PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Aboriginal Children and Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 5
- 主要终点
- Occurrence of adverse events (AEs) for days 0-6 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 aboriginal children and adults. The study will enroll 200 healthy adults (ages 20-59 years) and 75 healthy children (ages 6-35 months). Adults will receive one dose of a licensed H1N1 vaccine and children will receive two doses of a licensed H1N1 vaccine approximately 3 weeks apart. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 3 weeks (adults) or 6 weeks (children).
详细描述
During the first wave of the H1N12009 pandemic in Canada, persons of aboriginal background were more often hospitalized with severe infections than were other Canadians. Among First Nations members the hospitalization rate was 5 times higher than the national average. Common risk factors were young age (children and younger adults) and underlying health conditions. A high proportion of aboriginal adults have health conditions that predispose to adverse influenza outcomes, including diabetes, asthma, obesity and smoking-related lung diseases.
Aboriginals could benefit substantially from timely, effective vaccination against pandemic influenza and are expected to be among the first Canadians to be offered vaccine when available. The vaccine dosing recommendation will be based on limited studies in the general population, leaving open the question of whether aboriginals will respond satisfactorily to the recommended dosing. Unique social and biological factors among aboriginals could affect their responses to vaccination, reducing protection or increasing adverse effects. Thus it would be optimal to evaluate the safety and immunogenicity of the pandemic vaccine among the earliest aboriginal recipients, to inform the subsequent vaccination of other aboriginal groups.
The objectives of this study are two-fold:
- To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of children and adults of aboriginal background (First Nations, Metis and Inuit) with emphasis on subgroups at greatest risk of severe disease.
- To complete this evaluation soon after the pandemic vaccines become available so as to inform the subsequent use of the vaccines in the aboriginal population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health
- •Written informed consent provided by or for the subject
- •Aboriginal ethnicity (First Nations, Metis or Inuit)
- •Adults 20-59 years of age
- •Children 6-35 months of age
排除标准
- •Allergies to eggs, thimerosal or gentamicin sulphate
- •Life-threatening reaction to previous Flu vaccine
- •Bleeding disorder
- •Pregnancy
- •Receipt of blood or blood products in past 3 months
- •Compromised immune system
- •Chronic illness
- •Previous lab-confirmed H1N1/2009 infection
结局指标
主要结局
Occurrence of adverse events (AEs) for days 0-6 after each vaccination
时间窗: Day 7 and Day 21 post vaccination
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
次要结局
- Comparison of baseline and post-immunization antibody titres(Day 21 (adults) and Day 42 (children))
研究者
David Scheifele
Principal Investigator
University of British Columbia