NCT01244464

A Study of the Safety of IMOVAX Polio™ in China

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 60 Days – 89 Days
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Poliomyelitis
• Polio

Interventions

Type	Name	Description
BIOLOGICAL	IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine	0.5 mL, at 2, 3, and 4 months; Intramuscular

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-06-01
• Completion: 2011-12-01
• First posted: 2010-11-19
• Last updated: 2012-08-03

Locations

1 site across 1 country: China