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A Phase 2 Study to Evaluate t...

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

Last Updated: 2024-09-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2977 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-30

Study Completion Date

2023-08-31

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.

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Detailed Description

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Conditions

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Influenza A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VIR-2482 (Dose 1)

Group Type EXPERIMENTAL

VIR-2482 (450 mg)

Intervention Type BIOLOGICAL

VIR-2482 450mg given by intramuscular injection

VIR-2482 (Dose 2)

Group Type EXPERIMENTAL

VIR-2482 (1200 mg)

Intervention Type BIOLOGICAL

VIR-2482 1200 mg given by intramuscular injection

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Sterile 0.9% (w/v) sodium chloride solution given by intramuscular injection

Interventions

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VIR-2482 (450 mg)

VIR-2482 450mg given by intramuscular injection

Intervention Type BIOLOGICAL

VIR-2482 (1200 mg)

VIR-2482 1200 mg given by intramuscular injection

Intervention Type BIOLOGICAL

Placebo

Sterile 0.9% (w/v) sodium chloride solution given by intramuscular injection

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes