The purpose of this study is to demonstrate the effectiveness (seroprotection and seroconversion as measured by the hemagglutination inhibition \[HI\] assay) of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine in adults 50 years of age and older. Subjects will be randomized in a double-blind fashion to receive a single intramuscular injection of either the investigational vaccine or a licensed egg-derived seasonal influenza vaccine. Blood will be drawn from all subjects for a determination of HI antibody titers on Days 0 and 21, body temperature and injection site reactions will be monitored daily for 7 days. In addition, subjects will be monitored for adverse events and rises in body temperature until Day 21 and again until Day 180.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
3,208
Single intramuscular injection
Single intramuscular injection
Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, United States
Benchmark Research, San Francisco
Sacramento, California, United States
California Research Foundation
San Diego, California, United States
Benchmark Research San Francisco
San Francisco, California, United States
Percentage of Subjects With Seroconversion Antibody Titer
The rate of subjects vaccinated that demonstrate seroconversion via hemagglutination inhibition (HI) antibody titer to each of the three antigens contained in the vaccine 21 days after vaccination. Seroconversion is defined as a ≥ 4-fold increase in HI antibody titer from baseline or a HI antibody titer ≥ 40 when there is no detectable HI antibody titer (HI antibody titer \< 10) at baseline.
Time frame: 21 days
Percentage of Subjects With Seroprotective Antibody Titer
The rate of subjects vaccinated that achieve a reciprocal HI antibody titer of 40 or higher 21 days after vaccination for each of the three antigens contained in the vaccine.
Time frame: 21 days
Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination
Time frame: 21 days
Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline
Change in geometric mean of titers at day 21 compared to baseline
Time frame: 21 days
Rate of Subjects Experiencing Any Injection Site Reactions Until the Day 21 Visit After Vaccination
Time frame: 21 days
Rate of Subjects Experiencing Systemic Reactions Until the Day 21 Visit After Vaccination
Time frame: 21 days
Rate of Subjects Experiencing Any Systemic Adverse Events During the Entire 180 Day Follow-up Period
Time frame: 180 days
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Clinical Research of South Florida
Coral Gables, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
...and 20 more locations