Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

Study Overview
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Brief Summary
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The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.

Detailed Description
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This is a randomized, controlled, multi-center, double blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years. 624 subjects will be enrolled at approximately 6 sites in study centers in Austria and Germany.

Official Title
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Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.

Conditions
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Japanese Encephalitis

Intervention / Treatment
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* Biological: IC51


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Male and female 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 HIV, drug addiction including alcohol dependence

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IC51 Group A<br>IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches | Biological: IC51<br>* 6 mcg, intramuscularly [i.m.], 0.5 mL<br>* Other names: Japanese Encephalitis purified inactivated vaccine;|
| Active Comparator: IC51 Group B<br>IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches | Biological: IC51<br>* 6 mcg, intramuscularly [i.m.], 0.5 mL<br>* Other names: Japanese Encephalitis purified inactivated vaccine;|
| Active Comparator: IC51 Group C<br>IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches | Biological: IC51<br>* 6 mcg, intramuscularly [i.m.], 0.5 mL<br>* Other names: Japanese Encephalitis purified inactivated vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMT for Anti-JEV Neutralizing Antibody | Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2. | day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability | study duration | 
| SCR for Anti-JEC Neutralizing Antibody Titer |  | day 56 |