Safety study of IMOVAX Polio in selected cities in China, an observational post marketing study

Sanofi Pasteur China0 个研究点目标入组 800 人2015年11月19日

概览

暂无简介。

注册库

who.int

开始日期

2015年11月19日

结束日期

待定

最后更新

10年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Sanofi Pasteur China

•\- 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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 800
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•\- 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.