drugset / Trial / NCT00604058
Immunogenicity and Safety of Fractional Doses of IPV Intradermally vs Full Doses Intramuscularly
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Inactivated Polio Vaccine | Vaccine | 0.1 ml | Intrathecal |
| Comparator | Inactivated Polio Vaccine | Vaccine | 0.5 ml | Intrathecal |