The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012 formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and older. Objectives: * To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age. * To describe the immunogenicity of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age.
Historically, the annual safety and immunogenicity study of Fluzone vaccine has been conducted in the US in support of licenses held by sanofi pasteur in various countries. Participants will be randomized to receive a dose of either Fluzone® or Fluzone® High-Dose vaccine and will be followed up for safety and immunogenicity. The duration of participation in the trial will be approximately 1 month.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
300
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Colorado Springs, Colorado, United States
Unnamed facility
Council Buffs, Iowa, United States
Unnamed facility
Metairie, Louisiana, United States
Unnamed facility
Springfield, Missouri, United States
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 solicited reactions were defined as: Fever ≥ 39.0°C; Pain, Headache, Malaise and Myalgia, significant, prevents daily activities; Erythema and Swelling \> 100 mm.
Time frame: Day 0 to up to Day 28 post-vaccination
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Unnamed facility
Bensalem, Pennsylvania, United States
Unnamed facility
Austin, Texas, United States