Influenza Clinical Trial
Official title:
Safety and Immunogenicity Among Adults of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines, 2013-2014 Formulations
The aim of the study is describe the safety and immunogenicity of Fluzone Quadrivalent and
Fluzone Intradermal vaccines in adults 18 to < 65 years of age, and to describe the safety
and immunogenicity of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65
years of age.
Primary Objective:
- To describe the safety of the 2013-2014 formulations of Fluzone Quadrivalent and
Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the safety of the
2013-2014 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults
≥ 65 years of age.
Observational objectives:
- To describe the immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent
and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the
immunogenicity of the 2013-2014 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.
- To submit sera from selected subjects 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 formulation recommendations for subsequent influenza vaccines.
Participants 18 to < 65 years of age on enrollment will be randomized to receive either
Fluzone Quadrivalent or Fluzone Intradermal vaccine. Participants ≥ 65 years of age at
enrollment will be randomized to receive either Fluzone Quadrivalent or Fluzone High-Dose
vaccine.
Solicited adverse event (AE) information will be collected for 7 days after each
vaccination, unsolicited AE and Serious adverse event information will be collected from
Visit 1 to Visit 2. Total duration of participation in the study is approximately 21 days.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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