drugset / Trial / NCT01041573
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population
RandomizedParallel-groupOpen-labelPrevention
Summary
The primary objective is to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28 days interval up to Month 7 after the first IC51 vaccination in a pediatric population from endemic regions.
Timeline
- Start
- 2010-03
- Primary completion
- 2011-02
- Completion
- 2011-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | HAVRIX 720 | Vaccine | 0.5 ml | Intramuscular |
| Subject | IC51 | Vaccine | 3 ug | Intramuscular |
| Subject | IC51 | Vaccine | 6 ug | Intramuscular |
| Comparator | Prevnar 13 | Vaccine | 0.5 ml | Intramuscular |