Japanese EncephalitisPhase 4NCT01981967
Post-licensure Safety Study of IMOJEV® in Thailand
A Phase 4 study testing IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine in people with Japanese Encephalitis, run by Sanofi Pasteur, a Sanofi Company at 8 sites in Thailand.
Trial 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®. Read more about this study
- Who is it for?
- Ages 9 months to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis
- What is being tested?
- IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 8 sitesThailand
- Study dates
- Nov 2013to Oct 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Thailand8 sites
Study site
Bangkok, 10330
Study site
Bangkok, 10400
Study site
Chiang Mai, 50200
Study site
Khon Kaen, 40002
Study site
Nakornnayok, 26120
Study site
Nonthaburi, 11120
Study site
Pathum Thani, 12120
Study site
Songkhla, 90110
About this study
Official title: Post-licensure, Phase IV, Safety Study of IMOJEV® in Thailand
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®.
Read the 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.
- Conditions
- Japanese Encephalitis
- Being tested
- IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
- Keywords
- Japanese encephalitis, IMOJEV®, Japanese encephalitis chimeric virus vaccine
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccineBiological
Also called IMOJEV®
0.5 mL, Subcutaneous.
IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccineBiological
Also called IMOJEV®
0.5 mL, Subcutaneous.
| Study group | Role | What they receive |
|---|---|---|
| Primary Vaccination Group | Experimental | 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. Receives: Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine |
| Booster Vaccination Group | Active comparator | 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 Receives: Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV®
Measured: 30 minutes post-vaccination up to Day 60 post-vaccination
Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV®
Measured: 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®
Adverse Events of Special Interest (AESIs) included hypersensitivity/allergic reactions, neurological events (including febrile convulsions), and vaccine failure.
Measured: Day O up to Day 60 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Japanese EncephalitisStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981967
- Sponsor's protocol ID
- JEC17
- Other IDs
- U1111-1127-7052
- Status last verified
- Mar 2016
- First submitted
- 5 Nov 2013
- Last updated
- 4 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 27903416
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-licensure, Phase IV, Safety Study of IMOJEV® in Thailand
- ClinicalTrials.gov ID
- NCT01981967
- Acronym / sponsor ID
- JEC17
- Conditions
- Japanese Encephalitis
- Keywords
- Japanese encephalitis, IMOJEV®, Japanese encephalitis chimeric virus vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Posted 4 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Vaccination Group | Experimental | Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccineParticipants 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 comparator | Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccineParticipants 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 |
Who may qualify
- Ages
- 9 months to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccineAlso: IMOJEV®0.5 mL, Subcutaneous. | Biological | Primary Vaccination Group |
| IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccineAlso: IMOJEV®0.5 mL, Subcutaneous. | Biological | Booster Vaccination Group |
Primary outcome
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27903416Chotpitayasunondh 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Sanofi Pasteur SA
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine in people with Japanese Encephalitis, run by Sanofi Pasteur, a Sanofi Company at 8 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01981967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.