Status:
COMPLETED
Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling
Lead Sponsor:
Valneva Austria GmbH
Conditions:
Japanese Encephalitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective is to assess immunogenicity of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antib...
Detailed Description
Open-label, multicenter, phase 3 study assessing immunogenicity at various time points throughout the shelf-life of a commercial batch of IC51 (Batch IC51/07F/008) The study population consists of mal...
Eligibility Criteria
Inclusion
- Male and female healthy adults aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test.
Exclusion
- History of immunodeficiency or immunosuppressive therapy, known HIV infection, drug addiction including alcohol dependence, prior vaccination against JE
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT00776230
Start Date
September 1 2008
End Date
June 1 2010
Last Update
May 4 2016
Active Locations (3)
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1
Zentrum für Reisemedizin
Vienna, Vienna, Austria, 1090
2
Universitätsklinikum Rostock
Rostock, Rostock, Germany, 18057
3
Berliner Zentrum Reise- und Tropenmedizin
Berlin, State of Berlin, Germany, 10117