Phase III, Stratified, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Doses of aH5N1 When Administered to Adult and Elderly Subjects With and Without Underlying Medical Conditions.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 540
- 试验地点
- 12
- 主要终点
- Percentage of subjects with an HI titer ≥1:40
研究概览
简要总结
Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18 through 60 years of age) and elderly (≥61 years of age) subjects with and without underlying medical conditions.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Male and female individuals 18 years of age and older at the time of enrollment who are mentally competent, willing and able to understand the nature and risks of the proposed study, and able to sign the consent form prior to study entry;
- •Individuals who are able to comply with all study procedures and requirements;
- •Healthy volunteers and volunteers specifically with underlying COPD, cardiovascular disease, diabetes mellitus, peripheral vascular disease, or renal impairment may be eligible;
- •Please contact the site for additional eligibility criteria.
排除标准
- •Individuals who are not able to follow all the required study procedures for the whole period of the study;
- •Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study;
- •Please contact the site for additional eligibility criteria.
结局指标
主要结局
Percentage of subjects with an HI titer ≥1:40
时间窗: day 43
Percentage of subjects achieving seroconversion
时间窗: day 43
Seroconversion is defined as hemagglutination inhibition (HI) ≥1:40 for subjects who were seronegative at baseline \[day 1 HI titer \<1:10\] or a minimum 4-fold increase in HI titer for subjects who were seropositive at baseline \[day 1 HI titer ≥1:10\])
Geometric mean ratios (GMRs) as determined by HI assay
时间窗: day 43
Solicited and unsolicited adverse events
时间窗: day 202
In pooled age groups 18 years of age and older subjects who are healthy or with underlying medical condition who have received aTIV or aH5N1 vaccine.
次要结局
- GMTs as determined by SRH(day 1)
- Geometric mean titers (GMTs) as determined by HI(day 22 (3 weeks after the first vaccination))
- Percentage of subjects with geometric mean area ≥25 mm2(day 22)
- Geometric mean ratios (GMRs) as determined by SRH(day 43 (3 weeks after the second vaccination))
- Percentage of subjects with an HI titer ≥1:40(day 1)
- Percentage of subjects achieving seroconversion(day 43)
- GMRs as determined by HI(day 22)
- GMRs as determined by SRH(day 43)