> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-2-study-to-evaluate-the-efficacy-and-safety-of-vir-0329e0e4-ef6b-4075-a4dc-53ac35f3ed60 > Record changed: 2026-10-13 # A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A NCT05567783 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) Participants 2,977 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) Lead sponsor Vir Biotechnology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) Start date 2022-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) Number of sites 51 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Short title** A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Reason stopped** VIR-2482 1200 mg did not demonstrate efficacy versus placebo in the primary analysis of the primary endpoint Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) ## Dates **Completion date** 2023-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **First posted** 2022-10-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Registry last updated** 2024-09-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Primary completion date** 2023-05-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Start date** 2022-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) ## Size and sites **Actual participants** 2,977 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Participants** 2,977 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Number of sites** 51 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Lead sponsor** Vir Biotechnology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) ## Identifiers **Registry ID** NCT05567783 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **ClinicalTrials.gov ID** NCT05567783 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) ## Outcomes ### Primary outcomes 1. Percentage of Participants With Protocol-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction \[RT-PCR\]) Timeframe: Up to 24 Weeks 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 2. Number of Participants With Adverse Events (AEs) Timeframe: Up to 26 Weeks 3. Number of Participants With Serious Adverse Events (SAEs) Timeframe: Up to 26 Weeks 4. Number of Participants With Adverse Events of Special Interest (AESI) Timeframe: Up to 26 Weeks AESI is anaphylaxis per MedDRA anaphylaxis algorithmic SMQ 5. Number of Participants With Vital Sign Abnormalities Timeframe: Up to 26 Weeks 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. 6. Number of Participants With Clinical Laboratory Abnormalities Timeframe: Up to 26 Weeks 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. 7. Number of Participants With Solicited Injection Site Reactions Timeframe: Up to Day 7 following study intervention administration Injection site reactions from the study intervention diary card 8. Number of Participants With Solicited Systemic Reactions Timeframe: Up to Day 7 following study intervention administration Systemic reactions from the study intervention diary card ### Secondary outcomes 1. Percentage of Participants With CDC-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction \[RT-PCR\]) Timeframe: Up to 24 Weeks CDC-defined ILI with RT-PCR confirmed influenza A 2. Percentage of Participants With WHO-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction \[RT-PCR\]) Timeframe: Up to 24 Weeks WHO-defined ILI with RT-PCR confirmed influenza A Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 64 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) ## Sites - Investigative SiteAnniston, United States - Investigative SiteMobile, United States - Investigative SiteTempe, United States - Investigative SiteLong Beach, United States - Investigative SitePomona, United States - Investigative SiteSan Diego, United States - Investigative SiteAurora, United States - Investigative SiteLongmont, United States - Investigative SiteFort Myers, United States - Investigative SiteJupiter, United States - Investigative SiteMiami, United States - Investigative SiteMiami, United States - Investigative SitePembroke Pines, United States - Investigative SiteWinter Park, United States - Investigative SiteLilburn, United States - Investigative SiteMeridian, United States - Investigative SiteChicago, United States - Investigative SiteSouth Bend, United States - Investigative SiteEl Dorado, United States - Investigative SiteLenexa, United States - Investigative SiteWichita, United States - Investigative SiteLexington, United States - Investigative SiteVersailles, United States - Investigative SiteMetairie, United States - Investigative SiteNew Orleans, United States And 26 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) ## References - PubMed 39036981 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39036981/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567783) ## Related records ### Drugs (1) - [Sonavibart](https://trialight.com/data/asset/sonavibart-f85c5f86-9785-423b-8adf-e1a07f568154.md) ### Lead sponsors (1) - [Vir Biotechnology, Inc.](https://trialight.com/data/company/vir-biotechnology-inc-4e136db5-7823-4056-85d1-f1f37786d9c9.md) ### Conditions (2) - [Influenza](https://trialight.com/data/condition/influenza-ea12369b-7ed6-5f6b-94fe-eb0e56c24def.md) - [Swine influenza](https://trialight.com/data/condition/swine-influenza-a0f3b462-7878-5139-87b1-11e99944a1d8.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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