PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults, Including Randomized Comparison of Concurrent or Delayed Seasonal Influenza Vaccination
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 309
- 试验地点
- 4
- 主要终点
- Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in adults when given at the same time or prior to the seasonal influenza vaccine. The study will enroll 300 adults (ages 20-59 years). Participants will be randomized into 2 groups. One group will receive one dose of a licensed H1N1 vaccine and one dose of the seasonal influenza vaccine at the same time; the second group will receive the seasonal influenza vaccine 3 weeks after receiving the licensed H1N12009 influenza vaccine. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 3-6 weeks depending upon the group assignment.
详细描述
The objectives of this study are two-fold:
- To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of adults, soon after the pandemic vaccine becomes available so as to inform the subsequent use of vaccine in public programs.
- To evaluate the compatibility of co-administered H1N12009 pandemic vaccine and seasonal TIV vaccine in the same group of subjects, as the option of co-administration would be useful for public programs.
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
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Adults 20-59 years of age
排除标准
- •Allergies to eggs, thimerosal, gentamicin sulphate, neomycin
- •Life-threatening reaction to previous Flu vaccine
- •Bleeding disorder
- •Pregnancy
- •Receipt of blood or blood products in past 3 months
- •Chronic illness
- •Compromised immune system
- •Previous lab-confirmed H1N12009 infection
- •Receipt of H1N12009 vaccine
- •Receipt of Seasonal Influenza vaccine since March 2009
结局指标
主要结局
Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination
时间窗: Day 7 and Day 21 post vaccination
Occurrence of adverse events (AEs) for days 0-6 after each vaccination
时间窗: Day 7 and Day 21 post vaccination
次要结局
- Immunogenicity: Comparison of baseline and post-immunization antibody titres(Day 21 post vaccination)
研究者
David Scheifele
Director Vaccine Evaluation Center
University of British Columbia