Post-licensure Safety Study of IMOJEV® in Thailand

Phase 4

Completed

• Conditions: Japanese Encephalitis

• Registration Number: NCT01981967
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-13
• Primary Completion: 2015-04
• Study Completion: 2015-10
• Status Verified: 2016-03
• Results First Submitted: 2016-03-31
• Results First Submitted QC: 2016-03-31
• Last Update Submitted: 2016-03-31
• Results First Posted: 2016-05-04
• Last Update Posted: 2016-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®	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.