drugset
drugset / Trial / NCT00348387

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

NCT00348387 ↗

Phase 3 Completed 600 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2006-06
Primary completion
2008-09
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Inactivated Polio Vaccine Vaccine 0.5 ml Intramuscular
Comparator Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell) Vaccine 1 g Oral

Indications

poliomyelitis