Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

Study Overview
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Brief Summary
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The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic

Official Title
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Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries. Uncontrolled, Open-label Phase 3 Study

Conditions
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Encephalitis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female healthy children and adolescents aged >=2 months to <18 years at the time of first vaccination Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable Female subjects: either no childbearing potential or negative pregnancy test. For females after menarche willingness to practice a reliable method of contraception. The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7. Exclusion Criteria: Clinical manifestation or history of any Flavivirus disease Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study History of immunodeficiency or immunosuppressive therapy Known HIV, HBV or HCV infection History of hypersensitivity reactions to other vaccines Acute febrile infection at each visit during which the subject receives a vaccination Active or passive immunization within 1 week before and 1 week after each IC51 vaccination.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 17 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: >=2 months to <3 years<br>IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28 | Biological: IC51<br>* 0.25 ml, 2 i.m. vaccinations at Day 0 and 28<br>|
| Experimental: >=3 to <12 years<br>IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28 | Biological: IC51<br>* 0.5 ml, 2 i.m. vaccinations at Day 0 and 28<br>|
| Experimental: >=12 to <18 years<br>IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28 | Biological: IC51<br>* 0.5 ml, 2 i.m. vaccinations at Day 0 and 28<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination | Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination. | until Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination |  | up to Month 7 | 
| Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination |  | 7 days | 
| Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination |  | up to Day 56 and upt to Month 7 | 
| Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination | Laboratory parameters were assessed at the Day 28, Day 56 and Month 7 visit. Endpoint reflects abnormal laboratory parameters assessed as clinically significant by the investigator. | up to Month 7 | 
| SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT) |  | at Day 56 and Month 7 | 
| GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7 |  | at Day 56 and Month 7 | 
| SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups |  | at Day 56 and Month 7 | 
| GMTs at Day 56 and Month 7 Stratified According to Age Groups |  | at Day 56 and Month 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-endemic countries, Pediatric, Japanese Encephalitis Vaccine, to assess immunogenicity of purified inactivated Japanese Encephalitis (JE) vaccine IC51