Clinical Trial: A Study of the Safety of IMOVAX Polio™ in China

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

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

Brief Summary:

This study is designed to obtain post-marketing safety data on IMOVAX Polio™ vaccine in China.

Primary Objective: To describe the safety profile after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age in population aged over 2 months old living in the study city China.


Detailed Summary: Study participants will receive a single dose of IMOVAX Polio™ vaccine at 2, 3, and 4 months of age, respectively. Each participant will make a total of 7 visits. Safety will be monitored at each visit and up to 30 days after each vaccination.
Sponsor: Sanofi

Current Primary Outcome: The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination. [ Time Frame: Day 0 to Day 30 post-vaccination ]

Solicited injection site reactions: tenderness, erythema, and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: November 17, 2010
Date Started: November 2010
Date Completion:
Last Updated: August 2, 2012
Last Verified: August 2012