A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A
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ClinicalTrials.gov Identifier: NCT05567783 |
Recruitment Status :
Terminated
(VIR-2482 did not achieve its primary efficacy endpoint in the prevention of seasonal Influenza A illness via intramuscular administration.)
First Posted : October 5, 2022
Last Update Posted : September 18, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza A | Biological: VIR-2482 (dose 1) Biological: VIR-2482 (dose 2) Biological: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2985 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |
Actual Study Start Date : | October 30, 2022 |
Actual Primary Completion Date : | May 5, 2023 |
Actual Study Completion Date : | August 31, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: VIR-2482 (Dose 1) |
Biological: VIR-2482 (dose 1)
VIR-2482 given by intramuscular injection |
Experimental: VIR-2482 (Dose 2) |
Biological: VIR-2482 (dose 2)
VIR-2482 given by intramuscular injection |
Placebo Comparator: Placebo |
Biological: Placebo
Sterile 0.9% (w/v) sodium chloride solution given by intramuscular injection |
- Proportion of participants with protocol-defined ILI with confirmed influenza A (by reverse transcription-polymerase chain reaction [RT-PCR]) [ Time Frame: Up to Week 84 ]
- Occurrence of adverse events (AEs) [ Time Frame: Up to Week 84 ]
- Occurrence of serious adverse events (SAEs) [ Time Frame: Up to Week 84 ]
- Occurrence of adverse events of special interest (AESI) [ Time Frame: Up to Week 84 ]
- Percentage of Participants with Abnormalities in Vital Signs [ Time Frame: Up to Week 84 ]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
- Percentage of Participants with Clinically significant Abnormalities in Clinical Laboratory Tests [ Time Frame: Up to Week 84 ]Percentage of participants with abnormalities in clinical laboratory test (including hematology, Chemistry, Coagulation, and Urinalysis) will be reported
- Proportion of participants with CDC-defined ILI with confirmed influenza A (by RT-PCR) [ Time Frame: Up to Week 84 ]
- Proportion of participants with WHO-defined ILI with confirmed influenza A (by RT-PCR) [ Time Frame: Up to Week 84 ]
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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05567783
Responsible Party: | Vir Biotechnology, Inc. |
ClinicalTrials.gov Identifier: | NCT05567783 |
Other Study ID Numbers: |
VIR-2482-4002 |
First Posted: | October 5, 2022 Key Record Dates |
Last Update Posted: | September 18, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Flu |
Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections |
RNA Virus Infections Virus Diseases Respiratory Tract Diseases |