Influenza Clinical Trial
Official title:
Safety and Immunogenicity Among Adults of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2015-2016 Formulations
The aim of the study is to evaluate the safety and immunogenicity of the 2015-2016
formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults
18 to < 65 years of age, and of the 2015-2016 formulations of Fluzone Quadrivalent and
Fluzone High-Dose vaccines in adults ≥ 65 years of age.
Primary Objective:
- To describe the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone
Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age and the safety of the
2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65
years of age.
Observational Objectives:
- To describe the immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent
and Fluzone Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age and the
immunogenicity of the 2015-2016 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 Quadrivalent, and Fluzone High-Dose) in the
applicable age group with the historical requirements of the CHMP NfG CPMP/BWP/214/96.
Adults age 18 to < 65 years will be randomly assigned to receive either Fluzone Quadrivalent
or Fluzone Intradermal Quadrivalent vaccine and adults age ≥ 65 years will be randomly
assigned to receive either Fluzone Quadrivalent or Fluzone High-Dose vaccine. All subjects
will receive a single dose of their randomly assigned vaccine.
They will be followed from Visit 1 to Visit 2 for evaluation of safety outcomes. Solicited
adverse reactions 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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