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临床试验/NCT00558649
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.

NanoPass Technologies Ltd0 个研究点目标入组 180 人开始时间: 2007年5月最近更新:
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

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

申办方类型
Industry
责任方
Sponsor

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