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

Study Summary

The study will evaluate the safety and immunogenicity of the 2014-2015 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to \< 9 years of age. Objective: * To describe the safety of the 2014-2015 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. Observational objectives: * To describe the immunogenicity of the 2014-2015 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 available sera from each subject to Center for Biologics Evaluation and Research (CBER) for further analysis by the WHO, the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.

Primary Outcome

Solicited Injection-site: 6 to \< 36 months - Tenderness, Erythema, and Swelling; 3 to \< 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to \< 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to \< 9 years - Fever, Headache, Malaise, and Myalgia. Grade 3: Fever, \> 39.5˚C (6 to \< 36 months), ≥ 39.0˚C (3 to \< 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, \> 3 hours;

Conditions Studied

Interventions

• BIOLOGICAL Fluzone® Quadrivalent Influenza Vaccine, No Preservative

Study Locations (2)