Trials / Completed
CompletedNCT00319592
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX
Randomized, Double-blind, Phase II Study of the Safety, Tolerability and Immunogenicity Following Administration of Live Attenuated JE Vaccine (ChimeriVax™ JE) Compared With Mouse Brain-derived Inactivated JE Vaccine (JE VAX®).
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 48 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 ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and several wild types strains after completion of vaccination course.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ChimeriVax™-JE vaccine | 0.5 mL, subcutaneously |
| BIOLOGICAL | JE-VAX® vaccine | 1.0 mL, subcutaneously |
Timeline
- Start date
- 2005-05-01
- Primary completion
- 2006-09-01
- Completion
- 2006-09-01
- First posted
- 2006-04-27
- Last updated
- 2012-08-20
- Results posted
- 2012-08-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00319592. Inclusion in this directory is not an endorsement.