Trials / Completed
CompletedNCT00594958
Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 639 (actual)
- Sponsor
- Valneva Austria GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.
Detailed description
This is a randomized, controlled, multi-center, double blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years. 624 subjects will be enrolled at approximately 6 sites in study centers in Austria and Germany.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IC51 | 6 mcg, intramuscularly \[i.m.\], 0.5 mL |
Timeline
- Start date
- 2006-09-01
- Primary completion
- 2007-04-01
- Completion
- 2007-09-01
- First posted
- 2008-01-16
- Last updated
- 2024-03-21
- Results posted
- 2014-01-23
Source: ClinicalTrials.gov record NCT00594958. Inclusion in this directory is not an endorsement.