Post-licensure Safety Study of IMOJEV® in Thailand

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-10-31

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®.

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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.

Conditions

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Japanese Encephalitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Primary Vaccination Group

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.

Group Type EXPERIMENTAL

IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous.

Booster Vaccination Group

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

Group Type ACTIVE_COMPARATOR

IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous.

Interventions

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IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine

0.5 mL, Subcutaneous.

Intervention Type BIOLOGICAL

IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine

0.5 mL, Subcutaneous.

Intervention Type BIOLOGICAL

Other Intervention Names

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IMOJEV® IMOJEV®

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.

Minimum Eligible Age

9 Months

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes