NCT00380211已完成3 期
A Randomized, Double-Blind Trial Evaluating the Safety and Immunogenicity of an Influenza Vaccine With Reduced Preservative (FluLaval™ TR) and a Standard Influenza Vaccine (Fluarix®) in Subjects Between 18-60 and Over 60 Years of Age.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 7
- 主要终点
- 21 days after vaccination: seroconversion rate, seroprotection rate,
研究概览
简要总结
The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations.
详细描述
This randomized trial will assess the immune protection offered at Day 21 by FluLaval™ TR, Fluarix® being the comparator. In both groups, immune response will be assessed through a blood test before and 21 days following vaccination. The safety and tolerability of the study vaccine will be contrasted to the comparator vaccine over a period of 42 days following vaccination.
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
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 or female adults (≥18 yrs)
- •Stable health status
- •Provide informed consent
- •Access to direct phone service (NOT a pay phone or a common-use phone service)
- •Eligible females must have a negative pregnancy test
排除标准
- •Febrile illness (>38.0°C oral temperature)
- •High blood pressure (≥140/90 mmHg)
- •Significant acute or chronic
- •Uncontrolled medical or psychiatric illness within 1 month prior to vaccination
- •Immunosuppressive condition (confirmed or suspected)
- •Renal impairment
- •Hepatic dysfunction
- •Complicated insulin-dependent diabetes mellitus
- •Unstable cardiopulmonary disease
- •Blood dyscrasias
- •Cytotoxic, immunosuppressive drug, or glucocorticoids use within 1 month of vaccination (nasal glucocorticoids allowed)
- •History of demyelinating disease
- •Active neurological disorder
- •Significant alcohol or drug abuse
- •Significant coagulation disorder (prophylactic antiplatelet medications allowed)
- •Influenza vaccine administrated within 6 months prior to study vaccination
- •Administration of any other vaccine from 30 days prior to the end of the study
- •Use of non-registered drug within 30 days prior to study vaccination
- •Receipt of immunoglobulins and/or any blood products within 3 months of study vaccination
- •History or suspected allergy to previous influenza vaccine, or to any constituent of FluLaval™ TR and Fluarix®, or reaction to eggs consumption
- •Pregnant or nursing female subjects
- •Female subjects not protected by an acceptable contraception method (except if surgically sterile or post-menopausal)
结局指标
主要结局
21 days after vaccination: seroconversion rate, seroprotection rate,
geometric mean titer fold increase
次要结局
- Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;
- SAEs over the whole study period
研究者
研究点 (7)
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