Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling

Study Overview
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Brief Summary
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The objective is to assess immunogenicity of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antibodies at Day 56 after the first vaccination.

Detailed Description
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Open-label, multicenter, phase 3 study assessing immunogenicity at various time points throughout the shelf-life of a commercial batch of IC51 (Batch IC51/07F/008) The study population consists of male and female healthy subjects, aged at least 18 years. The study will be performed at 3 study centers in Germany and Austria. Three sequential cohorts, each containing 100 subjects, will be enrolled into the study at approximately 12, 18 and 24 months after filling of the commercial batch IC51/07F/008 of IC51

Official Title
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Immunogenicity of a Commercial Batch of the Japanese Encephalitis Vaccine IC51 up to Twenty-four Months Post Filling. An Open-label, Multicenter, 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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Inclusion Criteria: Male and female healthy adults aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test. Exclusion Criteria: History of immunodeficiency or immunosuppressive therapy, known HIV infection, drug addiction including alcohol dependence, prior vaccination against JE

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IC51 ( 12 months post filling)<br>6 mcg ( 12 months post filling) | Biological: IC51<br>* 6 mcg im. at day 0 and day 28<br>* Other names: Japanese Encephalitis vaccine;|
| Active Comparator: IC51 ( 18 months post filling)<br>6 mcg ( 18 months post filling) | Biological: IC51<br>* 6 mcg im. at day 0 and day 28<br>* Other names: Japanese Encephalitis vaccine;|
| Active Comparator: IC51 ( 24 months post filling)<br>6 mcg ( 24 months post filling) | Biological: IC51<br>* 6 mcg im. at day 0 and day 28<br>* Other names: Japanese Encephalitis vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary: 1. Geometric Mean Titers (GMT) at Day 56 |  | 56 days post 1st vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability |  | see above |