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 人开始时间: 2015年11月19日最近更新: 2015年12月7日

试验速览

暂无简介。

•- 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.

发起方

Sanofi Pasteur China