Trials / Completed
CompletedNCT00314145
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
A Multicentre, Randomized, Double-blind, Phase III Study of The Comparative Immunogenicity, Safety and Tolerability of Two Japanese Encephalitis Vaccines (ChimeriVax™-JE and JE-VAX®)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 820 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ChimeriVax™-JE | 0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline) |
| BIOLOGICAL | JE-VAX® | 0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline) |
Timeline
- Start date
- 2005-11-01
- Primary completion
- 2006-06-01
- Completion
- 2006-11-01
- First posted
- 2006-04-13
- Last updated
- 2012-12-06
- Results posted
- 2012-12-05
Locations
10 sites across 2 countries: United States, Australia
Source: ClinicalTrials.gov record NCT00314145. Inclusion in this directory is not an endorsement.