389857

Trial to Collect Safety Data and Sera for Immunogenicity Testing

Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2006-2007 Formulation)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 36 Months
• Healthy volunteers: Accepted

Summary

To provide Centers for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Virus Vaccine (Fluzone®)	0.25 mL, Intramuscular (infant/children dose)
BIOLOGICAL	Influenza Virus Vaccine (Fluzone®)	0.25 mL, Intramuscular (infant/children dose)

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-09-01
• Completion: 2008-07-01
• First posted: 2006-10-19
• Last updated: 2016-04-14
• Results posted: 2009-03-24

Locations

1 site across 1 country: United States