Influenza Clinical Trial
Official title:
Safety and Immunogenicity Among Adults of Fluzone®, Influenza Virus Vaccines 2012-2013 Formulation (Intradermal and Intramuscular Route)
The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18
years to <65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to
<65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age).
Primary Objective:
- To describe the safety of the 2012 - 2013 formulation of Fluzone and Fluzone
Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2012 -
2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
Observational Objectives:
- To describe the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone
Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of the
2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years
of age.
- To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone,
Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the
requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance
(NfG) CPMP/BWP/214/96.
- To submit remaining available sera from subjects given Fluzone vaccine to the 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 selection and recommendation of strains for
subsequent years' influenza vaccines.
Participants 18 to < 65 years of age will be randomized to receive a dose of either Fluzone or Fluzone Intradermal vaccine and participants ≥ 65 years of age will be randomized to receive a dose of Fluzone or Fluzone High-Dose vaccine. All participants will be followed up for safety and immunogenicity. The duration of participation in the trial will be approximately 21 days. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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