Clinical Trial: A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Large Scale Safety Study of IMOVAX Polio in Selected Cities in China, an Observational Post Marketing Study

Brief Summary:

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.


Detailed Summary: 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.
Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome: Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination. [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: January 14, 2011
Date Started: December 2010
Date Completion:
Last Updated: March 28, 2013
Last Verified: March 2013