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

2016-09-20 20:38:21 | BioPortfolio

Summary

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.

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 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.

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Influenza

Intervention

Fluzone Quadrivalent vaccine, 2016 2017 formulation, No Preservative, Fluzone Quadrivalent vaccine, 2016 2017 formulation, No Preservative, Fluzone High Dose, vaccine, 2016 2017 formulation

Location

Bardstown, KY 40004
Kentucky
United States
40004

Status

Recruiting

Source

Sanofi

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-20T20:38:21-0400

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