At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 Formulation)
In Brief
A Phase 4 clinical trial evaluating Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative for Influenza. Completed, enrolled 60 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
0.25 mL, Intramuscular (Pediatric Dose, 2013-2014 formulation)
0.5 mL, Intramuscular (2013-2014 formulation)