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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2,985
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Protocol-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
VIR-2482 (Dose 1)
干预措施: VIR-2482 (450 mg) (Biological)
VIR-2482 (Dose 2)
干预措施: VIR-2482 (1200 mg) (Biological)
Placebo
干预措施: Placebo (Biological)
结局指标
主要结局
Percentage of Participants With Protocol-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])
时间窗: 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
Number of Participants With Adverse Events (AEs)
时间窗: Up to 26 Weeks
Number of Participants With Serious Adverse Events (SAEs)
时间窗: Up to 26 Weeks
Number of Participants With Adverse Events of Special Interest (AESI)
时间窗: Up to 26 Weeks
AESI is anaphylaxis per MedDRA anaphylaxis algorithmic SMQ
Number of Participants With Vital Sign Abnormalities
时间窗: 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.
Number of Participants With Clinical Laboratory Abnormalities
时间窗: 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.
Number of Participants With Solicited Injection Site Reactions
时间窗: Up to Day 7 following study intervention administration
Injection site reactions from the study intervention diary card
Number of Participants With Solicited Systemic Reactions
时间窗: Up to Day 7 following study intervention administration
Systemic reactions from the study intervention diary card
次要结局
- Percentage of Participants With CDC-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])(Up to 24 Weeks)
- Percentage of Participants With WHO-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])(Up to 24 Weeks)