NCT00348387

Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 60 Days – 70 Days
• Healthy volunteers: Accepted

Summary

This study is intended to support the registration of IMOVAX Polio in China. The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The objective is to demonstrate that after the 3 doses primary series, in terms of seroprotection rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV dose.

Conditions

• Poliomyelitis
• Polio

Interventions

Type	Name	Description
BIOLOGICAL	Poliomyelitis Vaccine inactivated	0.5 mL, Intramuscular
BIOLOGICAL	Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)	1g dragee, oral

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-09-01
• Completion: 2008-12-01
• First posted: 2006-07-04
• Last updated: 2014-01-22

Locations

2 sites across 1 country: China