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NCT00595465 Clinical Trial

Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

Japanese Encephalitis Clinical Trial

Official title:
Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00595465
Other study ID # IC51-310
Secondary ID
Status Completed
Phase Phase 3
First received January 4, 2008
Last updated May 5, 2014
Start date December 2007
Est. completion date June 2008

Study information
Verified date May 2014
Source Valneva Austria GmbH
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-InstitutAustria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial Summary

The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody

Recruitment information / eligibility
Status Completed
Enrollment 389
Est. completion date June 2008
Est. primary completion date February 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Main Inclusion Criteria:

- Male and female healthy adults aged at least 18 years, with written informed consent and either no childbearing potential or negative pregnancy test

Main Exclusion Criteria:

- History of immunodeficiency or immunosuppressive therapy,

- Known Human Immunodeficiency Virus (HIV); OR

- Drug addiction including alcohol dependence

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Japanese Encephalitis purified inactivated vaccine
IC51 6 mcg i.m. injection on Day 0 and Day 28

Locations
Country Name City State
Austria Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie Vienna
Germany Berliner Zentrum Reise- und Tropenmedizin Berlin
Germany Klinikum der Universität München, Abteilung für Infektions- und Tropenmedizin Munich
Germany Klinik und Poliklinik für Innere Medizin der Universität Rostock Rostock

Sponsors (1)
Lead Sponsor Collaborator
Valneva Austria GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody Day 56 No
Secondary Seroconversion Rate Day 56 No
Secondary Safety and Adverse Events Day 56 Yes
See also
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Recruiting NCT05568953 - An Experimental Medicine Decipher of a Minimum Correlate of Cellular Immunity Phase 2
Completed NCT00776230 - Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling Phase 3
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Completed NCT00596271 - Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440 Phase 3
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Completed NCT01246479 - Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study Phase 3
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