NCT00604058

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

Immunogenicity and Safety of Fractional Doses of Sanofi Pasteur's Inactivated Poliomyelitis Vaccine Administered Intradermally vs Full Doses of Inactivated Poliomyelitis Vaccine Administered Intramuscularly in Healthy Philippines Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 42 Days – 50 Days
• Healthy volunteers: Accepted

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.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated Poliomyelitis vaccine (IMOVAX)	Fractional dose (1/5th) 0.1 mL, intradermally
BIOLOGICAL	Inactivated Poliomyelitis vaccine (IMOVAX)	A full dose, 0.5 mL, intramuscular

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-09-01
• Completion: 2008-12-01
• First posted: 2008-01-29
• Last updated: 2014-01-22

Locations

1 site across 1 country: Philippines