Post-licensure Safety Study of IMOJEV® in Thailand
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ClinicalTrials.gov Identifier: NCT01981967 |
Recruitment Status :
Completed
First Posted : November 13, 2013
Results First Posted : May 4, 2016
Last Update Posted : May 4, 2016
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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®.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Japanese Encephalitis | Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10000 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Post-licensure, Phase IV, Safety Study of IMOJEV® in Thailand |
Study Start Date : | November 2013 |
Actual Primary Completion Date : | April 2015 |
Actual Study Completion Date : | October 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Primary Vaccination Group
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.
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Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
0.5 mL, Subcutaneous.
Other Name: IMOJEV® |
Active Comparator: Booster Vaccination Group
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
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Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
0.5 mL, Subcutaneous.
Other Name: IMOJEV® |
- 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 ]
- Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV® [ Time Frame: Day O up to Day 60 post-vaccination ]
- Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV® [ Time Frame: 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.

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Ages Eligible for Study: | 9 Months to 4 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981967
Thailand | |
Bangkok, Thailand, 10330 | |
Bangkok, Thailand, 10400 | |
Chiang Mai, Thailand, 50200 | |
Khon Kaen, Thailand, 40002 | |
Nakornnayok, Thailand, 26120 | |
Nonthaburi, Thailand, 11120 | |
Pathumthani, Thailand, 12120 | |
Songkla, Thailand, 90110 |
Study Director: | Medical Director | Sanofi Pasteur SA |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT01981967 |
Other Study ID Numbers: |
JEC17 U1111-1127-7052 ( Other Identifier: WHO ) |
First Posted: | November 13, 2013 Key Record Dates |
Results First Posted: | May 4, 2016 |
Last Update Posted: | May 4, 2016 |
Last Verified: | March 2016 |
Japanese encephalitis IMOJEV® Japanese encephalitis chimeric virus vaccine |
Encephalitis, Japanese Encephalitis Brain Diseases Central Nervous System Diseases Nervous System Diseases Encephalitis, Arbovirus Encephalitis, Viral Central Nervous System Viral Diseases Central Nervous System Infections Infections |
Infectious Encephalitis Arbovirus Infections Vector Borne Diseases Virus Diseases RNA Virus Infections Flavivirus Infections Flaviviridae Infections Vaccines Immunologic Factors Physiological Effects of Drugs |