arge scale safety study of IMOVAX Polio in selected cities in China, an observational post marketing study

Sanofi Pasteur China0 sites5,007 target enrollmentNovember 19, 2015

Overview

No summary available.

Registry

who.int

Start Date

November 19, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Sanofi Pasteur China

•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.