Japanese EncephalitisNCT02933710
Postmarketing Surveillance Study for IMOJEV® in Republic of Korea
An observational study of Japanese Encephalitis, run by Sanofi Pasteur, a Sanofi Company at 1 site in South Korea.
Trial summary
The purpose of the study is to perform the re-examination of IMOJEV® in routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation. Primary objective: To describe the safety profile of the first dose of IMOJEV® administered under routine health care visit as primary vaccination or as… Read more about this study
- Who is it for?
- Ages 12 months and olderHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jul 2016to 18 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects who receive IMOJEV® (either primary or booster dose) during a routine health-care visit
Who may be able to join
- Informed consent form signed by the subject (for subjects 19 years old and above) or the parent(s) or other legal representative (for subjects under 19 years of age)
- Receipt of the first dose of IMOJEV® (on the day of inclusion) according to approved local insert paper.
Who cannot join
- Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure.
- Subjects who already participated in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postmarketing Surveillance Study for a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Republic of Korea
The purpose of the study is to perform the re-examination of IMOJEV® in routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation.
Primary objective:
- To describe the safety profile of the first dose of IMOJEV® administered under routine health care visit as primary vaccination or as booster.
Read the detailed description
Subjects aged 12 months of age and older and who are given study vaccine during routine health-care visits will be enrolled in the study.
No study vaccine will be supplied or administered as part of this study, subjects will be monitored following routine vaccine administration in clinical settings.
- Conditions
- Japanese Encephalitis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| IMOJEV® Vaccine Group | Participants who are 12 months and older and who are given a first dose of IMOJEV® during a routine health care visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting solicited injection-site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during the trial
Solicited injection-site reactions: Tenderness/Pain, Erythema, and Swelling. Solicited systemic reactions: infants and toddlers (12 to 23 months) Fever (temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite and Irritability; Subjects aged 2 years and above, Fever (Temperature), Headache, Malaise, and Myalgia
Measured: Day 0 up to Day 42 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start21 Jul 2016
- Primary completion18 Oct 2018
- Study completion18 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 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 Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933710
- Sponsor's protocol ID
- JEC18
- Other IDs
- U1111-1174-4824
- Status last verified
- Apr 2022
- First submitted
- 12 Oct 2016
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Kim HS, Oh Y, Korejwo J, Castells VB, Yang K. Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev(R)) in South Korea, 2015-2019. Infect Dis Ther. 2020 Sep;9(3):589-598. doi: 10.1007/s40121-020-00305-6. Epub 2020 May 30.
PubMed 32474892
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarketing Surveillance Study for a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Republic of Korea
- ClinicalTrials.gov ID
- NCT02933710
- Acronym / sponsor ID
- JEC18
- Conditions
- Japanese Encephalitis
- Keywords
- Japanese encephalitis, IMOJEV®, Japanese encephalitis chimeric virus vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2016 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to perform the re-examination of IMOJEV® in routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation.
Primary objective:
- To describe the safety profile of the first dose of IMOJEV® administered under routine health care visit as primary vaccination or as booster.
Detailed description
Subjects aged 12 months of age and older and who are given study vaccine during routine health-care visits will be enrolled in the study.
No study vaccine will be supplied or administered as part of this study, subjects will be monitored following routine vaccine administration in clinical settings.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMOJEV® Vaccine Group | – | –Participants who are 12 months and older and who are given a first dose of IMOJEV® during a routine health care visit |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who receive IMOJEV® (either primary or booster dose) during a routine health-care visit
Key inclusion criteria (2 listed)
- Informed consent form signed by the subject (for subjects 19 years old and above) or the parent(s) or other legal representative (for subjects under 19 years of age)
- Receipt of the first dose of IMOJEV® (on the day of inclusion) according to approved local insert paper.
Key exclusion criteria (2 listed)
- Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure.
- Subjects who already participated in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants reporting solicited injection-site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during the trial
Time frame: Day 0 up to Day 42 post-vaccination
Solicited injection-site reactions: Tenderness/Pain, Erythema, and Swelling. Solicited systemic reactions: infants and toddlers (12 to 23 months) Fever (temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite and Irritability; Subjects aged 2 years and above, Fever (Temperature), Headache, Malaise, and Myalgia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 32474892Kim HS, Oh Y, Korejwo J, Castells VB, Yang K. Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev(R)) in South Korea, 2015-2019. Infect Dis Ther. 2020 Sep;9(3):589-598. doi: 10.1007/s40121-020-00305-6. Epub 2020 May 30.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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 Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Japanese Encephalitis, run by Sanofi Pasteur, a Sanofi Company at 1 site in South Korea.
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 2 inclusion and 2 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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 reporting solicited injection-site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during the trial (time frame: Day 0 up to Day 42 post-vaccination). 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 NCT02933710, 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 25 Apr 2022.