Primary Objective: To describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects. Secondary Objective: To describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.
This is a multi-center study in healthy adult subjects. All subjects will receive a single dose of one of the influenza vaccine formulations and will provide blood samples for immunogenicity assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
729
0.5 mL, Intramuscular
1.0 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Hoover, Alabama, United States
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Tucson, Arizona, United States
Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.
Time frame: Days 0 and 21 post-vaccination
Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination.
Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)
Time frame: Day 21 post-vaccination
Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.
Seroconversion: For participants with a Day 0 pre-vaccination titer \< 10 (1/dil), titer ≥ 40 (1/dil) on Day 21. Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21.
Time frame: Day 21 post-vaccination
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.
Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration. Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors.
Time frame: Day 0 up to Day 7 post-vaccination
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Unnamed facility
Milford, Connecticut, United States
Unnamed facility
Pinellas Park, Florida, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Wichita, Kansas, United States
Unnamed facility
Kansas City, Missouri, United States
Unnamed facility
Springfield, Missouri, United States
Unnamed facility
Cary, North Carolina, United States
...and 5 more locations