Trials / Completed
CompletedNCT00605085
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,675 (actual)
- Sponsor
- Valneva Austria GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged \> or = 18 years
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Japanese Encephalitis purified inactivated vaccine (IC51) | IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28 |
| BIOLOGICAL | Placebo | Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28 |
Timeline
- Start date
- 2005-10-01
- Completion
- 2006-11-01
- First posted
- 2008-01-30
- Last updated
- 2024-03-21
- Results posted
- 2012-11-20
Source: ClinicalTrials.gov record NCT00605085. Inclusion in this directory is not an endorsement.