Post-licensure Safety Study of IMOJEV® in Thailand
This trial is active, not recruiting.
|Treatments||imojev®: live attenuated japanese encephalitis chimeric virus vaccine|
|Sponsor||Sanofi Pasteur, a Sanofi Company|
|Start date||November 2013|
|End date||April 2015|
|Trial size||10000 participants|
|Trial identifier||NCT01981967, JEC17, U1111-1127-7052|
The aim of this study is to further characterize the safety profile of IMOJEV®.
- To describe serious adverse events (SAEs, including adverse events of special interest [AESIs]) up to 60 days after administration of one dose of IMOJEV®.
- To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after administration of one dose of IMOJEV®.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Bangkok, Thailand 10330||not available||no longer recruiting|
|Bangkok, Thailand 10400||not available||no longer recruiting|
|Chiang Mai, Thailand 50200||not available||no longer recruiting|
|Khon Kaen, Thailand 40002||not available||no longer recruiting|
|Nakornnayok, Thailand 26120||not available||no longer recruiting|
|Nonthaburi, Thailand 11120||not available||no longer recruiting|
|Pathumthani, Thailand 12120||not available||no longer recruiting|
|Songkla, Thailand 90110||not available||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
Number and nature of Serious Adverse Events (including Adverse Events of Special Interests) reported following a primary or booster vaccination with IMOJEV® vaccine
time frame: Day 0 up to Day 60 post-vaccination
Number and nature of Grade 3 systemic AEs reported after vaccination following a primary or booster vaccination with IMOJEV® vaccine
time frame: 30 minutes post-vaccination
Male or female participants from 9 months up to 4 years old.
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.
|Official title||Post-licensure, Phase IV, Safety Study of IMOJEV® in Thailand|
|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.|
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