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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05567783
Recruitment Status : Active, not recruiting
First Posted : October 5, 2022
Last Update Posted : December 20, 2022
Sponsor:
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Influenza A Biological: VIR-2482 (dose 1) Biological: VIR-2482 (dose 2) Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 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
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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




Primary Outcome Measures :
  1. 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 ]
  2. Occurrence of adverse events (AEs) [ Time Frame: Up to Week 84 ]
  3. Occurrence of serious adverse events (SAEs) [ Time Frame: Up to Week 84 ]
  4. Occurrence of adverse events of special interest (AESI) [ Time Frame: Up to Week 84 ]
  5. 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

  6. 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


Secondary Outcome Measures :
  1. Proportion of participants with CDC-defined ILI with confirmed influenza A (by RT-PCR) [ Time Frame: Up to Week 84 ]
  2. Proportion of participants with WHO-defined ILI with confirmed influenza A (by RT-PCR) [ Time Frame: Up to Week 84 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
Show Show 51 study locations
Sponsors and Collaborators
Vir Biotechnology, Inc.
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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: December 20, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vir Biotechnology, Inc.:
Flu
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases