NCT00558649已完成不适用
A Pilot, Controlled, Comparative and Single Blinded Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines Administered Intradermally Using Microneedle Injectors as Compared With Standard Dose Intramuscular Flu Vaccines as Reference.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
研究概览
简要总结
The purpose of this study is to determine whether low dose flu vaccines delivered with microneedles into the skin (intradermally) are effective.
详细描述
Influenza vaccination is the primary method for preventing influenza and its severe complications. Previous clinical studies demonstrated that delivery of vaccines intradermally (into the skin) can achieve good efficacy even with lower doses of the vaccine.
Comparison: Low dose flu vaccine delivered intradermally with a microneedle device compared to the standard dose flu vaccine delivered intramuscularly (into the muscle) with a regular needle.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed an Informed Consent
- •No previous immune-related disease
排除标准
- •Significant illness within the previous 4 weeks
- •Subjects who have received an influenza vaccine within the previous 6 months
- •An active viral diseases
- •Pregnant or nursing women
- •Any known contraindication to the study vaccine or vaccine ingredients
研究者
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