This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route. Primary Objective: * To demonstrate lot consistency of the Fluzone ID manufacturing process. * To provide information concerning the immune response of Fluzone ID. Secondary Objectives: Safety * To describe the safety profile of subjects who receive of Fluzone ID.
Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere formulation will be administered intradermally (ID) using the Becton Dickinson Micro Injection System.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
4,292
0.1 mL, Intradermal
0.1 mL, Intradermal
0.1 mL, Intradermal
0.5 mL, Intramuscular
Unnamed facility
Hoover, Alabama, United States
Unnamed facility
Huntsville, Alabama, United States
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Chandler, Arizona, United States
Unnamed facility
Mesa, Arizona, United States
Unnamed facility
Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines
The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay
Time frame: Baseline (Day 0) and 28 Days post-vaccination
Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination.
Time frame: 28 Days post-vaccination
Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM
The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroprotection was defined as a HAI antibody titer ≥ 1:40.
Time frame: Before and 28 Days post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Time frame: Day 0 up to 7 Days post vaccination
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Phoenix, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Fountain Valley, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Milford, Connecticut, United States
...and 39 more locations