drugset / Trial / NCT00885157

Immunogenicity and Safety of a Fractional Booster Dose of IPV Intradermally Versus Full Dose Intramuscularly

NCT00885157

Phase 2 Completed 225 enrolled Sanofi Pasteur, a Sanofi Company
Non-randomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to investigate the use of a fourth fractional booster dose of sanofi pasteur's IMOVAX Polio injected intradermally (using the Mantoux technique) as booster dose between 15 to 18 months of age, in terms of immunogenicity and safety. Objectives: * To describe in each group the immunogenicity of IMOVAX Polio administered intradermally or intramuscularly, one month after the booster dose given at 15-18 months of age in toddlers previously primed with three doses of IMOVAX Polio vaccine during the IPV25 study. * To describe in each group the safety of the booster dose of IMOVAX Polio vaccine administered intradermally or intramuscularly.

Timeline

Start
2009-04
Primary completion
2009-10
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Inactivated Polio Vaccine Vaccine 0.1 ml Other
Subject Inactivated Polio Vaccine Vaccine 0.5 ml Other

Indications