Post-licensure Safety Study of IMOJEV® in Thailand

Study Overview
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Brief Summary
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The aim of this study is to further characterize the safety profile of IMOJEV®. Primary Objective: To describe serious adverse events (SAEs, including adverse events of special interest [AESIs]) up to 60 days after administration of one dose of IMOJEV®. Secondary Objective: To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after administration of one dose of IMOJEV®.

Detailed Description
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Participants aged 1 year to less than 5 years will be randomized to receive one injection of IMOJEV® either as a primary vaccination or as a booster. Safety data will be collected for 60 days after IMOJEV® vaccination. The duration of each subject's participation in the trial will be 60 days.

Official Title
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Post-licensure, Phase IV, Safety Study of IMOJEV® in Thailand

Conditions
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Japanese Encephalitis

Intervention / Treatment
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* Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
* Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children requiring vaccination against Japanese encephalitis Children aged 9 months to less than 5 years on the day of inclusion In good general health at the time of inclusion Informed consent form has been signed and dated by the parent(s)/legal guardian(s) Subject and parent(s)/legal guardian(s) are able to attend the scheduled visit and any additional visits that may need to be done in case of an SAE (including AESI), and are able to comply with all trial procedures The subject's parent(s)/legal guardian(s) have a telephone number at which they can be contacted throughout the study Exclusion Criteria: Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the vaccination Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination Planned participation in another clinical trial during the present trial period Children previously vaccinated with the live attenuated Japanese encephalitis vaccine CD-JEVAX® (SA14-14-2 LAV) Contraindications to vaccination according to the IMOJEV® Summary of Product Characteristics (SmPC) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study Children who received IMOJEV® as primary vaccination in this study.

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 4 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: Primary Vaccination Group<br>Participants who never received a JE vaccine, or who received a single dose of inactivated JE vaccine, or whose JE vaccination history is unknown or not documented. | Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine<br>* 0.5 mL, Subcutaneous.<br>* Other names: IMOJEV®;|
| Active Comparator: Booster Vaccination Group<br>Participants who received at least 2 doses of inactivated JE vaccine (at least 1 year earlier for the last dose), or received a single dose of IMOJEV®, THAIJEV®, or IMOJEV® MD as part of the routine vaccination schedule (i.e., outside of Study JEC17) at least 1 year earlier | Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine<br>* 0.5 mL, Subcutaneous.<br>* Other names: IMOJEV®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV® |  | 30 minutes post-vaccination up to Day 60 post-vaccination | 
| Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV® |  | Day O up to Day 60 post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV® | Adverse Events of Special Interest (AESIs) included hypersensitivity/allergic reactions, neurological events (including febrile convulsions), and vaccine failure. | Day O up to Day 60 post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Japanese encephalitis, IMOJEV®, Japanese encephalitis chimeric virus vaccine