Post-licensure Safety Study of IMOJEV® in Thailand

March 31, 2016 updated by: Sanofi Pasteur, a Sanofi Company

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

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®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10330
      • Chiang Mai, Thailand, 50200
      • Khon Kaen, Thailand, 40002
      • Nakornnayok, Thailand, 26120
      • Nonthaburi, Thailand, 11120
      • Pathumthani, Thailand, 12120
      • Songkla, Thailand, 90110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
0.5 mL, Subcutaneous.
Other Names:
  • IMOJEV®
Active Comparator: 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
Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
0.5 mL, Subcutaneous.
Other Names:
  • IMOJEV®

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Estimate)

May 4, 2016

Last Update Submitted That Met QC Criteria

March 31, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JEC17
  • U1111-1127-7052 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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