Influenza Clinical Trial
Official title:
Safety and Immunogenicity Among Adults of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines, 2014-2015 Formulations
The aim of this trial is to evaluate the safety and immunogenicity of the 2014-2015
formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to < 65
years or age, and of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone®
High-Dose vaccines in adults ≥ 65 years of age.
Objectives:
- To describe the safety of the 2014-2015 formulations of Fluzone Quadrivalent and
Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the safety of the
2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in
adults ≥ 65 years of age.
Observational objectives:
- To describe the immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent
and Fluzone® Intradermal vaccines in adults 18 to < 65 years of age and the
immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone
®High-Dose vaccines in adults ≥ 65 years of age.
- To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone®
Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose) in the applicable age group
with the historical requirements of the Committee for Human Medicinal Products (CHMP)
Note for Guidance (NfG) CPMP/BWP/214/96.
Adults 18 to < 65 years of age will be randomly assigned in a 1:1 ratio to receive either Fluzone® Quadrivalent or Fluzone® Intradermal vaccine. Adults ≥ 65 years of age will also be randomly assigned in a 1:1 ratio to receive either Fluzone® Quadrivalent or Fluzone® High-Dose vaccine. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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