The primary purpose of this study is to demonstrate the efficacy of an investigational Vero-cell derived influenza vaccine to prevent infection in an adult population with an influenza virus that is antigenically similar to one of the three strains in the vaccine. All subjects will be randomized to receive a single 0.5 ml intramuscular injection from one of three lots of seasonal Vero-cell derived influenza vaccine or saline placebo. Subjects will be monitored for 180 days following vaccination for occurrence of adverse events. For determining antibody response, subjects will have one blood draw before and one blood draw 21 days after vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
3,670
Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Anaheim, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Clearwater, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Pembroke Pines, Florida, United States
Unnamed facility
South Miami, Florida, United States
Unnamed facility
Chicago, Illinois, United States
...and 24 more locations
Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens
Time frame: 21 days to 180 days after the date of vaccination
The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values
Consistency of each strain across the 3 different lots shown by comparison of the ratios of geometric mean HIA titers at Day 21 between individual lots for the immunogenicity analysis set.
Time frame: 21 Days after vaccination
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination
Time frame: During the entire 180-day follow-up period
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