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NCT00595309 Clinical Trial

Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

Japanese Encephalitis Clinical Trial

Official title:
Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 on Long Term Immunogenicity. An Uncontrolled, Open-label Phase 3 Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00595309
Other study ID # IC51-311
Secondary ID
Status Completed
Phase Phase 3
First received January 4, 2008
Last updated May 5, 2014
Start date December 2007
Est. completion date October 2009

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 assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.

Recruitment information / eligibility
Status Completed
Enrollment 198
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Main Inclusion Criteria:

- Healthy adults who completed the primary immunization in study IC51 309

- Male and female healthy subjects 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• IC51
IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization

Locations
Country Name City State
Austria Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie Vienna
Austria Zentrum für Reisemedizin, Dependance für klinische Studien Vienna
Germany Berliner Zentrum Reise- und Tropenmedizin Berlin

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 Seroconversion Rate at Month 12 after booster No
Secondary Safety and Adverse Events up to Month 12 after booster Yes
Secondary Seroconversion at D28 and Month 6 after booster No
Secondary Geometric Mean Titer D28, Month 6 and Month 12 after booster No
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
Completed NCT00594958 - Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51 Phase 3
Completed NCT00595790 - Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51 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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Completed NCT00595270 - Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 Phase 3
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