NCT01758185已完成4 期
Phase 4 Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine
Beijing Center for Disease Control and Prevention2 个研究点 分布在 1 个国家目标入组 3,308 人开始时间: 2011年8月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,308
- 试验地点
- 2
- 主要终点
- Incidence rate of adverse events of the inactivated split influenza vaccine
研究概览
简要总结
The objective of this study was to evaluate the safety and immunogenicity of one inactivated split influenza vaccine, a primarily Chinese-marketed trivalent vaccine.
详细描述
A total of 3308 subjects were stratified equally into four age groups and receive either influenza vaccine or recombinant hepatitis b vaccine (seen as placebo). Systematic and local adverse reactions were reported for 28 d after the vaccination. Antibody levels were detected through hemagglutination inhibition assay before vaccination (Baseline) and 28d after the 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 (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •more than three years in good healthy
排除标准
- •current infectious fever or acute disease
- •upper respiratory infectious symptom within 6m
- •a history of allergy
- •laboratory confirmed influenza
- •autoimmune disease
- •have get influenza vaccine since 2008
结局指标
主要结局
Incidence rate of adverse events of the inactivated split influenza vaccine
时间窗: two years
次要结局
- Antibody titre of the inactivated split influenza vaccine(two years)
研究者
研究点 (2)
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