Clinical Trials Directory

Trials / Completed

CompletedNCT00604708

Immunogenicity Study of the Japanese Encephalitis Vaccine IC51

Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 vs. JE-VAX as Vaccines for Japanese Encephalitis in Healthy Subjects

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
867 (actual)
Sponsor
Valneva Austria GmbH · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged \> or = 18 years

Conditions

Interventions

TypeNameDescription
BIOLOGICALIC51IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
BIOLOGICALJE-VAXJE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28

Timeline

Start date
2005-09-01
Primary completion
2006-09-01
Completion
2006-09-01
First posted
2008-01-30
Last updated
2024-03-21
Results posted
2012-11-29

Source: ClinicalTrials.gov record NCT00604708. Inclusion in this directory is not an endorsement.