As a result of the safety and immunogenicity data generated from earlier dose-ranging studies, the present formulation has been selected for further development in the elderly. Primary Objective: To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects receiving standard Fluzone®. Secondary Objectives: Immunogenicity: To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®. Safety: To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
817
0.1 mL, Intradermal
0.5 mL, Intramuscular
Unnamed facility
Alabaster, Alabama, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Fountain Valley, California, United States
Unnamed facility
Pinellas Park, Florida, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Springfield, Missouri, United States
Unnamed facility
Brooklyn, New York, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Bensalem, Pennsylvania, United States
Unnamed facility
Grove City, Pennsylvania, United States
...and 7 more locations
Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Time frame: Pre-vaccination and Day 28 post-vaccination
Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40
Time frame: Day 28 post-vaccination
Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.
The serological determinations of total anti influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Time frame: Pre- and Day 28 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Solicited injection site reactions: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Time frame: Day 0 up to 7 days post-vaccination
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