NCT00240877已完成3 期
A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- - The primary endpoint of this study is fever defined as oral temperature ≥101°F
研究概览
简要总结
To assess the safety of a vaccine in healthy adults prior to the release of the trivalent vaccine (FluMist).
详细描述
The primary study objective is to assess the safety of a monovalent vaccine of a new 6:2 reassortant in healthy adults prior to the release of the trivalent vaccine (FluMist). Safety will be demonstrated by similar fever rates (oral temperature ≥101°F) in vaccine and placebo recipients.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-64 years of age (not yet reached their 65th birthday);
- •In good health;
- •Available by telephone;
- •Ability to understand and comply with the requirements of the protocol; and
- •Signed informed consent.
排除标准
- •Any condition, other than age, for which the inactivated influenza vaccine is indicated, including: chronic disorders of the pulmonary or cardiovascular systems, including asthma; chronic metabolic diseases (including diabetes mellitus) renal dysfunction, or hemoglobinopathies which required regular medical follow-up or hospitalization during the proceeding year;
- •Acute febrile (>100.0°F oral) illness or clinically significant respiratory illness within the 14 days prior to enrollment;
- •Hypersensitivity to egg or egg protein;
- •Signs or symptoms of any immunosuppressive or immune deficiency disease, including HIV infection, or ongoing immunosuppressive therapy; or an immunosuppressed individual living in the same household;
- •Participation in another investigational trial within one month prior to enrollment or expected enrollment in another investigational trial during this study; and
- •Any condition that in the opinion of the investigator, might interfere with the vaccine evaluation.
研究组 & 干预措施
2
Placebo Comparator
Placebo
干预措施: Placebo (Other)
1
Experimental
Monovalent vaccine prior to the release of the trivalent vaccine (FluMist).
干预措施: AV024 (Biological)
结局指标
主要结局
- The primary endpoint of this study is fever defined as oral temperature ≥101°F
时间窗: Days 0-7
次要结局
- All other reported reactogenicity events and other adverse events.(After 7 days after vaccination)
研究者
研究点 (1)
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