NCT01278433

A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5,007 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 60 Days – 89 Days
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Polio
• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	IMOVAX Polio™: Inactivated Poliomyelitis Vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-12-01
• Completion: 2012-06-01
• First posted: 2011-01-17
• Last updated: 2013-03-29

Locations

15 sites across 1 country: China