NCT02608502已完成3 期
A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novavax
- 入组人数
- 11,850
- 试验地点
- 120
- 主要终点
- Numbers and percentages of subjects with moderate-severe RSV-LRTD
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of the RSV F vaccine at a dose of 135µg via intramuscular (IM) injection in the prevention of moderate-severe RSV-associated lower respiratory tract disease (RSV-LRTD) in older adults ≥ 60 years of age.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females ≥60 years of age who are ambulatory and live in the community, or in assisted-living or long-term care residential facilities that provide minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. Subjects may have one or more chronic medical diagnoses, but should be clinically stable as assessed by:
- •Absence of changes in medical therapy within one month due to treatment failure or toxicity,
- •Absence of medical events qualifying as SAEs within one month of the planned vaccination on Day 0, and
- •Absence of known, current, and life-limiting diagnoses which, in the opinion of the investigator, render survival to completion of the protocol unlikely.
- •Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment.
- •Able to comply with study requirements; including access to transportation for study visits.
- •Access to inbound and outbound telephone communication with caregivers and study staff.
排除标准
- •Participation in research involving investigational product (drug / biologic / device) within 45 days before the planned date of the Day 0 vaccination.
- •History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization.
- •Receipt of any vaccine other than an IIV in the 4 weeks preceding the study vaccination or a pneumococcal vaccine in the 2 weeks preceding the study vaccination; or any RSV vaccine at any time.
- •Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
- •Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
- •Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature ≥38.0°C on the planned day of vaccine administration).
- •Known uncontrolled disorder of coagulation. Potential subjects receiving aspirin, clopidogrel, prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban or warfarin under good control for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or stroke in the setting of atrial fibrillation will NOT be excluded.
- •Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
- •Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic, cognitive, or psychiatric conditions deemed likely to impair the quality of study compliance or safety reporting).
结局指标
主要结局
Numbers and percentages of subjects with moderate-severe RSV-LRTD
时间窗: Day 0 to Day 182
Defined by the presence of at least three (3) of: cough, wheezing (or worsening in baseline wheezing), new sputum production (or increase in baseline sputum production), new (or worsening) shortness of breath, and observed tachypnea (≥20 breaths per minute); plus RT-PCR-confirmed RSV infection documented within five days of symptom onset.
Numbers and percentages of subjects with solicited local and systemic AEs
时间窗: Day 0 to Day 364
Defined as solicited local and systemic AEs over the 7 days post-injection; all adverse events, solicited and unsolicited over 56 days after dosing; and MAEs, SAEs, and SNMCs over one year post dosing.
次要结局
- Number and percentage of subjects with RSV-ARD and/or RSV-LRTD(Day 0 to Day 364)
- Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA(Day 0 to Day 364)
- Numbers and percentages of subjects with RSV-Acute Respiratory Disease (RSV-ARD)(Day 0 to Day 182)
- RSV F protein antibody expressed as ELISA Units (EU).(Day 0 to Day 364)
- Hemagglutination-inhibiting (HAI) antibody titers specific for the viruses in the 2015-16 IIV at Day 28 in the subset of subjects in each treatment group that receive IIV concurrently with study test article.(Day 0 to Day 28)
- Neutralizing antibody titer to at least one RSV/A and one RSV/B virus strain(Day 0 to Day 28)
研究者
研究点 (120)
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