A Phase I Study of the Safety and Immunogenicity of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, RSV MEDI ΔM2-2 Lot RSV#002A, Delivered as Nose Drops to Adults 18 to 49 Years of Age, RSV-Seropositive Children 12 to 59 Months of Age, and RSV-Seronegative Infants and Children 6 to 24 Months of Age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- List the individual clinical solicited AEs and other AEs, graded by severity. These will be displayed in tabular format and stratified by group.
研究概览
简要总结
Human respiratory syncytial virus (RSV) is a common cause of upper respiratory tract illnesses as well as more severe lower respiratory illnesses, including bronchiolitis and pneumonia. RSV affects almost all children within the first 2 years of life. This study will evaluate the safety and immune response to the RSV MEDI ΔM2-2 vaccine among adults, RSV-seropositive children, and RSV-seronegative infants and children.
详细描述
The purpose of this study is to evaluate the safety and immune response of the RSV MEDI ΔM2-2 vaccine in the four groups of participants. The study vaccine will be evaluated in adults, in RSV-seropositive children, and in a dose-ranging study in two groups of RSV-seronegative infants and children.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
List the individual clinical solicited AEs and other AEs, graded by severity. These will be displayed in tabular format and stratified by group.
时间窗: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children
Where appropriate, chi-square or Fisher's exact test will be used to determine significant differences between groups
时间窗: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children
Summarize the frequency of solicited adverse events (AEs) and other AEs
时间窗: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children
次要结局
- Where appropriate, the Mann-Whitney U test or Tukey-Kramer multiple comparison post-test will be used to determine significant differences between groups(Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children)
- List the peak titer and duration of virus shed by each individual participant. Data will be displayed in tabular format. Mean peak titer and mean duration of shedding will be calculated.(Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children)
- List the RSV antibody titer pre- and post-vaccination for each individual participant. Data will be displayed in tabular format. Mean antibody titers will be determined.(Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children)
- Determine the infectivity of the vaccine, defined as the proportion of vaccinees who either shed vaccine virus and/or had a fourfold or greater rise in serum antibody titer following vaccination(Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children)