NCT01691326

Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 8 Years
• Healthy volunteers: Accepted

Summary

The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone vaccine. Objective: * To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to \< 9 years of age. Observational Objectives: * To describe the immunogenicity of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to \< 9 years of age. * To submit remaining available sera from subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support selection and recommendation of strains for subsequent years' influenza vaccines.

Detailed description

All participants will receive Fluzone vaccine during Visit 1. For subjects receiving 2 doses of influenza vaccine, per ACIP guidance, a second dose of Fluzone vaccine will be administered during Visit 2. Total duration of participation in the study is approximately 28 days for participants receiving 1 dose and 56 days for those receiving 2 doses of Fluzone vaccine.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose	0.25 mL dose, Intramuscular
BIOLOGICAL	Fluzone®; Influenza Virus Vaccine, No Preservative	0.5 mL dose, Intramuscular

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-12-01
• Completion: 2013-02-01
• First posted: 2012-09-24
• Last updated: 2014-04-16
• Results posted: 2014-04-16

Locations

2 sites across 1 country: United States