Safety Study of IMOVAX Polio™ in Selected Cities in China, an Observational Post Marketing Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination.
研究概览
简要总结
This study is designed to obtain post-marketing safety data on IMOVAX Polio™ vaccine in China.
Primary Objective: To describe the safety profile after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age in population aged over 2 months old living in the study city China.
详细描述
Study participants will receive a single dose of IMOVAX Polio™ vaccine at 2, 3, and 4 months of age, respectively. Each participant will make a total of 7 visits. Safety will be monitored at each visit and up to 30 days after each vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Days 至 89 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is more than 2 months (60-89 days) old when receiving the first dose of polio vaccine.
- •Subject's parents/legal representative showed willingness to complete the 3 primary doses fully using IMOVAX Polio™ according to the schedule: one injection at 2, 3, 4 months old, respectively.
- •Informed consent form obtained from the subject's parent/legal representative.
- •Subject plan to live in the selected study sites for at least three months after inclusion.
排除标准
- •Subject with a history of serious illness (e.g., hypersensitivity, seizure, convulsion, encephalopathy diseases)
- •Known or suspected impairment of immunologic function
- •Acute medical illness with or without fever within the last 72 hours
- •Subject plan to leave the study sites for at least three months after inclusion
- •Administration of immune globulin or other blood products within the last three months
- •Participation in another clinical trial at the same time
- •Contraindication to vaccination according to IMOVAX Polio™ leaflet.
研究组 & 干预措施
Study Group
干预措施: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine (Biological)
结局指标
主要结局
The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination.
时间窗: Day 0 to Day 30 post-vaccination
Solicited injection site reactions: tenderness, erythema, and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.
次要结局
未报告次要终点