The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,268
A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
North Central Arkansas Medical Association
Mountain Home, Arkansas, United States
Covance CRU, Inc
Boise, Idaho, United States
The University of Iowa
Iowa City, Iowa, United States
Geometric Mean Titer 21 Days After the Study Vaccination
Time frame: 21 days after vaccination
Percentage of Participants With Seroconversion 21 Days After the Study Vaccination
Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
Time frame: 21 days after vaccination
Frequency and Intensity of Local and Systemic Solicited Symptoms
Time frame: 5 days after vaccination
Duration of Local and Systemic Solicited Symptoms
Time frame: 5 days after vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Abbreviation UAE stands for Unsolicited Adverse Event.
Time frame: 21 days after vaccination
Serious Adverse Events
Time frame: 180 days after vaccination
New Onsets of Chronic Illness
A NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to the study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).
Time frame: 180 days after vaccination
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Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
Saint Louis University Medical Center
St Louis, Missouri, United States
University of Rochester School of Medicine and Dentistry
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Covance CRU, Inc.
Portland, Oregon, United States
Primary Physicians Research, Inc.
Pittsburgh, Pennsylvania, United States
...and 3 more locations