Immunogenicity Study of the Japanese Encephalitis Vaccine IC51

Study Overview
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Brief Summary
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The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged > or = 18 years

Official Title
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Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 vs. JE-VAX as Vaccines for Japanese Encephalitis in Healthy Subjects

Conditions
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Japanese Encephalitis

Intervention / Treatment
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* Biological: IC51
* Biological: JE-VAX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Written informed consent obtained prior to study entry Exclusion Criteria: History of clinical manifestation of any flavivirus infection History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis) 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 Immunodeficiency including post-organ-transplantation or immunosuppressive therapy A family history of congenital or hereditary immunodeficiency History of autoimmune disease Any acute infections within 4 weeks prior to enrollment Infection with HIV, Hepatitis B or Hepatitis C Pregnancy, lactation or unreliable contraception in female subjects

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IC51<br>6 mcg (microgram) i.m. (intramuscular) on Day0, 14 and 28 | Biological: IC51<br>* IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28<br>* Other names: Japanese Encephalitis purified inactivated vaccine;|
| Active Comparator: JE-VAX<br>given s.c. on Day 0, 7 and 28 | Biological: JE-VAX<br>* JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56 | SCR: anti-JEV neutralizing antibody titer ≥1:10 | Day 56 | 
| GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56 | GMT: geometric mean of PRNT50 | Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Adverse Events |  | until Day 56 | 
| Immunogenicity at Day 28 |  | Day 28 | 
| Immunogenicity at Day 56 for North America vs. Europe |  | Day 56 | 
| Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age |  | Day 56 |