At a glance
ClinicalIndex Comparison Record- ✓Aged 3 to <9 years or adult aged ≥18 years on day of first study vaccination
- ✓Signed informed consent (≥18 years) or assent (7-<9 years) and parental consent (3-<9 years)
- ✓Able to attend all scheduled visits and comply with trial procedures
- ✕Prior influenza vaccination during 2016-2017 influenza season
- ✕Known or suspected immunodeficiency or recent immunosuppressive therapy (chemotherapy, radiation, or systemic corticosteroids within 6 months)
- ✕Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
- ✕History of Guillain-Barré syndrome
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations
In Brief
A Phase 4 clinical trial evaluating Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative and Fluzone High-Dose, vaccine, 2016-2017 formulation for Influenza. Completed, enrolled 180 participants across 2 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
0.5 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular