EncephalitisPhase 3NCT01001988

Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers

A Phase 3 study testing Blood sample and JE-CV administered in Study JEC02 in people with Encephalitis and Japanese Encephalitis, run by Sanofi Pasteur, a Sanofi Company at 4 sites in 2 countries.

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

This is a long-term follow-up of the persistence of immune response in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644) . No vaccination was administered during the present long-term follow-up study. Read more about this study

Who is it for?: Ages 2 to 3 yearsHealthy volunteers can take part
Conditions the study is for: Encephalitis, Japanese Encephalitis
What is being tested?: Blood sample and JE-CV administered in Study JEC02
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 596 participants
Where: 4 sitesin 2 countries
Study dates: 7 Aug 2009to 16 Oct 2013
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 3 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations.
Participant who was vaccinated with JE-CV in JEC02 trial and had a pre-vaccination blood sample at baseline in JEC02 trial.
Participant and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.

Who cannot join

Receipt of any JE vaccine other than JE-CV during JEC02 trial and during the period up to inclusion in JEC05 trial.
Planned participation in another clinical trial up to the first year of the follow-up in the present trial.

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Thailand3 sites

Study site
Bangkok, 10330
Study site
Bangkok, 10400
Study site
Khon Kaen, 40002

Other trials in Thailand

Philippines1 site

Study site
City of Muntinlupa, 1781

Other trials in Philippines

About this study

Official title: Long-term Follow-up of Immunogenicity of a Single Dose of JE-CV in Toddlers in Thailand and the Philippines

Primary Objective:

To describe the yearly persistence of humoral immune response to Japanese encephalitis after a single dose of JE-CV

Read the detailed description

Persistence of immune response will be determined in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644). No vaccination will be given in this study.

Conditions: Encephalitis, Japanese Encephalitis
Being tested: Blood sample, JE-CV administered in Study JEC02
Keywords: Encephalitis, Japanese Encephalitis, Japanese Encephalitis Chimeric Virus Vaccine, Toddlers
Medical subject headings: Encephalitis, Encephalitis, Japanese

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood sampleOther
Blood sample for immunogenicity assessment
JE-CV administered in Study JEC02Biological
Participants received a single dose of JE-CV at 12 to 18 months of age in Study JEC02. No vaccination was administered in Study JEC05

Study groups in NCT01001988
Study group	Role	What they receive
Study group	Experimental	Participants received a single dose of JE-CV administered in Study JEC02. In Study JEC05 there were yearly visits with blood samples taken for immunogenicity assessment. Receives: Other: Blood sample; Biological: JE-CV administered in Study JEC02

What is being measured

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

Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV
Seroprotection was defined as the proportion of participants with Japanese encephalitis virus neutralizing antibody titers ≥10 1/dil as measured by a JE 50% plaque reduction neutralization test (PRNT50).
Measured: Day 0 (pre-vaccination) from study JEC02, Day 28 post-vaccination from study JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination
Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV
Geometric mean titers of Japanese encephalitis virus antibodies were assessed using the PRNT50 test.
Measured: Day 0 (pre-vaccination) from JEC02, Day 28 post-vaccination from JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination

Timeline

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

7 Aug 200916 Oct 2013

First posted27 Oct 2009 (estimated)
Study start7 Aug 2009
Primary completion16 Oct 2013
Study completion16 Oct 2013

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 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: 596 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01001988
Sponsor's protocol ID: JEC05
Other IDs: U1111-1112-2127
Status last verified: Oct 2017
First submitted: 23 Oct 2009
Last updated: 29 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Follow-up of Immunogenicity of a Single Dose of JE-CV in Toddlers in Thailand and the Philippines
ClinicalTrials.gov ID: NCT01001988
Acronym / sponsor ID: JEC05
Conditions: Encephalitis, Japanese Encephalitis
Keywords: Encephalitis, Japanese Encephalitis, Japanese Encephalitis Chimeric Virus Vaccine, Toddlers
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 596 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 7 Aug 2009 (actual)
Primary completion: 16 Oct 2013 (actual)
Study completion: 16 Oct 2013 (actual)
First posted: 27 Oct 2009 (estimated)
Results: Posted 29 Nov 2017

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 yearly persistence of humoral immune response to Japanese encephalitis after a single dose of JE-CV

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study group	Experimental	Other: Blood sample, Biological: JE-CV administered in Study JEC02Participants received a single dose of JE-CV administered in Study JEC02. In Study JEC05 there were yearly visits with blood samples taken for immunogenicity assessment.

Who may qualify

Ages: 2 to 3 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations.
Participant who was vaccinated with JE-CV in JEC02 trial and had a pre-vaccination blood sample at baseline in JEC02 trial.
Participant and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.

Key exclusion criteria (2 listed)

Receipt of any JE vaccine other than JE-CV during JEC02 trial and during the period up to inclusion in JEC05 trial.
Planned participation in another clinical trial up to the first year of the follow-up in the present trial.

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
Blood sampleBlood sample for immunogenicity assessment	Other	Study group
JE-CV administered in Study JEC02Participants received a single dose of JE-CV at 12 to 18 months of age in Study JEC02. No vaccination was administered in Study JEC05	Biological	Study group

Primary outcome

Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV
Time frame: Day 0 (pre-vaccination) from study JEC02, Day 28 post-vaccination from study JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination
Seroprotection was defined as the proportion of participants with Japanese encephalitis virus neutralizing antibody titers ≥10 1/dil as measured by a JE 50% plaque reduction neutralization test (PRNT50).
Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV
Time frame: Day 0 (pre-vaccination) from JEC02, Day 28 post-vaccination from JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination
Geometric mean titers of Japanese encephalitis virus antibodies were assessed using the PRNT50 test.

Results and safety

Results posted to the registry on 29 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Group	596	479

Primary outcome: Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV

Time frame: Day 0 (pre-vaccination) from study JEC02, Day 28 post-vaccination from study JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination. Number. Unit: Percentage of participants

Measure	Study Group n = 585
Day 0 (pre-vaccination)	2.6
Day 28 post-vaccination	100.0
Year 1 post-vaccination	88.2
Year 2 post-vaccination	90.0
Year 3 post-vaccination	93.1
Year 4 post-vaccination	87.6
Year 5 post-vaccination	85.4

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

Primary outcome: Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV

Time frame: Day 0 (pre-vaccination) from JEC02, Day 28 post-vaccination from JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titers (1/dil)

Measure	Study Group n = 585
Day 0 (pre-vaccination)	5.13 (5.06 to 5.21)
Day 28 post-vaccination	252 (224 to 284)
Year 1 post-vaccination	76.8 (67.4 to 87.6)
Year 2 post-vaccination	81.4 (71.7 to 92.6)
Year 3 post-vaccination	132 (114 to 153)
Year 4 post-vaccination	85.8 (74.7 to 98.6)
Year 5 post-vaccination	63.3 (54.8 to 73.0)

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

Adverse events

Time frame: Safety data were not collected in this trial as no vaccine was administered. Only serious adverse events (SAEs) related to the vaccination in study JEC02 were collected. Overall, no related SAEs (including death) were reported from 6 months to 5 years post-vaccination in JEC02.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Group	0 of 591 (0%)	0 of 591 (0%)	0 of 591

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Inc.

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Blood sample and JE-CV administered in Study JEC02 in people with Encephalitis and Japanese Encephalitis, run by Sanofi Pasteur, a Sanofi Company at 4 sites in 2 countries.

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 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 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Thailand, Philippines. 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 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 Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV (time frame: Day 0 (pre-vaccination) from study JEC02, Day 28 post-vaccination from study JEC02, and at Years 1, 2, 3, 4, and 5 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 NCT01001988.

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 29 Nov 2017.