Japanese EncephalitisPhase 3NCT01190228

Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With JE-CV

A Phase 3 study testing JE-CV Vaccine and Varicella Vaccine in people with Japanese Encephalitis and Varicella, run by Sanofi Pasteur, a Sanofi Company at 1 site in Philippines.

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 aim of the study is to investigate the memory immune response and the yearly persistence of the immunity against Japanese Encephalitis (JE) after vaccination with Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in participants previously vaccinated with JE-CV vaccine. Read more about this study

Who is it for?: Ages 36 to 42 monthsHealthy volunteers can take part
Conditions the study is for: Japanese Encephalitis, Varicella
What is being tested?: JE-CV Vaccine and Varicella Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 454 participants
Where: 1 sitePhilippines
Study dates: 25 Aug 2010to 12 Oct 2015
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 36 to 42 months
All sexes
Healthy volunteers accepted
Child

An individual had to fulfill all of the following criteria in order to be eligible for trial enrollment:

All Participants

Aged 36 to 42 months on the day of inclusion
Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative
Participant and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures
In good general health, based on medical history and physical examination

For JE-CV vaccine primed group only

Participant who was vaccinated with JE-CV in JEC02 trial (NCT00735644)

An individual fulfilling any of the following criteria was excluded from trial enrollment:

All Participants

Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
Planned participation in another clinical trial during the Day 0 - Month 6 period and for Group 1 up to 5 years for any flavivirus vaccine trial
Receipt of any vaccine* in the 4 weeks preceding the trial vaccination, except for pandemic influenza vaccination, which may be received at least 2 weeks before study vaccines
Planned receipt of any vaccine* in the 4 weeks following the trial vaccination, except for pandemic influenza vaccine. In the event of local or national immunization program with a pandemic influenza vaccine, participants who receive a pandemic influenza vaccine at any time during the trial will not be withdrawn from the trial.
Planned receipt of any JE vaccine during the course of the trial
Administration of any anti-viral within 2 months preceding the trial vaccination and up to 4 weeks following the trial vaccination
Receipt of blood or blood-derived products in the past 3 months, which might interfere with 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 corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, as reported by the parent/legally acceptable representative
History of central nervous system disorder or disease, including seizures and febrile seizures
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 or any underlying illness (such as cardiovascular, kidney, liver or hematological disease or development abnormalities) that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
Except in case of national immunization days with oral polio vaccine

For JE-CV primed participants only

Receipt of any JE vaccine other than JE-CV during JEC02 trial(NCT00735644) and since the end of JEC02 trial

For JE-CV naïve participants only

Previous vaccination against flavivirus disease including JE
History of flavivirus infection either based on clinical suspicion or laboratory proven
Previous vaccination against varicella
Previous vaccination with JE-CV in JEC02 study
History of varicella, confirmed either clinically, serologically, or microbiologically
Known systemic hypersensitivity or anaphylactic/anaphylactoid reaction to neomycin.
Known history of thrombocytopenia or idiopathic thrombocytopenic purpura

Temporary Contraindications:

A prospective participant was not to be included in the study until the following conditions and/or symptoms had resolved:

Receipt of oral or injected antibiotic therapy within 72 hours prior to the first blood draw (for Groups 1 and 2)
Febrile illness (temperature ≥38.0°C [≥100.4°F]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination (for all participants)

The Investigator was to postpone vaccination until the situation/condition resolved. Vaccination could be postponed within the timeframe for vaccination indicated in the protocol trial flowchart.

Trial locations and contacts

1 site in 1 country.

Philippines1 site

Study site
City of Muntinlupa, 1781

Other trials in Philippines

About this study

Official title: Assessment of the Memory Immune Response, Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With a Single Dose of JE-CV and Long-Term Follow-Up

Objectives:

To describe JE immune status before and after JE-CV vaccination in subjects previously vaccinated with JE-CV vaccine
To describe the immune status before and after JE-CV vaccination in JE-naïve control subjects.
To describe the safety (in terms of solicited and unsolicited adverse events) of a single dose of JE-CV vaccine up to 6 months after the last vaccination.
To describe all related serious adverse events (SAEs) and related deaths from 6 months to 5 years after vaccination in JE-CV-primed subjects.

Read the detailed description

Study participants who are previously immunized with JE-CV vaccine will receive a booster dose of the JE-CV vaccine and will be followed up for 5 years for immunogenicity.

The control (JE-CV naïve) participants will receive either one dose of JE-CV vaccine or one dose of varicella vaccine.

All participants will be monitored for safety for 6 month post-vaccination.

Conditions: Japanese Encephalitis, Varicella
Being tested: JE-CV Vaccine, Varicella Vaccine
Keywords: Japanese Encephalitis, Japanese encephalitis chimeric virus vaccine, Varicella, Varicella vaccine
Medical subject headings: Encephalitis, Japanese, Chickenpox

What participants receive

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

JE-CV VaccineBiological
Also called IMOJEV
0.5 mL (single dose), Subcutaneous
Varicella VaccineBiological
Also called OKAVAX®
0.5 mL (single dose), Subcutaneous

Study groups in NCT01190228
Study group	Role	What they receive
Group 1: JE-CV Vaccine Booster	Experimental	Participants previously vaccinated with JE-CV vaccine will receive a booster dose of JE-CV vaccine on Day 0. Receives: Biological: JE-CV Vaccine
Group 2: JE-CV Vaccine First Dose	Experimental	JE-CV vaccine naïve participants will receive a single dose of JE-CV vaccine on Day 0. Receives: Biological: JE-CV Vaccine
Group 3: Varicella Vaccine	Active comparator	JE-CV vaccine naïve participants will receive one dose of Varicella vaccine on Day 0. Receives: Biological: Varicella Vaccine

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 Dose of Live Attenuated JE-CV
The presence of JE virus neutralizing antibodies was measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Day 7 and Day 28) was defined as neutralizing antibody titer ≥ 10 (1/dilution).
Measured: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination
Percentage of Participants With JE Seroconversion Following a Dose of Live Attenuated JE-CV Vaccine
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or participants with pre vaccination titer ≥10 (1/dilution) and a ≥4-fold increase from pre- to post-vaccination.
Measured: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
Measured: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
Measured: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination
Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Flavivirus positive was defined as titers against JE virus ≥10 (1/dilution) or titers against at least 1 dengue serotype ≥10 (1/dilution). Flavivirus negative was defined as titers against JE virus <10 (1/dilution) and titers against the 4 dengue serotypes <10 (1/dilution).
Measured: Day 0 (pre-vaccination)
Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Days 7 and 28 and Years 1, 2, 3, 4, and 5) was defined as neutralizing antibody titer ≥ 10 (1/dilution).
Measured: Day 0 (pre-vaccination) and Days 7 and 28, and Year 1, 2, 3, 4, and 5 post-vaccination
Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
Measured: Day 0 (pre-vaccination) and Days 7 and 28 and Year 1, 2, 3, 4, and 5 post-vaccination
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
Measured: Year 1, 2, 3, 4, and 5 post-vaccination
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection-site reactions: Pain, Incapacitating, unable to perform usual activities. Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, 39.0°C; Headache, Malaise, and Myalgia, Significant; prevents daily activities.
Measured: Day 0 up to Day 14 post-vaccination

Timeline

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

25 Aug 201012 Oct 2015

First posted27 Aug 2010 (estimated)
Study start25 Aug 2010
Primary completion29 Oct 2010
Study completion12 Oct 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: This was an open, controlled, multicenter, Phase III trial. Participants in Group 1 were previously vaccinated at 12 to 18 months of age with a single dose of JE-CV vaccine and were to receive a booster dose of JE-CV vaccine on Day 0. This group was not randomized. JE vaccine naïve control children were randomized to receive one single dose of JE-CV on Day 0 (Group 2) or a varicella vaccination on Day 0 (Group 3).
Masking: None (open label)
Enrolment: 454 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01190228
Sponsor's protocol ID: JEC15
Other IDs: UTN: U1111-1113-3629
Status last verified: Mar 2022
First submitted: 25 Aug 2010
Last updated: 28 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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

Publications

Capeding MR, Alberto ER, Bouckenooghe A, Laot TM, Chansinghakul D, Monfredo C, Machabert T, Feroldi E. Five-Year Antibody Persistence Following a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Booster in JE-CV-Primed Children in the Philippines. J Infect Dis. 2018 Jan 30;217(4):567-571. doi: 10.1093/infdis/jix601.
PubMed 29325161

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

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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
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Active, not recruitingPhase 4
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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: Assessment of the Memory Immune Response, Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With a Single Dose of JE-CV and Long-Term Follow-Up
ClinicalTrials.gov ID: NCT01190228
Acronym / sponsor ID: JEC15
Conditions: Japanese Encephalitis, Varicella
Keywords: Japanese Encephalitis, Japanese encephalitis chimeric virus vaccine, Varicella, Varicella vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 454 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 25 Aug 2010 (actual)
Primary completion: 29 Oct 2010 (actual)
Study completion: 12 Oct 2015 (actual)
First posted: 27 Aug 2010 (estimated)
Results: Posted 8 Nov 2017

Clinical summary

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

Objectives:

To describe JE immune status before and after JE-CV vaccination in subjects previously vaccinated with JE-CV vaccine
To describe the immune status before and after JE-CV vaccination in JE-naïve control subjects.
To describe the safety (in terms of solicited and unsolicited adverse events) of a single dose of JE-CV vaccine up to 6 months after the last vaccination.
To describe all related serious adverse events (SAEs) and related deaths from 6 months to 5 years after vaccination in JE-CV-primed subjects.

Detailed description

Study participants who are previously immunized with JE-CV vaccine will receive a booster dose of the JE-CV vaccine and will be followed up for 5 years for immunogenicity.

The control (JE-CV naïve) participants will receive either one dose of JE-CV vaccine or one dose of varicella vaccine.

All participants will be monitored for safety for 6 month post-vaccination.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: This was an open, controlled, multicenter, Phase III trial. Participants in Group 1 were previously vaccinated at 12 to 18 months of age with a single dose of JE-CV vaccine and were to receive a booster dose of JE-CV vaccine on Day 0. This group was not randomized. JE vaccine naïve control children were randomized to receive one single dose of JE-CV on Day 0 (Group 2) or a varicella vaccination on Day 0 (Group 3).

Arm	Type	Receives
Group 1: JE-CV Vaccine Booster	Experimental	Biological: JE-CV VaccineParticipants previously vaccinated with JE-CV vaccine will receive a booster dose of JE-CV vaccine on Day 0.
Group 2: JE-CV Vaccine First Dose	Experimental	Biological: JE-CV VaccineJE-CV vaccine naïve participants will receive a single dose of JE-CV vaccine on Day 0.
Group 3: Varicella Vaccine	Active comparator	Biological: Varicella VaccineJE-CV vaccine naïve participants will receive one dose of Varicella vaccine on Day 0.

Who may qualify

Ages: 36 to 42 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

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
JE-CV VaccineAlso: IMOJEV0.5 mL (single dose), Subcutaneous	Biological	Group 1: JE-CV Vaccine Booster, Group 2: JE-CV Vaccine First Dose
Varicella VaccineAlso: OKAVAX®0.5 mL (single dose), Subcutaneous	Biological	Group 3: Varicella Vaccine

Primary outcome

Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV
Time frame: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination
The presence of JE virus neutralizing antibodies was measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Day 7 and Day 28) was defined as neutralizing antibody titer ≥ 10 (1/dilution).
Percentage of Participants With JE Seroconversion Following a Dose of Live Attenuated JE-CV Vaccine
Time frame: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or participants with 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 Dose of Live Attenuated JE-CV
Time frame: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV
Time frame: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV
Time frame: Day 0 (pre-vaccination)
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Flavivirus positive was defined as titers against JE virus ≥10 (1/dilution) or titers against at least 1 dengue serotype ≥10 (1/dilution). Flavivirus negative was defined as titers against JE virus <10 (1/dilution) and titers against the 4 dengue serotypes <10 (1/dilution).
Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Time frame: Day 0 (pre-vaccination) and Days 7 and 28, and Year 1, 2, 3, 4, and 5 post-vaccination
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Days 7 and 28 and Years 1, 2, 3, 4, and 5) was defined as neutralizing antibody titer ≥ 10 (1/dilution).
Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Time frame: Day 0 (pre-vaccination) and Days 7 and 28 and Year 1, 2, 3, 4, and 5 post-vaccination
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
Time frame: Year 1, 2, 3, 4, and 5 post-vaccination
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
Time frame: Day 0 up to Day 14 post-vaccination
Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection-site reactions: Pain, Incapacitating, unable to perform usual activities. Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, 39.0°C; Headache, Malaise, and Myalgia, Significant; prevents daily activities.

Results and safety

Results posted to the registry on 8 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
JE-CV Vaccine Booster	349	344
JE-CV Vaccine First Dose	46	46
Varicella Vaccine Group	59	59

Primary outcome: Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV

Time frame: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination. Number. Unit: Percentage of participants

Measure	JE-CV Booster n = 340	JE-CV First Dose n = 39
Day 0 (pre-vaccination)	80.3	0
Day 7 post-vaccination	96.2	15.4
Day 28 post-vaccination	100.0	89.7

Population analysed: Seroprotection against JE-CV vaccine was assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.

Primary outcome: Percentage of Participants With JE Seroconversion Following a Dose of Live Attenuated JE-CV Vaccine

Time frame: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination. Number. Unit: Percentage of participants

Measure	JE-CV Booster n = 340	JE-CV First Dose n = 39
Day 7 post-vaccination	66.8	15.4
Day 28 post-vaccination	95.3	89.7

Population analysed: Seroconversion was assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.

Primary outcome: Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV

Time frame: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titers (1/dilution)

Measure	JE-CV Booster n = 340	JE-CV First Dose n = 39
Day 0 (pre-vaccination)	39.4 (33.7 to 46.0)	5.00 (5.00 to 5.00)
Day 7 post-vaccination	231 (191 to 279)	6.41 (5.11 to 8.05)
Day 28 post-vaccination	2242 (1913 to 2628)	178 (99.7 to 318)

Population analysed: Geometric mean titers of JE virus antibodies were assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.

Primary outcome: Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV

Time frame: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titer ratios (1/dilution)

Measure	JE-CV Booster n = 340	JE-CV First Dose n = 39
Day 7 post-vaccination	5.87 (5.06 to 6.80)	1.28 (1.02 to 1.61)
Day 28 post-vaccination	57.0 (47.8 to 67.9)	35.6 (19.9 to 63.6)

Population analysed: Geometric mean titer ratios of JE virus antibodies were assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.

Adverse events

Time frame: Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
JE-CV Vaccine Booster	3 of 345 (0.9%)	73 of 345 (21.2%)	0 of 345
JE-CV Vaccine First Dose	0 of 46 (0%)	13 of 46 (28.3%)	0 of 46
Varicella Vaccine Group	0 of 59 (0%)	12 of 59 (20.3%)	0 of 59

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 29325161Capeding MR, Alberto ER, Bouckenooghe A, Laot TM, Chansinghakul D, Monfredo C, Machabert T, Feroldi E. Five-Year Antibody Persistence Following a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Booster in JE-CV-Primed Children in the Philippines. J Infect Dis. 2018 Jan 30;217(4):567-571. doi: 10.1093/infdis/jix601.
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 JE-CV Vaccine and Varicella Vaccine in people with Japanese Encephalitis and Varicella, run by Sanofi Pasteur, a Sanofi Company at 1 site in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 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 8 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 JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV (time frame: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination). The study lists 9 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 NCT01190228, 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.