The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIR-2482 compared to placebo in preventing influenza A illness in healthy adults 18 to \<65 years of age without pre-existing risk factors for serious complications from influenza infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,977
VIR-2482 450mg given by intramuscular injection
VIR-2482 1200 mg given by intramuscular injection
Sterile 0.9% (w/v) sodium chloride solution given by intramuscular injection
Percentage of Participants With Protocol-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])
Protocol-defined ILI with confirmed influenza A defined as RT-PCR confirmed influenza A with at least one respiratory symptom and at least one systemic symptom
Time frame: Up to 24 Weeks
Number of Participants With Adverse Events (AEs)
Time frame: Up to 26 Weeks
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 26 Weeks
Number of Participants With Adverse Events of Special Interest (AESI)
AESI is anaphylaxis per MedDRA anaphylaxis algorithmic SMQ
Time frame: Up to 26 Weeks
Number of Participants With Vital Sign Abnormalities
Defined as a graded abnormality in systolic blood pressure, diastolic blood pressure, pulse, respiratory rate, or oral temperature as per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials at any time on/after receipt of study intervention.
Time frame: Up to 26 Weeks
Number of Participants With Clinical Laboratory Abnormalities
Defined as graded abnormality in chemistry, hematology, liver function, or urinalysis clinical laboratory values as per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials at any time on/after receipt of study intervention.
Time frame: Up to 26 Weeks
Number of Participants With Solicited Injection Site Reactions
Injection site reactions from the study intervention diary card
Time frame: Up to Day 7 following study intervention administration
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Investigative Site
Anniston, Alabama, United States
Investigative Site
Mobile, Alabama, United States
Investigative Site
Tempe, Arizona, United States
Investigative Site
Long Beach, California, United States
Investigative Site
Pomona, California, United States
Investigative Site
San Diego, California, United States
Investigative Site
Aurora, Colorado, United States
Investigative Site
Longmont, Colorado, United States
Investigative Site
Fort Myers, Florida, United States
Investigative Site
Jupiter, Florida, United States
...and 41 more locations
Number of Participants With Solicited Systemic Reactions
Systemic reactions from the study intervention diary card
Time frame: Up to Day 7 following study intervention administration
Percentage of Participants With CDC-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])
CDC-defined ILI with RT-PCR confirmed influenza A
Time frame: Up to 24 Weeks
Percentage of Participants With WHO-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])
WHO-defined ILI with RT-PCR confirmed influenza A
Time frame: Up to 24 Weeks