Post-licensure Safety Study of IMOJEV® in Thailand
Primary Purpose
Japanese Encephalitis
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Japanese Encephalitis focused on measuring Japanese encephalitis, IMOJEV®, Japanese encephalitis chimeric virus vaccine
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Primary Vaccination Group
Booster Vaccination Group
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV®
Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV®
Secondary Outcome Measures
Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®
Adverse Events of Special Interest (AESIs) included hypersensitivity/allergic reactions, neurological events (including febrile convulsions), and vaccine failure.
Full Information
NCT ID
NCT01981967
First Posted
November 5, 2013
Last Updated
March 31, 2016
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT01981967
Brief Title
Post-licensure Safety Study of IMOJEV® in Thailand
Official Title
Post-licensure, Phase IV, Safety Study of IMOJEV® in Thailand
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Encephalitis
Keywords
Japanese encephalitis, IMOJEV®, Japanese encephalitis chimeric virus vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Primary Vaccination Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Booster Vaccination Group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
Other Intervention Name(s)
IMOJEV®
Intervention Description
0.5 mL, Subcutaneous.
Intervention Type
Biological
Intervention Name(s)
IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
Other Intervention Name(s)
IMOJEV®
Intervention Description
0.5 mL, Subcutaneous.
Primary Outcome Measure Information:
Title
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
Title
Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV®
Time Frame
Day O up to Day 60 post-vaccination
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®
Description
Adverse Events of Special Interest (AESIs) included hypersensitivity/allergic reactions, neurological events (including febrile convulsions), and vaccine failure.
Time Frame
Day O up to Day 60 post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur SA
Official's Role
Study Director
Facility Information:
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
City
Nakornnayok
ZIP/Postal Code
26120
Country
Thailand
City
Nonthaburi
ZIP/Postal Code
11120
Country
Thailand
City
Pathumthani
ZIP/Postal Code
12120
Country
Thailand
City
Songkla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
27903416
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.
Results Reference
derived
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
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Post-licensure Safety Study of IMOJEV® in Thailand
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