Japanese EncephalitisNCT00596102

Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51

An observational study of Japanese Encephalitis, run by Valneva Austria GmbH.

Completed

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

Trial summary

The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Japanese Encephalitis
What is being tested?: Japanese Encephalitis purified inactivated vaccine
Type of treatment: Vaccines
How many people: 3,258 participants
Where: No sites listed yet
Study dates: Oct 2005to Mar 2011
Phase: Observational
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Approximately 3,300 subjects having completed IC51, JE-VAX or placebo treatment in studies IC51-301 or IC51-302 will take part in the safety follow up, up to month 6 after 1st vaccination in the study IC51-301 (NCT00604708) or IC51-302 (NCT00605085). Only ~160 subjects, who have been treated with IC51 will take part in the immunogenicity and long-term analysis up to month 60.

Who may be able to join

Healthy subjects at least 18 years of age
Written informed consent obtained prior to study entry
Subjects correctly included and having completed clinical studies IC51-301 (NCT00604708) and IC51-302 (NCT00605085) with at least one vaccination

Who cannot join

Inability or unwillingness to provide informed consent and to abide the requirements of the study

About this study

Official title: Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51. An Uncontrolled Phase 3 Follow-up Study

The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.

Conditions: Japanese Encephalitis
Being tested: Japanese Encephalitis purified inactivated 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.

Japanese Encephalitis purified inactivated vaccineBiological
Japanese Encephalitis purified inactivated vaccine

What is being measured

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

Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)
first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302
Measured: 24 months after the first vaccination

Secondary outcomes (3)

Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)
Measured: 6, 12, 36, 48 and 60 months after 1st vaccination
Geometric Mean Titers
Measured: 6, 12, 36, 48 and 60 months
Adverse Events
Measured: 6, 12, 24, 36, 48 and 60 months after 1st vaccination

Timeline

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

Oct 2005Mar 2011

First posted16 Jan 2008 (estimated)
Study startOct 2005
Primary completionMar 2011

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.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Enrolment: 3,258 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00596102
Sponsor's protocol ID: IC51-303
Status last verified: Jun 2014
First submitted: 4 Jan 2008
Last updated: 30 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Taucher C, Kollaritsch H, Dubischar KL. Persistence of the immune response after vaccination with the Japanese encephalitis vaccine, IXIARO(R) in healthy adults: A five year follow-up study. Vaccine. 2019 May 1;37(19):2529-2531. doi: 10.1016/j.vaccine.2019.03.030. Epub 2019 Apr 5.
PubMed 30962094

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?

Official record

Active, not recruitingPhase 4
Immunogenicity, Safety, and Antibody Persistence of Different Immunization Strategies Against Japanese Encephalitis
Japanese Encephalitis Vaccine
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
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
Japanese Encephalitis

All Japanese Encephalitis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51. An Uncontrolled Phase 3 Follow-up Study
ClinicalTrials.gov ID: NCT00596102
Acronym / sponsor ID: IC51-303
Conditions: Japanese Encephalitis
Study type: Observational
Recruitment status: Completed
Enrolment: 3,258 participants (actual)
Lead sponsor: Valneva Austria GmbHIndustry (pharma, biotech, devices)
Study start: Oct 2005
Primary completion: Mar 2011 (actual)
First posted: 16 Jan 2008 (estimated)
Results: Posted 30 Jul 2014

Clinical summary

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

The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.

Study design

Observational model: Cohort

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Approximately 3,300 subjects having completed IC51, JE-VAX or placebo treatment in studies IC51-301 or IC51-302 will take part in the safety follow up, up to month 6 after 1st vaccination in the study IC51-301 (NCT00604708) or IC51-302 (NCT00605085). Only ~160 subjects, who have been treated with IC51 will take part in the immunogenicity and long-term analysis up to month 60.

Key inclusion criteria (3 listed)

Healthy subjects at least 18 years of age
Written informed consent obtained prior to study entry
Subjects correctly included and having completed clinical studies IC51-301 (NCT00604708) and IC51-302 (NCT00605085) with at least one vaccination

Key exclusion criteria (1 listed)

Inability or unwillingness to provide informed consent and to abide the requirements of the study

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
Japanese Encephalitis purified inactivated vaccineJapanese Encephalitis purified inactivated vaccine	Biological	–

Primary outcome

Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)
Time frame: 24 months after the first vaccination
first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302

3 secondary outcomes

Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)
Time frame: 6, 12, 36, 48 and 60 months after 1st vaccination
Geometric Mean Titers
Time frame: 6, 12, 36, 48 and 60 months
Adverse Events
Time frame: 6, 12, 24, 36, 48 and 60 months after 1st vaccination

Results and safety

Results posted to the registry on 30 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IC51	2,283	2,283
JE-VAX	338	338
Placebo	637	637

Primary outcome: Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)

Time frame: 24 months after the first vaccination. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	IC51 n = 181
Value	81.8 (75.7 to 86.7)

Population analysed: subjects enrolled into this study who planned to participate in the long-term immunogenicity part and received IC51 in the respective preceeding study

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IC51 Month 6	15 of 2,283 (0.7%)	78 of 2,283 (3.4%)	Not reported
JE-VAX	2 of 338 (0.6%)	16 of 338 (4.7%)	Not reported
Placebo	7 of 637 (1.1%)	31 of 637 (4.9%)	Not reported
IC51 Month 60	14 of 102 (13.7%)	54 of 102 (52.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30962094Taucher C, Kollaritsch H, Dubischar KL. Persistence of the immune response after vaccination with the Japanese encephalitis vaccine, IXIARO(R) in healthy adults: A five year follow-up study. Vaccine. 2019 May 1;37(19):2529-2531. doi: 10.1016/j.vaccine.2019.03.030. Epub 2019 Apr 5.

Related trials for Japanese Encephalitis

Active, not recruitingPhase 4
Immunogenicity, Safety, and Antibody Persistence of Different Immunization Strategies Against Japanese Encephalitis
Japanese Encephalitis Vaccine
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
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
Japanese Encephalitis

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.

Evelyn Hatzenbichler, Ph.D. study director

Valneva Austria GmbH

Questions about this trial

What is this clinical trial studying?

An observational study of Japanese Encephalitis, run by Valneva Austria GmbH.

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 1 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 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2014). 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 Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) (time frame: 24 months after the first vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00596102, 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 30 Jul 2014.