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NCT00596102 Clinical Trial

Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51

Japanese Encephalitis Clinical Trial

Official title:
Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51. An Uncontrolled Phase 3 Follow-up Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00596102
Other study ID # IC51-303
Secondary ID
Status Completed
Phase Phase 3
First received January 4, 2008
Last updated June 27, 2014
Start date October 2005

Study information
Verified date June 2014
Source Valneva Austria GmbH
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.

Recruitment information / eligibility
Status Completed
Enrollment 3258
Est. completion date
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthy subjects at least 18 years of age

- Written informed consent obtained prior to study entry

- Subjects correctly included and having completed clinical studies IC51-301 (NCT00604708) and IC51-302 (NCT00605085) with at least one vaccination

Exclusion Criteria:

- Inability or unwillingness to provide informed consent and to abide the requirements of the study

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Intervention

Biological:
• Japanese Encephalitis purified inactivated vaccine
Japanese Encephalitis purified inactivated vaccine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Valneva Austria GmbH

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Subjects With Seroconversion Rate (SCR) = 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302 24 months after the first vaccination No
Secondary Percentage of Subjects With Seroconversion Rate (SCR) = 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) 6, 12, 36, 48 and 60 months after 1st vaccination No
Secondary Geometric Mean Titers 6, 12, 36, 48 and 60 months No
Secondary Adverse Events 6, 12, 24, 36, 48 and 60 months after 1st vaccination 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
Completed NCT00596271 - Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440 Phase 3
Completed NCT00604708 - Immunogenicity Study of the Japanese Encephalitis Vaccine IC51 Phase 3
Not yet recruiting NCT01954810 - Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Phase 4
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
Completed NCT00314132 - Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis. Phase 3
Completed NCT00605085 - Safety and Tolerability of the Japanese Encephalitis Vaccine IC51 Phase 3
Completed NCT00595270 - Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 Phase 3
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Completed NCT00314145 - A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX Phase 3
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Unknown status NCT01163123 - Seroepidemiology of Japanese Encephalitis Virus Infection in Hualien, Taiwan N/A
Completed NCT01856205 - Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis Phase 2