A Phase 1, Observer-blinded, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- KBio Inc
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Solicited administration site reactions
研究概览
简要总结
This is an observer-blinded, randomized, placebo-controlled, parallel group study to evaluate safety and immunogenicity of TAP-V001 quadrivalent influenza vaccine in healthy adult subjects.
详细描述
Subjects will be screened up to 14 days (Day -14 to Day 0) before randomization.
On the planned day of vaccination (Day 1), subjects will be randomized in a 1:1:1:1 ratio (N = 30 subjects/group) to receive study vaccine or placebo by intramuscular (IM) injection.
Approximately 5 subjects per group (N = 20) will be enrolled in parallel initially, and safety data through Day 8 will be collected. An Independent Data Monitoring Committee (IDMC) will convene to review Day 8 safety data before any additional subjects will be enrolled. If there are no safety concerns in the IDMC meeting, study enrollment will continue.
Blood and serum samples for safety laboratory tests and HAI titers will be obtained at baseline on Day 1 before administration of vaccine dose and after vaccination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 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
Solicited administration site reactions
时间窗: 7 days after vaccination
Occurrences of Adverse Events
Solicited systemic events
时间窗: 7 days after vaccination
Occurrences of Adverse Events
次要结局
- Number of Serious Adverse Events and Medically Attended Events(181 days after vaccination)
- Number of Unsolicited Adverse Events(43 days after vaccination)
- Vaccine HAI antibody Titers(Day 1, 29, 43, 181)