arge scale 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 5,007 人开始时间: 2015年11月19日最近更新: 2015年12月7日

适应症

试验速览

暂无简介。

•1) Subject is 2 months of age or older (60-89days) when receiving the first dose of polio vaccine.
•2) 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;
•3) Informed consent form obtained by the subject's parent/legal representative.
•4) 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: 5007
•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

•1) Subject with a history of serious illness (i.e., hypersensitivity, seizure, convulsion, encephalopathy diseases, etc.)
•2) Acute medical illness with or without fever within the last 72 hours.
•3) Vaccination planned in the 4 weeks following any trial vaccination (except Diphtheria, Tetanus, Pertussis (DTP), Hib vaccine or Pneumo vaccine)
•4) Participation in another clinical trial at the same time.
•5) Contraindications to vaccination according to IMOVAX Polio™ leaflet.
•6) Subject plan to leave the study sites for at least three months after inclusion.

发起方

Sanofi Pasteur China