NCT01946425

Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine

Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 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 study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent vaccine in participants aged 6 months to \< 9 years at enrollment, divided into 2 age strata (6 months to \< 36 months and 3 years to \< 9 years) Primary Objective: * To describe the safety of the 2013-2014 formulation of Fluzone Quadrivalent 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 2013-2014 formulation of Fluzone Quadrivalent 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 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 formulation recommendations for subsequent influenza vaccines.

Detailed description

Participants will be assigned to the appropriate age group (6 months to \< 36 months of age or 3 years to \< 9 years of age) based on the subject's age at the time of enrollment. Solicited adverse event (AE) information will be collected for 7 days after each vaccination, unsolicited AE information will be collected from Visit 1 to Visit 2, or to Visit 3 for those subjects receiving 2 doses. Serious adverse event information will be collected from Visit 1 to Visit 2, or Visit 3 for those subjects receiving 2 doses. Immunogenicity will be evaluated in all subjects prior to vaccination on Day 0 (Visit 1) and at Day 28 after the final vaccination using the hemagglutination inhibition technique. For each influenza vaccine strain, pre- and post-vaccination geometric mean titers will be calculated.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative	0.25 mL, Intramuscular (Pediatric Dose, 2013-2014 formulation)
BIOLOGICAL	Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative	0.5 mL, Intramuscular (2013-2014 formulation)

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-12-01
• Completion: 2014-07-01
• First posted: 2013-09-19
• Last updated: 2014-09-25
• Results posted: 2014-09-25

Locations

2 sites across 1 country: United States