EncephalitisPhase 3NCT01047839
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
A Phase 3 study testing IC51 in people with Encephalitis, run by Valneva Austria GmbH at 10 sites in 5 countries.
Trial summary
The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic Read more about this study
- Who is it for?
- Ages 2 months to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Encephalitis
- What is being tested?
- IC51
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesin 5 countries
- Study dates
- Jan 2010to Aug 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 months to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female healthy children and adolescents aged >=2 months to <18 years at the time of first vaccination
- Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable
- Female subjects: either no childbearing potential or negative pregnancy test. For females after menarche willingness to practice a reliable method of contraception.
- The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7.
Who cannot join
- Clinical manifestation or history of any Flavivirus disease
- Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study
- History of immunodeficiency or immunosuppressive therapy
- Known HIV, HBV or HCV infection
- History of hypersensitivity reactions to other vaccines
- Acute febrile infection at each visit during which the subject receives a vaccination
- Active or passive immunization within 1 week before and 1 week after each IC51 vaccination.
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
United States4 sites
Passport Health
Baltimore, Maryland, 21230
Boston Medical Center
Boston, Massachusetts, 02118
Bronx Lebanon Hospital Center
New York, New York, 10457
Tampa Clinical Research Inc.
Tampa, Florida, 33624
Australia2 sites
Dr. Deb - The Travel Doctor
Brisbane, Queensland, 4001
Travel Doctor - TMVC Australia
Melbourne, Victoria, 3000
Germany2 sites
Berliner Zentrum für Reise- und Tropenmedizin
Berlin, 10117
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries. Uncontrolled, Open-label Phase 3 Study
The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic
- Conditions
- Encephalitis
- Being tested
- IC51
- Keywords
- Pediatric, Japanese Encephalitis Vaccine, non-endemic countries, to assess immunogenicity of purified inactivated Japanese Encephalitis (JE) vaccine IC51
- Medical subject headings
- Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IC51Biological
0.25 ml, 2 i.m. vaccinations at Day 0 and 28
IC51Biological
0.5 ml, 2 i.m. vaccinations at Day 0 and 28
IC51Biological
0.5 ml, 2 i.m. vaccinations at Day 0 and 28
| Study group | Role | What they receive |
|---|---|---|
| >=2 months to <3 years | Experimental | IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28 Receives: Biological: IC51 |
| >=3 to <12 years | Experimental | IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28 Receives: Biological: IC51 |
| >=12 to <18 years | Experimental | IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28 Receives: Biological: IC51 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination
Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.
Measured: until Day 56
Secondary outcomes (8)
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination
Measured: up to Month 7
Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination
Measured: 7 days
Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination
Measured: up to Day 56 and upt to Month 7
Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination
Laboratory parameters were assessed at the Day 28, Day 56 and Month 7 visit. Endpoint reflects abnormal laboratory parameters assessed as clinically significant by the investigator.
Measured: up to Month 7
SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)
Measured: at Day 56 and Month 7
GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7
Measured: at Day 56 and Month 7
SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups
Measured: at Day 56 and Month 7
GMTs at Day 56 and Month 7 Stratified According to Age Groups
Measured: at Day 56 and Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2013
- Study completionAug 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.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Ayad, Dr., Study chair, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047839
- Sponsor's protocol ID
- IC51-322
- Status last verified
- Jun 2020
- First submitted
- 12 Jan 2010
- Last updated
- 30 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries. Uncontrolled, Open-label Phase 3 Study
- ClinicalTrials.gov ID
- NCT01047839
- Acronym / sponsor ID
- IC51-322
- Conditions
- Encephalitis
- Keywords
- Pediatric, Japanese Encephalitis Vaccine, non-endemic countries, to assess immunogenicity of purified inactivated Japanese Encephalitis (JE) vaccine IC51
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Posted 19 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| >=2 months to <3 years | Experimental | Biological: IC51IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28 |
| >=3 to <12 years | Experimental | Biological: IC51IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28 |
| >=12 to <18 years | Experimental | Biological: IC51IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28 |
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female healthy children and adolescents aged >=2 months to <18 years at the time of first vaccination
- Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable
- Female subjects: either no childbearing potential or negative pregnancy test. For females after menarche willingness to practice a reliable method of contraception.
- The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7.
Key exclusion criteria (7 listed)
- Clinical manifestation or history of any Flavivirus disease
- Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study
- History of immunodeficiency or immunosuppressive therapy
- Known HIV, HBV or HCV infection
- History of hypersensitivity reactions to other vaccines
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 |
|---|---|---|
| IC510.25 ml, 2 i.m. vaccinations at Day 0 and 28 | Biological | >=2 months to <3 years |
| IC510.5 ml, 2 i.m. vaccinations at Day 0 and 28 | Biological | >=12 to <18 years |
| IC510.5 ml, 2 i.m. vaccinations at Day 0 and 28 | Biological | >=3 to <12 years |
Primary outcome
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination
Time frame: until Day 56
Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.
8 secondary outcomes
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination
Time frame: up to Month 7
Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination
Time frame: 7 days
Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination
Time frame: up to Day 56 and upt to Month 7
Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination
Time frame: up to Month 7
SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)
Time frame: at Day 56 and Month 7
GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7
Time frame: at Day 56 and Month 7
SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups
Time frame: at Day 56 and Month 7
GMTs at Day 56 and Month 7 Stratified According to Age Groups
Time frame: at Day 56 and Month 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andrea Ayad, Dr. study chair
Valneva Austria GmbH
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IC51 in people with Encephalitis, run by Valneva Austria GmbH at 10 sites in 5 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 4 inclusion and 7 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 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Australia, Germany, Denmark, Sweden. 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 19 Dec 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?
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination (time frame: until Day 56). 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 30 Jun 2020.