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The aim of the study is 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.
- 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 subjects (30 subjects 3 to < 9 years of age and 30 subjects 18 to < 65 years of age who receive Fluzone Quadrivalent vaccine, and 30 subjects ≥ 65 years of age who receive Fluzone High-Dose vaccine) to CBER for further analysis by the WHO, the CDC, and the FDA to support formulation recommendations for subsequent influenza vaccines.
All participants will receive a 0.5-mL intramuscular dose of their assigned vaccine at Visit 1. For subjects 3 to < 9 years of age for whom 2 doses of influenza vaccine are recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine (of the same volume) will be administered during Visit 2.
Participants will be followed from Visit 1 to Visit 2 for evaluation of safety outcomes. Solicited adverse event information will be collected for 7 days after vaccination. Unsolicited non-serious adverse events (AEs) and serious adverse events (SAEs) will be collected from Visit 1 to Visit 2, or to Visit 3 for those subjects receiving 2 doses of study vaccine.
Immunogenicity will be evaluated in all subjects prior to vaccination on day 0 (Visit 1) and on day 28 for 3 to < 9 year olds and 21 days for adults 18 years and older, following final vaccination.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Fluzone Quadrivalent vaccine, 2016 2017 formulation, No Preservative, Fluzone Quadrivalent vaccine, 2016 2017 formulation, No Preservative, Fluzone High Dose, vaccine, 2016 2017 formulation
Bardstown, KY 40004
Published on BioPortfolio: 2016-09-20T20:38:21-0400
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