NCT00258843

Safety of Imovax Polio in Chinese Infants and Children

Clinical Safety Evaluation Study of the Sanofi Pasteur's Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered as a Single Booster Dose at 18 Months of Age in Healthy Chinese Children, and as the First Dose of Primary Vaccination at 2 Months of Age in Healthy Chinese Infants.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Months – 18 Months
• Healthy volunteers: Accepted

Summary

To describe the tolerance in terms of occurrence of serious adverse reactions and severe adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX Polio™ administered in children and infants.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated Poliomyelitis vaccine	0.5 mL, intramuscular (IM)
BIOLOGICAL	Inactivated Poliomyelitis vaccine	0.5 mL, IM

Timeline

• Start date: 2005-11-01
• Primary completion: 2006-02-01
• Completion: 2006-04-01
• First posted: 2005-11-28
• Last updated: 2014-01-22

Locations

1 site across 1 country: China