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

Vir Biotechnology

Status and phase: Terminated; Phase 2

Conditions: Influenza A

Treatments: Biological: VIR-2482 (1200 mg); Biological: VIR-2482 (450 mg); Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05567783

VIR-2482-4002

Details and patient eligibility

About

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.

Enrollment: 2,977 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,977 participants in 3 patient groups, including a placebo group

VIR-2482 (Dose 1)

Experimental group

Treatment:

Biological: VIR-2482 (450 mg)

VIR-2482 (Dose 2)

Experimental group

Treatment:

Biological: VIR-2482 (1200 mg)

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo