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NCT00605085 Clinical Trial

Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

Japanese Encephalitis Clinical Trial

Official title:
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00605085
Other study ID # IC51-302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2005
Est. completion date November 2006

Study information
Verified date March 2024
Source Valneva Austria GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged > or = 18 years

Recruitment information / eligibility
Status Completed
Enrollment 2675
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - At least 18 years of age - Written informed consent obtained prior to study entry Exclusion Criteria: - Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine - History of any previous JE vaccination (e.g. JE-VAX®) - Immunodeficiency including post-organ-transplantation or immunosuppressive therapy - A family history of congenital or hereditary immunodeficiency - History of autoimmune disease - Any acute infections within 2 weeks prior to enrollment - Known or suspected HIV Infection - Pregnancy, lactation or unreliable contraception in female subjects

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Japanese Encephalitis purified inactivated vaccine (IC51)
IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
• Placebo
Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Valneva Austria GmbH

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and Tolerability up to Day 56 calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs) Day 56
Secondary Rates of Serious Adverse Events and Medically Attended Adverse Events until Day 56
Secondary Changes in Laboratory Parameters until Day 56
Secondary SCR and GMT of Subjects With Concomitant Vaccinations until Day 56
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 NCT00604708 - Immunogenicity Study of the Japanese Encephalitis Vaccine IC51 Phase 3
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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 NCT00595270 - Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 Phase 3
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