A Long-Term Safety and Immunogenicity Follow-up of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 147
- 主要终点
- To provide information concerning the immune response of live vaccinia virus (LISTER strain) after primary vaccination.
研究概览
简要总结
The purpose of this study is to provide long-term follow-up immunogenicity and safety data on participants who were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).
Primary Objectives:
Immunogenicity: To yearly describe the vaccinia antibody persistence up to 5 years post-vaccination.
Safety: To follow-up the long-term safety up to 5 years post-vaccination.
详细描述
None of the participants in this study will receive any vaccination as part of the study. All participants will provide blood samples for immunogenicity testing at the 1, 2, 3, 4, and 5 year anniversaries of vaccination. Safety will be assessed for up to 5 years after vaccination, including follow-up of reactions that occurred during Study VVL04 (NCT 00258947).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 25 Years（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
To provide information concerning the immune response of live vaccinia virus (LISTER strain) after primary vaccination.
时间窗: 1 to 5 years post-vaccination
To provide information concerning the safety after primary administration of live vaccinia virus (LISTER strain).
时间窗: 1 to 5 years post-vaccination
次要结局
未报告次要终点