Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51

Study Overview
=================
Brief Summary
-----------------
The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged > or = 18 years

Detailed Description
-----------------
This is a multicenter, observer blinded, controlled, randomized phase 3 study. The study population consists of healthy male and female volunteers, aged at least 18 years. Approximately 375 volunteers will be enrolled at approximately 2 to 3 sites.

Official Title
-----------------
Phase 3 Study to Compare a Rapid Immunization Regime With the Standard Regime of IC51 as Vaccine for Japanese Encephalitis

Conditions
-----------------
Japanese Encephalitis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IC51 2 x 6 mcg<br>2 x 6 mcg (microgram) | Biological: IC51<br> <br> * Other names: Japanese Encephalitis purified inactivated vaccine;|
| Active Comparator: IC51 1 x 12 mcg<br>1 x 12 mcg (microgram) | Biological: IC51<br> <br> * Other names: Japanese Encephalitis purified inactivated vaccine;|
| Active Comparator: IC51 1 x 6 mcg<br>1 x 6 mcg (microgram) | Biological: IC51<br> <br> * Other names: Japanese Encephalitis purified inactivated vaccine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCR (Seroconversion Rate) at Day 56 | Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer | day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCR at Day 10, 28 and 35 |  | Day 10, 28 and 35 | 
| GMT at Day 10, 28, 35 and 56 |  | Day 10, 28, 35 and 56 | 
| Safety | AEs, Local and systemic tolerability, Safety laboratory parameters | Study duration |