Clinical trial NCT01981967: Post-licensure Safety Study of IMOJEV® in Thailand
Official title: Post-licensure, Phase IV, Safety Study of IMOJEV® in Thailand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Japanese Encephalitis
Keywords: Japanese encephalitis
IMOJEV®
Japanese encephalitis chimeric virus vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 10000
Sex: ALL
Minimum age (years): 9
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV®
timeFrame: 30 minutes post-vaccination up to Day 60 post-vaccination
measure: Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV®
timeFrame: Day O up to Day 60 post-vaccination
Secondary outcomes:
measure: Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®
timeFrame: Day O up to Day 60 post-vaccination
Other outcomes:
Locations:
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Khon Kaen
country: Thailand
city: Nakornnayok
country: Thailand
city: Nonthaburi
country: Thailand
city: Pathumthani
country: Thailand
city: Songkla
country: Thailand
Study officials:
affiliation: Sanofi Pasteur SA
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Chotpitayasunondh T, Pruekprasert P, Puthanakit T, Pancharoen C, Tangsathapornpong A, Oberdorfer P, Kosalaraksa P, Prommalikit O, Tangkittithaworn S, Kerdpanich P, Techasaensiri C, Korejwo J, Chuenkitmongkol S, Houillon G. Post-licensure, phase IV, safety study of a live attenuated Japanese encephalitis recombinant vaccine in children in Thailand. Vaccine. 2017 Jan 5;35(2):299-304. doi: 10.1016/j.vaccine.2016.11.062. Epub 2016 Nov 28.