Large Scale 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
- 入组人数
- 5,007
- 试验地点
- 15
- 主要终点
- Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination.
研究概览
简要总结
The aim of the study is to collect post marketing safety data on IMOVAX Polio vaccine in China.
Objective:
To describe serious adverse events 30 days after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age among infants living in the study cities of China.
详细描述
Each study participant will receive an IMOVAX Polio™ injections at 2, 3 and 4 months of age (total of 3 doses) and will be followed up for 30 days after each vaccination.
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
- 60 Days 至 89 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is 2 months of age or older (60-89days) when receiving the first dose of polio vaccine.
- •Subject's parent /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 by 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 (i.e., hypersensitivity, seizure, convulsion, encephalopathy diseases, etc.)
- •Acute medical illness with or without fever within the last 72 hours.
- •Vaccination planned in the 4 weeks following any trial vaccination (except Diphtheria, Tetanus, Pertussis (DTP), Hib vaccine or Pneumo vaccine)
- •Participation in another clinical trial at the same time.
- •Contraindications to vaccination according to IMOVAX Polio™ leaflet.
- •Subject plan to leave the study sites for at least three months after inclusion.
研究组 & 干预措施
Study Group
Participants receiving their first dose of polio vaccine
干预措施: IMOVAX Polio™: Inactivated Poliomyelitis Vaccine (Biological)
结局指标
主要结局
Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination.
时间窗: Up to 30 days after each vaccination
A serious adverse event is defined as any untoward medical occurrence that at any dose (including overdose) results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is an important medical event.
次要结局
未报告次要终点