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Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations

NCT02908269 PHASE4 COMPLETED Results posted

The aim of the study was to describe the safety and immunogenicity of the 2016-2017 formulations of Fluzone Quadrivalent vaccine in children 3 to \< 9 years of age and in adults 18 to \< 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥65 years of age. Primary Observational Objectives * To describe the safety of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to \< 9 years of age and adults 18 to \< 65 years of age, and the safety of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age. Observational Objectives: * To describe the immunogenicity of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to \< 9 years of age and adults 18 to \< 65 years of age, and the immunogenicity of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age. * To submit available sera from approximately 90 participants (30 participants 3 to \< 9 years of age and 30 participants 18 to \< 65 years of age who receive Fluzone Quadrivalent vaccine, and 30 participants ≥ 65 years of age who receive Fluzone High-Dose vaccine) to 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.

Details

Lead sponsorSanofi Pasteur, a Sanofi Company
PhasePHASE4
StatusCOMPLETED
Enrolment180
Start dateThu Sep 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionFri Dec 09 2016 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

United States