A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A

Conditions
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Influenza A

Intervention / Treatment
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* Biological: VIR-2482 (dose 1)
* Biological: VIR-2482 (dose 2)
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must be 18 to < 65 years of age, at time of randomization Participants must be in good health, determined from medical history and no clinically significant findings from physical examination, 12-lead electrocardiogram (ECG), vital signs, and laboratory values Exclusion Criteria: History or clinical evidence of conditions considered high risk for developing influenza-related complications History of confirmed influenza infection within 3 months prior to randomization. Febrile illness with or without respiratory symptoms History of malignancy within 5 years or participant is under evaluation for malignancy. Any condition or receipt of any medication contraindicating IM injection, as judged by the investigator. History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis Participant has a clinically significant medical condition, physical exam finding, or abnormal laboratory result. Prior or planned receipt of any influenza vaccine for the upcoming season. Received any investigational agent within 90 days or within 5 half-lives of the investigational agent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIR-2482 (Dose 1)<br> | Biological: VIR-2482 (dose 1)<br>* VIR-2482 given by intramuscular injection<br>|
| Experimental: VIR-2482 (Dose 2)<br> | Biological: VIR-2482 (dose 2)<br>* VIR-2482 given by intramuscular injection<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* Sterile 0.9% (w/v) sodium chloride solution given by intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with protocol-defined ILI with confirmed influenza A (by reverse transcription-polymerase chain reaction [RT-PCR]) |  | Up to Week 84 | 
| Occurrence of adverse events (AEs) |  | Up to Week 84 | 
| Occurrence of serious adverse events (SAEs) |  | Up to Week 84 | 
| Occurrence of adverse events of special interest (AESI) |  | Up to Week 84 | 
| Percentage of Participants with Abnormalities in Vital Signs | Percentage of participants with abnormalities in vital signs (temperature, systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse rate and respiratory rate) will be reported | Up to Week 84 | 
| Percentage of Participants with Clinically significant Abnormalities in Clinical Laboratory Tests | Percentage of participants with abnormalities in clinical laboratory test (including hematology, Chemistry, Coagulation, and Urinalysis) will be reported | Up to Week 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with CDC-defined ILI with confirmed influenza A (by RT-PCR) |  | Up to Week 84 | 
| Proportion of participants with WHO-defined ILI with confirmed influenza A (by RT-PCR) |  | Up to Week 84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flu