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NCT05567783 Clinical Trial

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

Influenza A Clinical Trial

Official title:
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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05567783
Other study ID # VIR-2482-4002
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 30, 2022
Est. completion date August 31, 2023

Study information
Verified date September 2023
Source Vir Biotechnology, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 2985
Est. completion date August 31, 2023
Est. primary completion date May 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• VIR-2482 (dose 1)
VIR-2482 given by intramuscular injection
• VIR-2482 (dose 2)
VIR-2482 given by intramuscular injection
• Placebo
Sterile 0.9% (w/v) sodium chloride solution given by intramuscular injection

Locations
Country Name City State
United States Investigative Site Anderson South Carolina
United States Investigative Site Anniston Alabama
United States Investigative Site Aurora Colorado
United States Investigative Site Austin Texas
United States Investigative Site Austin Texas
United States Investigative Site Cedar Park Texas
United States Investigative Site Chicago Illinois
United States Investigative Site Cincinnati Ohio
United States Investigative Site Dallas Texas
United States Investigative Site Edmond Oklahoma
United States Investigative Site El Dorado Kansas
United States Investigative Site Elizabethton Tennessee
United States Investigative Site Fort Myers Florida
United States Investigative Site Houston Texas
United States Investigative Site Jupiter Florida
United States Investigative Site Kansas City Missouri
United States Investigative Site Knoxville Tennessee
United States Investigative Site Las Vegas Nevada
United States Investigative Site Las Vegas Nevada
United States Investigative Site Layton Utah
United States Investigative Site Lenexa Kansas
United States Investigative Site Lexington Kentucky
United States Investigative Site Lilburn Georgia
United States Investigative Site Long Beach California
United States Investigative Site Longmont Colorado
United States Investigative Site Meridian Idaho
United States Investigative Site Metairie Louisiana
United States Investigative Site Methuen Massachusetts
United States Investigative Site Miami Florida
United States Investigative Site Miami Florida
United States Investigative Site Mobile Alabama
United States Investigative Site Monroe North Carolina
United States Investigative Site New Orleans Louisiana
United States Investigative Site Norfolk Virginia
United States Investigative Site North Charleston South Carolina
United States Investigative Site Pembroke Pines Florida
United States Investigative Site Pomona California
United States Investigative Site Raleigh North Carolina
United States Investigative Site Rapid City South Dakota
United States Investigative Site Rochester New York
United States Investigative Site San Angelo Texas
United States Investigative Site San Antonio Texas
United States Investigative Site San Diego California
United States Investigative Site South Bend Indiana
United States Investigative Site Spartanburg South Carolina
United States Investigative Site Tempe Arizona
United States Investigative Site Tomball Texas
United States Investigative Site Versailles Kentucky
United States Investigative Site Wichita Kansas
United States Investigative Site Winter Park Florida
United States Investigative Site Yukon Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
Vir Biotechnology, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of participants with protocol-defined ILI with confirmed influenza A (by reverse transcription-polymerase chain reaction [RT-PCR]) Up to Week 84
Primary Occurrence of adverse events (AEs) Up to Week 84
Primary Occurrence of serious adverse events (SAEs) Up to Week 84
Primary Occurrence of adverse events of special interest (AESI) Up to Week 84
Primary 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
Primary 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 Proportion of participants with CDC-defined ILI with confirmed influenza A (by RT-PCR) Up to Week 84
Secondary Proportion of participants with WHO-defined ILI with confirmed influenza A (by RT-PCR) Up to Week 84
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