Post-licensure Safety Study of IMOJEV® in Thailand
Post-licensure, Phase IV, Safety Study of IMOJEV® in Thailand
2 other identifiers
interventional
10,000
1 country
8
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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2013
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 5, 2013
CompletedFirst Posted
Study publicly available on registry
November 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
May 4, 2016
CompletedMay 4, 2016
March 1, 2016
1.4 years
November 5, 2013
March 31, 2016
March 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®
Day O up to Day 60 post-vaccination
Study Arms (2)
Primary Vaccination Group
EXPERIMENTALParticipants 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.
Booster Vaccination Group
ACTIVE COMPARATORParticipants 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
Interventions
0.5 mL, Subcutaneous.
Eligibility Criteria
You may qualify if:
- Children requiring vaccination against Japanese encephalitis
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Bangkok, 10330, Thailand
Unknown Facility
Bangkok, 10400, Thailand
Unknown Facility
Chiang Mai, 50200, Thailand
Unknown Facility
Khon Kaen, 40002, Thailand
Unknown Facility
Nakornnayok, 26120, Thailand
Unknown Facility
Nonthaburi, 11120, Thailand
Unknown Facility
Pathum Thani, 12120, Thailand
Unknown Facility
Songkhla, 90110, Thailand
Related Publications (1)
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.
PMID: 27903416DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur SA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2013
First Posted
November 13, 2013
Study Start
November 1, 2013
Primary Completion
April 1, 2015
Study Completion
October 1, 2015
Last Updated
May 4, 2016
Results First Posted
May 4, 2016
Record last verified: 2016-03