Japanese EncephalitisPhase 3NCT01900444
Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea
A Phase 3 study testing IMOJEV in people with Japanese Encephalitis, run by Sanofi Pasteur, a Sanofi Company at 8 sites in South Korea.
Trial summary
The aim of this study was to document the immunogenicity and safety of a booster dose of IMOJEV administered at least 12 months after the primary dose. Primary objective: To describe the immune response to Japanese Encephalitis (JE) before and 28 days after a booster dose of IMOJEV administered at least 12 months… Read more about this study
- Who is it for?
- Ages 2 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis
- What is being tested?
- IMOJEV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 11 Jul 2013to 11 Mar 2014
- Phase
- Phase 3
- 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 2 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Must have participated in study JEC12 and received 1 dose of IMOJEV at least 12 months before booster vaccination
- Age 2 to 4 years on the day of inclusion
- In good general health at the time of inclusion
- Informed Concent Form signed and dated by parent(s) or another legally acceptable representative(s)
- Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and comply with all study procedures.
Who cannot join
- Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the study vaccination
- Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Receipt of immune globulins, blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response
- Previous vaccination against flavivirus disease, including JE, with another vaccine, except with IMOJEV® while participating in JEC12
Show all 17Show fewer
- Administration of any anti-viral within 2 months preceding Visit 1 and up to the 4 weeks following the study vaccination
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination, except for inactivated influenza vaccination, which may be received at least 2 weeks before the study vaccine
- History of central nervous system disorder or disease, including seizures
- Planned receipt of any JE vaccine during the course of the study
- History of flavivirus infection (confirmed either clinically, serologically or virologically)
- Administration of systemic corticosteroids for more than 2 consecutive weeks within the 4 weeks preceding vaccination
- Thrombocytopenia, contraindicating vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating vaccination
- Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection 3 days before vaccination as well as the day of vaccination, according to Investigator judgment. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- In an emergency setting or hospitalized involuntarily
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Investigational Site 004
Gyeonggi-do
Investigational Site 010
Gyeonggi-do
Investigational Site 001
Seoul
Investigational Site 005
Seoul
Investigational Site 006
Seoul
Investigational Site 008
Seoul
Investigational Site 009
Seoul
Investigational Site 007
Wŏnju
About this study
Official title: Immunogenicity and Safety Exploration of a Booster Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Given One Year After Primary Immunization in Healthy Children in South Korea
The aim of this study was to document the immunogenicity and safety of a booster dose of IMOJEV administered at least 12 months after the primary dose.
Primary objective:
- To describe the immune response to Japanese Encephalitis (JE) before and 28 days after a booster dose of IMOJEV administered at least 12 months after primary vaccination with IMOJEV.
Exploratory objectives:
- To describe the safety profile of a booster dose of IMOJEV® .
Read the detailed description
Participants who previously participated in Study JEC12 (NCT01396512) and were primed with IMOJEV received a booster dose of IMOJEV at least 12 months after the primary dose. Participants were assessed for immune response before and on Day 28 after the booster dose and were monitored for safety through Day 28 post-vaccination for non-serious adverse events (AEs) and up to 6 months post-vaccination for serious AEs The duration of each participant's participation in the study was approximately 6 months.
- Conditions
- Japanese Encephalitis
- Being tested
- IMOJEV
- Keywords
- Japanese encephalitis, Japanese encephalitis chimeric virus vaccine, IMOJEV®
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMOJEVBiological
Also called Japanese Encephalitis Chimeric Virus Vaccine
0.5 mL, Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| IMOJEV Group | Experimental | Participants who received a single dose of IMOJEV in study JEC12 (NCT01396512) will receive a booster dose in this study. Receives: Biological: IMOJEV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With JE Seroprotection Before and Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
JE virus neutralizing antibodies were measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before and after IMOJEV vaccination was defined as antibody titers ≥ 10 (1/dilution).
Measured: Day 0 (pre-booster) and Day 28 post-booster injection
Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4-fold increase of titers from pre- to post-vaccination.
Measured: Day 28 post-booster injection
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
JE virus neutralizing antibodies were measured using PRNT50 test.
Measured: Day 0 (pre-booster) and Day 28 post-booster injection
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
JE virus neutralizing antibodies were measured using PRNT50.
Measured: Day 0 (pre-booster) and Day 28 post-booster injection
Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
JE virus neutralizing antibodies were measured using PRNT50. Seroprotection was defined as neutralizing antibody titer ≥ 10 (1/dilution).
Measured: Day 0 (pre-booster) and Day 28 post-booster injection
Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4 fold increase from pre- to post-vaccination.
Measured: Day 28 post-booster injection
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization
JE virus neutralizing antibodies were measured using PRNT50.
Measured: Day 0 (pre-booster) and Day 28 post-booster injection
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
JE virus neutralizing antibodies were measured using PRNT50.
Measured: Day 0 (pre-booster) and Day 28 post-booster injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study start11 Jul 2013
- Primary completion11 Mar 2014
- Study completion11 Mar 2014
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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 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 South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900444
- Sponsor's protocol ID
- JEC22
- Other IDs
- U1111-1127-7153
- Status last verified
- Mar 2022
- First submitted
- 11 Jul 2013
- Last updated
- 28 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Exploration of a Booster Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Given One Year After Primary Immunization in Healthy Children in South Korea
- ClinicalTrials.gov ID
- NCT01900444
- Acronym / sponsor ID
- JEC22
- Conditions
- Japanese Encephalitis
- Keywords
- Japanese encephalitis, Japanese encephalitis chimeric virus vaccine, IMOJEV®
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2013 (actual)
- Primary completion
- 11 Mar 2014 (actual)
- Study completion
- 11 Mar 2014 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Posted 13 Dec 2017
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 was to document the immunogenicity and safety of a booster dose of IMOJEV administered at least 12 months after the primary dose.
Primary objective:
- To describe the immune response to Japanese Encephalitis (JE) before and 28 days after a booster dose of IMOJEV administered at least 12 months after primary vaccination with IMOJEV.
Exploratory objectives:
- To describe the safety profile of a booster dose of IMOJEV® .
Detailed description
Participants who previously participated in Study JEC12 (NCT01396512) and were primed with IMOJEV received a booster dose of IMOJEV at least 12 months after the primary dose. Participants were assessed for immune response before and on Day 28 after the booster dose and were monitored for safety through Day 28 post-vaccination for non-serious adverse events (AEs) and up to 6 months post-vaccination for serious AEs The duration of each participant's participation in the study was approximately 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMOJEV Group | Experimental | Biological: IMOJEVParticipants who received a single dose of IMOJEV in study JEC12 (NCT01396512) will receive a booster dose in this study. |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Must have participated in study JEC12 and received 1 dose of IMOJEV at least 12 months before booster vaccination
- Age 2 to 4 years on the day of inclusion
- In good general health at the time of inclusion
- Informed Concent Form signed and dated by parent(s) or another legally acceptable representative(s)
- Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and comply with all study procedures.
Key exclusion criteria (17 listed)
- Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the study vaccination
- Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Receipt of immune globulins, blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response
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 |
|---|---|---|
| IMOJEVAlso: Japanese Encephalitis Chimeric Virus Vaccine0.5 mL, Subcutaneous | Biological | IMOJEV Group |
Primary outcome
Percentage of Participants With JE Seroprotection Before and Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
Time frame: Day 0 (pre-booster) and Day 28 post-booster injection
JE virus neutralizing antibodies were measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before and after IMOJEV vaccination was defined as antibody titers ≥ 10 (1/dilution).
Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
Time frame: Day 28 post-booster injection
JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4-fold increase of titers from pre- to post-vaccination.
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
Time frame: Day 0 (pre-booster) and Day 28 post-booster injection
JE virus neutralizing antibodies were measured using PRNT50 test.
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
Time frame: Day 0 (pre-booster) and Day 28 post-booster injection
JE virus neutralizing antibodies were measured using PRNT50.
Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
Time frame: Day 0 (pre-booster) and Day 28 post-booster injection
JE virus neutralizing antibodies were measured using PRNT50. Seroprotection was defined as neutralizing antibody titer ≥ 10 (1/dilution).
Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
Time frame: Day 28 post-booster injection
JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4 fold increase from pre- to post-vaccination.
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization
Time frame: Day 0 (pre-booster) and Day 28 post-booster injection
JE virus neutralizing antibodies were measured using PRNT50.
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
Time frame: Day 0 (pre-booster) and Day 28 post-booster injection
JE virus neutralizing antibodies were measured using PRNT50.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 South Korea
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IMOJEV in people with Japanese Encephalitis, run by Sanofi Pasteur, a Sanofi Company at 8 sites 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 5 inclusion and 17 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 28 Mar 2022. 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 13 Dec 2017). 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?
Percentage of Participants With JE Seroprotection Before and Following a Booster Dose of IMOJEV Given One Year After Primary Immunization (time frame: Day 0 (pre-booster) and Day 28 post-booster injection). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2022.