Japanese EncephalitisPhase 3NCT02492165

Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects

A Phase 3 study testing Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®) in people with Japanese Encephalitis, run by Sanofi Pasteur, a Sanofi Company at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to describe the immunogenicity and safety of IMOJEV® in adult and pediatric populations in Vietnam and serve a bridging study to compare immunogenicity, reactogenicity, and safety data obtained with IMOJEV® in the Vietnamese population with data from other Asian pediatric populations. Read more about this study

Who is it for?: Ages 9 months to 60 yearsHealthy volunteers can take part
Conditions the study is for: Japanese Encephalitis
What is being tested?: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 250 participants
Where: 1 siteVietnam
Study dates: Jun 2015to Jun 2016
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 9 months to 60 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Aged 9 months through 60 years on the day of inclusion.
For adults: Informed consent form has been signed and dated by the subject. For minors: Informed consent form has been signed and dated by the parent or legally acceptable representative. In addition, in accordance with the Institution Ethics Committee / Institution Review Board requirements and as appropriate for the age of the subject, the subject may be required to sign and date the informed consent form if aged 12 to 17 years or assent form if aged 8 to 11 years.
Subject and parent(s)/legally acceptable representative(s) are able to attend all scheduled visits and comply with all study procedures.

Who cannot join

Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination).
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.
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, except for inactivated influenza vaccination, which may be received at least 2 weeks before the study vaccine
Previous vaccination against flavivirus disease, including Japanese Encephalitis (JE), dengue, and yellow fever.
Receipt of immune globulins, blood, or blood-derived products in the past 3 months that might interfere with the assessment of the immune response.
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 (for more than 2 consecutive weeks within the 4 weeks preceding vaccination).

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History of flavivirus infection (confirmed either clinically, serologically, or virologically).
History of central nervous system disorder or disease, including seizures.
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances.
Known thrombocytopenia, contraindicating vaccination.
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating vaccination.
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
Current alcohol abuse or drug addiction.
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.
Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on 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.
Receipt of any chronic anti-viral in the 2 months preceding the study vaccination or planned receipt of any anti-viral in the 4 weeks following the study vaccination. Short-term antiviral drugs for flu or herpes can be administered provided there is a wash-out period of 1 week before the administration of the vaccine.
Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

Preventive Medicine Centre of Hoa Binh Province
Hòa Bình

Other trials in Vietnam

About this study

Official title: Immunogenicity and Safety of a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Given to Healthy Subjects in Vietnam

Primary objective:

To describe the safety profile of a single dose of IMOJEV®.

Secondary objectives:

To evaluate the immune response to JE 28 days after the administration of a single dose of IMOJEV® in healthy Vietnamese subjects aged from 9 months to 60 years.

Read the detailed description

Study participants will be enrolled by age group and will each receive one injection of IMOJEV® on Day 0 given as primary vaccination. They will be assessed for immunogenicity and safety, post-vaccination.

Conditions: Japanese Encephalitis
Being tested: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)
Keywords: Japanese Encephalitis, Japanese encephalitis chimeric virus vaccine, IMOJEV®, Live attenuated 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.

Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)Biological
Also called IMOJEV®
0.5 mL, Subcutaneous
Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)Biological
Also called IMOJEV®
0.5 mL, Subcutaneous
Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)Biological
Also called IMOJEV®
0.5 mL, Subcutaneous
Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)Biological
Also called IMOJEV®
0.5 mL, Subcutaneous

Study groups in NCT02492165
Study group	Role	What they receive
Age 9 Months through 4 Years Group	Experimental	Participants age 9 Months through 4 Years old at enrollment Receives: Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)
Age 5 Years through 11 Years Group	Experimental	Participants age 5 Years through 11 Years old at enrollment Receives: Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)
Age 12 Years through 17 Years Group	Experimental	Participants age 12 Years through 17 Years old at enrollment Receives: Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)
Age 18 Years through 60 Years Group	Experimental	Participants age 18 Years through 60 Years old at enrollment Receives: Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Solicited injection-site: ≤ 23 months age: Tenderness, Erythema, and Swelling. For ≥ 2 years age: Pain, Erythema, and Swelling. Solicited systemic reactions: ≤ 23 months age, Fever (temperature) Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability, For ≥ 2 years age, Fever (temperature) Headache, Malaise, and Myalgia.
Grade 3: Tenderness, Cries when injected limb is moved; Pain, Incapacitating, unable to perform usual activities or Significant; prevents daily activity (≥ 12 years); Erythema and Swelling (≤23 months to 11 years), ≥50 mm or >100 mm (≥ 12 years).
Grade 3 Fever, > 39.5°C (≤ 23 months) or ≥39.0°C (≥ 2 years); Vomiting, ≥ 6 episodes per 24 hours; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time; Appetite loss, Refuses ≥ 3 feeds / meals; Irritability, Inconsolable. Headache, Malaise, and Myalgia, Significant; prevents daily activity.
Measured: Day 0 up to Day 14 post-vaccination
Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroprotection was defined as antibody titer levels ≥10 (1/dil).
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) and post-vaccination titer ≥10 (1/dil) or participants with pre vaccination titer ≥10 (1/dil) and a ≥4-fold increase from pre- to post-vaccination.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50).
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Jun 2016

First posted8 Jul 2015 (estimated)
Study startJun 2015
Primary completionMar 2016
Study completionJun 2016

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 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02492165
Sponsor's protocol ID: JEC13
Other IDs: U1111-1143-8142
Status last verified: Mar 2022
First submitted: 5 Jul 2015
Last updated: 28 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

Vu TD, Nguyen QD, Tran HTA, Bosch-Castells V, Zocchetti C, Houillon G. Immunogenicity and safety of a single dose of a live attenuated Japanese encephalitis chimeric virus vaccine in Vietnam: A single-arm, single-center study. Int J Infect Dis. 2018 Jan;66:137-142. doi: 10.1016/j.ijid.2017.10.010. Epub 2017 Nov 27.
PubMed 29081368

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
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Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
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Not yet recruitingObservational study
Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus
Japanese Encephalitis
Active, not recruitingPhase 4
Monitoring JE Antibody Levels in Healthy Populations and Immunization Strategy in Low-Prevalence Areas
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All Japanese Encephalitis trials

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 of a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Given to Healthy Subjects in Vietnam
ClinicalTrials.gov ID: NCT02492165
Acronym / sponsor ID: JEC13
Conditions: Japanese Encephalitis
Keywords: Japanese Encephalitis, Japanese encephalitis chimeric virus vaccine, IMOJEV®, Live attenuated vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Collaborators: National Institute of Hygiene and Epidemiology, Vietnam
Study start: Jun 2015
Primary completion: Mar 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 8 Jul 2015 (estimated)
Results: Posted 29 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary objective:

To describe the safety profile of a single dose of IMOJEV®.

Secondary objectives:

To evaluate the immune response to JE 28 days after the administration of a single dose of IMOJEV® in healthy Vietnamese subjects aged from 9 months to 60 years.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Age 9 Months through 4 Years Group	Experimental	Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)Participants age 9 Months through 4 Years old at enrollment
Age 5 Years through 11 Years Group	Experimental	Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)Participants age 5 Years through 11 Years old at enrollment
Age 12 Years through 17 Years Group	Experimental	Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)Participants age 12 Years through 17 Years old at enrollment
Age 18 Years through 60 Years Group	Experimental	Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)Participants age 18 Years through 60 Years old at enrollment

Who may qualify

Ages: 9 months to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Aged 9 months through 60 years on the day of inclusion.
For adults: Informed consent form has been signed and dated by the subject. For minors: Informed consent form has been signed and dated by the parent or legally acceptable representative. In addition, in accordance with the Institution Ethics Committee / Institution Review Board requirements and as appropriate for the age of the subject, the subject may be required to sign and date the informed consent form if aged 12 to 17 years or assent form if aged 8 to 11 years.
Subject and parent(s)/legally acceptable representative(s) are able to attend all scheduled visits and comply with all study procedures.

Key exclusion criteria (17 listed)

Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination).
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.
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, except for inactivated influenza vaccination, which may be received at least 2 weeks before the study vaccine
Previous vaccination against flavivirus disease, including Japanese Encephalitis (JE), dengue, and yellow fever.
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
Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)Also: IMOJEV®0.5 mL, Subcutaneous	Biological	Age 9 Months through 4 Years Group
Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)Also: IMOJEV®0.5 mL, Subcutaneous	Biological	Age 5 Years through 11 Years Group
Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)Also: IMOJEV®0.5 mL, Subcutaneous	Biological	Age 12 Years through 17 Years Group
Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)Also: IMOJEV®0.5 mL, Subcutaneous	Biological	Age 18 Years through 60 Years Group

Primary outcome

Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Time frame: Day 0 up to Day 14 post-vaccination
Solicited injection-site: ≤ 23 months age: Tenderness, Erythema, and Swelling. For ≥ 2 years age: Pain, Erythema, and Swelling. Solicited systemic reactions: ≤ 23 months age, Fever (temperature) Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability, For ≥ 2 years age, Fever (temperature) Headache, Malaise, and Myalgia. Grade 3: Tenderness, Cries when injected limb is moved; Pain, Incapacitating, unable to perform usual activities or Significant; prevents daily activity (≥ 12 years); Erythema and Swelling (≤23 months to 11 years), ≥50 mm or >100 mm (≥ 12 years). Grade 3 Fever, > 39.5°C (≤ 23 months) or ≥39.0°C (≥ 2 years); Vomiting, ≥ 6 episodes per 24 hours; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time; Appetite loss, Refuses ≥ 3 feeds / meals; Irritability, Inconsolable. Headache, Malaise, and Myalgia, Significant; prevents daily activity.
Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroprotection was defined as antibody titer levels ≥10 (1/dil).
Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) and post-vaccination titer ≥10 (1/dil) or participants with pre vaccination titer ≥10 (1/dil) and a ≥4-fold increase from pre- to post-vaccination.
Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50).

Results and safety

Results posted to the registry on 29 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
9 Months to 4 Years	100	100
5 to 11 Years	60	59
12 to 17 Years	60	60
18 to 60 Years	30	30

Primary outcome: Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)

Time frame: Day 0 up to Day 14 post-vaccination. Number. Unit: Participants

Measure	9 Months to 4 Years n = 100	5 to 11 Years n = 60	12 to 17 Years n = 60	18 to 60 Years n = 30
Injection-site Tenderness/Pain	35	8	11	8
Grade 3 Injection-site Tenderness/Pain	0	0	0	0
Injection-site Erythema	6	3	0	0
Grade 3 Injection-site Erythema	0	0	0	0
Injection-site Swelling	1	1	0	0
Grade 3 Injection-site Swelling	0	0	0	0
Fever	14	0	0	0
Grade 3 Fever	2	1	0	0

Population analysed: Solicited injection site and solicited systemic reactions were assessed in the Safety Analysis Set.

Primary outcome: Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)

Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination. Number. Unit: Percentage of participants

Measure	9 Months to 4 Years n = 76	5 to 11 Years n = 60	12 to 17 Years n = 19	18 to 60 Years n = 5
Pre-vaccination (Day 0)	0.0	0.0	0.0	0.0
Post-vaccination (Day 28)	97.4	100.0	100.0	100.0

Population analysed: Seroprotection was assessed in the Per-Protocol Analysis Set.

Primary outcome: Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)

Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination. Number. Unit: Percentage of participants

Measure	9 Months to 4 Years n = 76	5 to 11 Years n = 60	12 to 17 Years n = 19	18 to 60 Years n = 5
Value	97.4	100.0	100.0	100.0

Population analysed: Seroconversion was assessed in the Per-Protocol Analysis Set.

Primary outcome: Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)

Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titers (1/dil)

Measure	9 Months to 4 Years n = 76	5 to 11 Years n = 34	12 to 17 Years n = 19	18 to 60 Years n = 5
Pre-vaccination (Day 0)	5.00 (5.00 to 5.00)	5.00 (5.00 to 5.00)	5.00 (5.00 to 5.00)	5.00 (5.00 to 5.00)
Post-vaccination (Day 28)	277 (192 to 399)	1738 (1055 to 2862)	1481 (762 to 2878)	970 (65.6 to 14352)

Population analysed: Geometric mean titers were assessed in the Per Protocol Analysis Set.

Adverse events

Time frame: Adverse event data were collected from Day 0 up to Day 28 post vaccination.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
9 Months to 4 Years	1 of 100 (1%)	38 of 100 (38%)	Not reported
5 to 11 Years	0 of 60 (0%)	9 of 60 (15%)	Not reported
12 to 17 Years	1 of 60 (1.7%)	16 of 60 (26.7%)	Not reported
18 to 60 Years	0 of 30 (0%)	10 of 30 (33.3%)	Not reported

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.
Derived from this study: PubMed 29081368Vu TD, Nguyen QD, Tran HTA, Bosch-Castells V, Zocchetti C, Houillon G. Immunogenicity and safety of a single dose of a live attenuated Japanese encephalitis chimeric virus vaccine in Vietnam: A single-arm, single-center study. Int J Infect Dis. 2018 Jan;66:137-142. doi: 10.1016/j.ijid.2017.10.010. Epub 2017 Nov 27.
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 SA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®) in people with Japanese Encephalitis, run by Sanofi Pasteur, a Sanofi Company at 1 site in Vietnam.

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 3 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 1 site in Vietnam. 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 29 Nov 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 With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) (time frame: Day 0 up to Day 14 post-vaccination). The study lists 4 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 NCT02492165, 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 28 Mar 2022.