drugset / Trial / NCT00604058

Immunogenicity and Safety of Fractional Doses of IPV Intradermally vs Full Doses Intramuscularly

NCT00604058

Phase 2 Completed 236 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupOpen-labelPrevention

Summary

The present study intends to investigate the use of fractional doses of sanofi pasteur's IMOVAX Polio injected intradermally. The primary objective will be to demonstrate the non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1, 2 and 3) one month after the three-dose primary vaccination administered at 6-10-14 weeks of age.

Timeline

Start
2008-01
Primary completion
2008-09
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Inactivated Polio Vaccine Vaccine 0.1 ml Intrathecal
Comparator Inactivated Polio Vaccine Vaccine 0.5 ml Intrathecal

Indications