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 ]
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