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临床试验/NCT00349037
NCT00349037已完成1 期

A Prospective, Randomised, Double Blind, Placebo-Controlled Study to Assess the Efficacy of a Trivalent (A/New Caledonia/20/99, A/Panama/2007/99, B/Jiangsu/10/20) DNA Influenza Vaccine Administered by Particle Mediated Epidermal Delivery (PMED) Against a Controlled Influenza Virus Challenge.

PowderMed1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2006年9月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
105
试验地点
1
主要终点
Efficacy of the vaccine in preventing symptoms of influenza-like illness

研究概览

简要总结

The purpose of this study is to evaluate how effective the vaccine is at preventing subjects developing flu symptoms after they are directly exposed to flu virus. The study will also evaluate how well the vaccine is tolerated at sites where administrations are given, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body

详细描述

Influenza is a contagious disease of the upper airways and the lungs. It rapidly spreads around the world in seasonal epidemics, killing hundreds of thousands of people and having high economic consequences due to healthcare costs and lost productivity. Each year governments recommend groups who are at risk of influenza or its complications to receive influenza vaccination. Current vaccine supply is not sufficient to meet the demand if this recommendation were to be taken up by all. This study will evaluate PowderMed's Particle Mediated Epidermal Delivery (PMED) DNA vaccine for influenza as a potential alternative to existing vaccine technologies. This study will assess how effective two different PMED vaccine combinations are at preventing subjects developing influenza following exposure to flu virus 56 days after a single dose of vaccine.

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adult volunteers (women must be of non child-bearing potential)
  • Provided written informed consent

排除标准

  • No significant concomitant illness
  • No allergy to gold
  • No immunosuppression due to disease or treatment
  • Pre-existing protective level of antibody against the challenge virus strain

结局指标

主要结局

Efficacy of the vaccine in preventing symptoms of influenza-like illness

次要结局

  • Safety and tolerability - AEs and laboratory tests. Immunogenicity of the vaccine

研究者

发起方
PowderMed
申办方类型
Industry

研究点 (1)

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