Safety of a Quadrivalent Influenza Vaccine (VaxigripTetra™) in Subjects Aged 6 Months and Older in Vietnam
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Number of participants reporting solicited injection site reactions or systemic reactions
研究概览
简要总结
The primary objective of this study is to describe the safety of the Quadrivalent Influenza Vaccine (QIV). Safety is assessed throughout the study period, and includes solicited injection site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse events up to Day 28, and serious adverse events occurring throughout the study.
详细描述
Study duration for previously unvaccinated participants aged 6 months to 8 years is approximately 56 days. Study duration for previously vaccinated participants aged 6 months to 8 years and any participant aged 9 years and older is approximately 28 days.
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 —（Child, Adult, Older 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
Number of participants reporting solicited injection site reactions or systemic reactions
时间窗: Within 7 days after vaccination
Injection site reactions: tenderness/pain, erythema, swelling, induration, and haemorrhage. Systemic reactions: participants ≤ 23 months: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability; participants 2 years and older: fever, headache, malaise, myalgia, and shivering.
次要结局
未报告次要终点