Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,952
- 试验地点
- 8
- 主要终点
- Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza
研究概览
简要总结
The purpose of this study is to evaluate the absolute (versus placebo) and relative (one vaccine compared to the other) efficacies of the live attenuated and inactivated influenza vaccines in preventing laboratory confirmed symptomatic influenza caused by circulating strains whether similar or dissimilar to strains included in the vaccines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult men and women
- •Age 18-49 years
- •Who reside geographically close to one of the four study sites in Michigan
排除标准
- •Persons with any of the health conditions for which the inactivated vaccine is recommended
- •Persons for whom either vaccine is contraindicated
研究组 & 干预措施
TIV
the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
干预措施: Fluzone (Biological)
LAIV
live-attenuated influenza vaccine Flumist, manufactured by MedImmune
干预措施: Flumist (Biological)
Placebo
Physiologic saline administered as a nasal spray or intramuscular injection
干预措施: Physiologic saline (Other)
结局指标
主要结局
Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza
时间窗: one influenza season - 2007-2008
次要结局
- Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection(Time between prevaccination visit and postvaccination visit; typically about 30 days.)
- Immune Response to Vaccination and Infection(Postvaccination to postseason visit; typically about 3 months.)
- Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion.(Time between prevaccination and postvaccination, typically about 30 days.)
研究者
Arnold S. Monto
Principal Investigator
University of Michigan