PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine After One andTtwo Doses in Young Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 7
- 主要终点
- Safety and immunogenicity of one and two doses Arepanrix
研究概览
简要总结
The purpose of this study is to compare the safety and effectiveness (immune response) to one or two doses of adjuvanted H1N12009 influenza vaccine in young children. An adjuvant is an additive that can boost the immune response. The study will enroll 300 children (ages 6-35 months). Participants will receive 2 doses of adjuvanted H1N12009 vaccine 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 6 weeks.
详细描述
The goal of this study is to determine if one or two doses of the H1N12009 influenza vaccine are needed in young children, a population group at high risk of influenza infection and subsequent hospitalization.
The objectives of this study are two-fold:
- To compare the safety and immunogenicity of 1 and 2 doses of adjuvanted H1N12009 influenza vaccine in children 6-35 months of age.
- To conduct the trial soon after the vaccines become available and share the observations with health officials and the public as soon as possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent provided for the subject by a parent or legal guardian
- •Children age 6-35 months
排除标准
- •Allergies to eggs, thimerosal, gentamicin sulphate or latex
- •Life-threatening reaction to previous Flu vaccine
- •Bleeding disorder
- •Pregnancy
- •Receipt of blood or blood products in past 3 months
- •Chronic illness that could interfere with trial participation
- •Compromised immune system
- •Previous lab-confirmed H1N12009 infection
- •Receipt of H1N12009 vaccine
- •Receipt of Seasonal Influenza vaccine since March 2009
研究组 & 干预措施
Adjuvanted Arepanrix 2 doses
Two doses of adjuvanted H1N1 Arepanrix vaccine given 3 weeks apart
干预措施: adjuvanted Arepanrix (Biological)
结局指标
主要结局
Safety and immunogenicity of one and two doses Arepanrix
时间窗: Day 7 and Day 21 post vaccination measured at day 42
To compare the safety and immunogenicity of one and two doses of adjuvanted H1N12009 pandemic vaccine in children 6-35 months of age
Rapid Trial
时间窗: Day 42
To conduct this trial soon after the vaccines become available and share observations with health officials and the public as soon as possible
次要结局
未报告次要终点